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1 online resource (xii, 256 pages) : illustrations (some color).
  • PrefaceTable of Contents...Contributing Authors...Part I Introduction1. Evaluating Nanomedicines: Obstacles and AdvancementsMagdalena Swierczewska, Rachael M. Crist, and Scott E. McNeilPart II Sterility and Endotoxin Testing2. Detection of Bacterial Contamination in Nanoparticle Formulations by Agar Plate TestTimothy M. Potter, Barry W. Neun, Anna N. Ilinskaya, and Marina A. Dobrovolskaia3. Considerations and Some Practical Solutions to Overcome Nanoparticle Interference with LAL Assays and to Avoid Endotoxin Contamination in NanoformulationsBarry W. Neun and Marina A. DobrovolskaiaPart III Physicochemical Characterization4. Elemental Analysis in Biological Matrices Using ICP-MSMatthew N. Hansen and Jeffrey D. Clogston5. PEG Quantitation Using Reversed Phase High Performance Liquid Chromatography and Charged Aerosol DetectionMackensie C. Smith and Jeffrey D. Clogston6. Quantitation of Surface Coating on Nanoparticles Using Thermogravimetric AnalysisAlpana A. Dongargaonkar and Jeffrey D. Clogston7. Immunoelectron Microscopy for Visualization of NanoparticlesSarah R. Anderson, David Parmiter, Ulrich Baxa, and Kunio Nagashima 8. Imaging of Liposomes by Transmission Electron MicroscopyUlrich BaxaPart IV Immunology9. Updated Method for In Vitro Analysis of Nanoparticle Hemolytic PropertiesBarry W. Neun, Anna N. Ilinskaya, and Marina A. Dobrovolskaia10. In Vitro Assessment of Nanoparticle Effects on Blood CoagulationTimothy M. Potter, Jamie C. Rodriguez, Barry W. Neun, Anna N. Ilinskaya, Edward Cedrone, and Marina A. Dobrovolskaia11. In Vitro Analysis of Nanoparticle Effects on the Zymosan Uptake by Phagocytic CellsTimothy M. Potter, Sarah L. Skoczen, Jamie C. Rodriguez, Barry W. Neun, Anna N. Ilinskaya, Edward Cedrone, and Marina A. Dobrovolskaia12. Assessing NLRP3 Inflammasome Activation by NanoparticlesBhawna Sharma, Christopher B. McLeland, Timothy M. Potter, Stephan T. Stern, and Pavan P. Adiseshaiah13. Analysis of Complement Activation by NanoparticlesBarry W. Neun, Anna A. Ilinskaya, and Marina A. Dobrovolskaia 14. Methods for Analysis of Nanoparticle Immunosuppressive Properties In Vitro and In VivoTimothy M. Potter, Barry W. Neun, and Marina A. Dobrovolskaia15. Analysis of Pro-Inflammatory Cytokine and Type II Interferon Induction by NanoparticlesTimothy M. Potter, Barry W. Neun, Jamie C. Rodriguez, Anna N. Ilinskaya, and Marina A. Dobrovolskaia 16. Analysis of Nanoparticle Adjuvant Properties In VivoBarry W. Neun and Marina A. Dobrovolskaia17. In Vitro and In Vivo Methods for Analysis of Nanoparticle Potential to Induce Delayed Type Hypersensitivity ReactionsTimothy M. Potter, Barry W. Neun, and Marina A. Dobrovolskaia18. Autophagy Monitoring Assay II: Imaging Autophagy Induction in LLC-PK1 Cells Using GFP-LC3 Protein Fusion ConstructPavan P. Adiseshaiah, Sarah L. Skoczen, Jamie C. Rodriguez, Timothy M. Potter, Krishna Kota, and Stephan T. SternPart V Drug Release and In Vivo Efficacy19. Improved Ultrafiltration Method to Measure Drug Release from Nanomedicines Utilizing a Stable Isotope TracerSarah L. Skoczen and Stephan T. Stern20. Designing an In Vivo Efficacy Study of Nanomedicines for Preclinical Tumor Growth InhibitionPavan P. Adiseshaiah and Stephan T. Stern.
  • (source: Nielsen Book Data)9781493973507 20171211
This second edition volume expands on the first edition by providing up-to-date protocols to characterize nanomaterials used as drug delivery agents. The chapters in this book are divided into 5 parts and cover topics such as: advances and obstacles in nanomedicine research; methods to test sterility and endotoxin, physicochemical features, immunological effects, drug release, and in vivo efficacy. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls.Cutting-edge and comprehensive, Characterization of Nanoparticles Intended for Drug Delivery, Second Edition is a valuable tool for researchers and pharmaceutical and biotechnology developers who are evaluating the clinical potential of nanomedicines in preclinical studies.>.
(source: Nielsen Book Data)9781493973507 20171211
1 online resource (391 p.) : ill. (some col.)
"With the alarming increase in cancer diagnoses and genetic illnesses, traditional drug agents and their delivery media need to be re-evaluated to address a quickly evolving field. With newer smart materials for the controlled release of macromolecules, peptides, genetic material, etc. further complications arise, such as material performance, synthesis, functionalization and targeting, biological identity, and biocompatibility. The book provides a comprehensive overview of the recent developments on "smart" targeting and drug delivery systems with a variety of carriers like nanoparticles, membranes, and hydrogels. It contains detailed descriptions on the recent trends in this field in the ongoing battle with catastrophic diseases like cancer. This field of research has been in its infancy and continues to face growth, and with it, further challenges and difficulties along the way toward maturity, which are accurately introduced in this book."-- Provided by publisher.
1 online resource.
pages ; [ca. 23-29] cm
  • Pharmacotherapy, Toxicodynamics and Regulatory Science-Divergent Objectives Nonclinical Pharmacokinetics - a primer Routes - with considerations for species specificity Delivery Systems Regimens Fundamentals of Nonclinical Formulation Excipients and Vehicles: Tolerance and toxicity Appendices.
  • (source: Nielsen Book Data)9781466502536 20171218
If we will ever achieve Paul Ehrlich's "magic bullet, " that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change. Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems seeks to address a trio of objectives that, though separate, are linked and central to biomedical science and, ultimately, medicine. Rather seeing these as separate "silos, " those working in nonclinical safety assessment will have to view these three in an integrated manner and to regularly and thoughtfully incorporate new information and technology. The trio of objectives this book explores are: first, to present how to deliver more of a drug product systemically to facilitate the regulatory need for evaluating safety and efficacy in animal species (at elevated exposure levels) prior to advancing the drug to human testing; second is to achieve better tolerance to therapeutics administration in test animals and humans which achieves objectives 1 and 3; and third, to explore ways to improve on therapeutic target receptor delivery performance, therefore improving both clinical pharmacodynamics bioavailability and specificity. The book's ten chapters assemble the basic concepts, principles and hypotheses involved in quantitative receptor and chronological organism interaction dynamics central to the successful development of new therapeutics which depend on systemic administration to achieve desired therapeutic goals and in so doing avoid outcomes which limit, marginalize, or preclude the therapeutic use of so many molecules.
(source: Nielsen Book Data)9781466502536 20171218
The concept of the perfect medicine as a molecule that goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body is especially relevant now. Much of the current costs and post-market safety concerns arise from the inability to achieve adequate concentrations and selectivity in the due course of actually delivering the active drug. Providing an integrated approach, this book presents ways of achieving the desired adequate and selective delivery using the currently available technology in three tool sets: route, regimen, and formulation.
(source: Nielsen Book Data)9781466502598 20171218
1 online resource.
Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries: Present Challenges and Future Solutions examines the particularities of low- and middle-income countries and offers solutions based on their needs, culture and available resources. Drawing from the firsthand experience of researchers and practitioners working in these countries, this book addresses the socio-behavioral aspects of pharmacy and health, pharmacoeconomics, pharmaceutical policy, supply management and marketing, pharmacoepidemiology and public health pharmacy specific to low- and middle-income countries. While some practices may be applied appropriately in disparate places, too often pharmacy practice in low- and middle-income countries is directly copied from successes in developed countries, despite the unique needs and challenges low- and middle-income countries face.
1 online resource (xvi, 294 pages) : illustrations (some color). Digital: text file; PDF.
  • Optocapacitance allows for photostimulation of neurons without requiring genetic modification / Joao L. Carvalho-de-Souza, Jeremy S. Treger, David R. Pepperberg, and Francisco Bezanilla
  • Nanoparticle-assisted localized optical stimulation of cultured neurons / Flavie Lavoie-Cardinal, Charleen Salesse, Pierre-Luc Ayotte-Nadeau, and Paul De Koninck
  • Stimulation of primary auditory neurons mediated by near-infrared excitation of gold nanorods / Chiara Paviolo, Karina Needham, William G.A. Brown, Jiawey Yong, and Paul R. Stoddart
  • Nanoparticle preparation for magnetothermal genetic stimulation in cell culture and in the brain of live rodents / Idoia Castellanos-Rubio, Rahul Munshi, Shahnaz Qadri, and Arnd Pralle
  • Genetically encoded nanoparticles for neural modulation / Sarah A. Stanley
  • Two applications of gold nanostars to hippocampal neuronal cells : localized photothermal ablation and stimulation of firing rate / Fidel Santamaria and Xomalin G. Peralta
  • Regulating growth cone motility and axon growth by manipulating targeted superparamagnetic nanoparticles / Tanchen Ren, Jeffrey L. Goldberg, and Michael B. Steketee
  • Assessment of the effects of a wireless neural stimulation mediated by piezoelectric nanoparticles / Attilio Marino, Satoshi Arai, Yanyan Hou, Mario Pellegrino, Barbara Mazzolai, Virgilio Mattoli, Madoka Suzuki, and Gianni Ciofani
  • Influence of external electrical stimulation on cellular uptake of gold nanoparticles / Samantha K. Franklin, Brandy Vincent, Sumeyra Tek, and Kelly L. Nash
  • Estimating the effects of nanoparticles on neuronal field potentials based on their effects on single neurons in vitro / Michael Busse, Narsis Salafzoon, Annette Kraegeloh, David R. Stevens, and Daniel J. Strauss
  • Application of in vivo extracellular recording technique to study the biological effects of nanoparticles in brain / Yanyan Miao, Han Zhao, Jutao Chen, Ming Wang, and Longping Wen
  • Using the whole cell patch clamp technique to study the effect of nanoparticles in hippocampal neurons / Xiaochen Zhang and Zhuo Yang
  • Comparative analysis of neurotoxic potential of synthesized, native, and physiological nanoparticles / Arsenii Borysov, Natalia Pozdnyakova, Artem Pastukhov, and Tatiana Borisova
  • Stoichiometrically defined neural coculture model to screen nanoparticles for neurological applications / Stuart I. Jenkins and Divya M. Chari
  • Long-term organism distribution of microwave hydrothermally synthesized ZrO2 : Pr nanoparticles / Jarosław Kaszewski, Paula Kiełbik, Anna Słońska-Zielonka, Izabela Serafińska, Jakub Nojszewski, Marek Godlewski, Zdzisław Gajewski, and Michał M. Godlewski
  • Gold nanoparticles as nucleation centers for amyloid fibrillation / Yanina D. Álvarez, Jesica V. Pellegrotti, and Fernando D. Stefani.
This volume discusses techniques to synthesize and functionalize nanoparticles, monitor their delivery and uptake, and identify and evaluate their lethal and non-lethal effects on the metabolic activity of the nervous system. The chapters in this book are divided into 4 sections: photo-stimulation, thermal stimulation, mechanical perturbation, and toxicity and physiological effects. The first 3 sections focus on nanoparticle interactions with external sources that disturb the neuronal system, while the 4th explores the effects of having nanoparticles in a neuronal system in the absence of external stimuli. In Neuromethods series style, chapters include the kind of detail and key advice from the specialists needed to get successful results in your laboratory. Cutting-edge and comprehensive, Use of Nanoparticles in Neuroscience is a valuable resource for graduate students and specialized researchers that want to learn techniques needed to quantify experiments that use nanoparticles in the nervous system.
(source: Nielsen Book Data)9781493975822 20180312
1 online resource.
  • List of Contributors xvii Preface xxi Historical Perspective: What Makes Antibody Drug Conjugates Revolutionary? xxiii Part I What is an Antibody Drug Conjugate 1 1 Typical Antibody Drug Conjugates 3 John M. Lambert 1.1 Introduction 3 1.2 The Building Blocks of a Typical ADC 6 1.3 Building an ADC Molecule 13 1.4 Attributes of a Typical ADC 19 1.5 Summary 24 Acknowledgment 24 Abbreviations 25 References 25 Part II Engineering, Manufacturing, and Optimizing Antibody Drug Conjugates 33 2 Selecting Optimal Antibody Drug Conjugate Targets Using Indication-Dependent or Indication-Independent Approaches 35 Jay Harper and Robert Hollingsworth 2.1 Characteristics of an Optimal ADC Target 35 2.2 Indication-Dependent ADC Target Selection 40 2.3 Indication-Independent ADC Target Selection 48 2.4 Concluding Remarks and Future Directions 50 Acknowledgments 52 References 52 3 Antibody Drug Conjugates: An Overview of the CMC and Characterization Process 59 Philip L. Ross and Janet Wolfe 3.1 Introduction 59 3.2 ADC Manufacturing Process 60 3.3 Characterization 70 3.4 Comparability 76 3.5 Concluding Remarks 76 Abbreviations 77 References 78 4 Linker and Conjugation Technology-- and Improvements 85 Riley Ennis and Sourav Sinha 4.1 Overview 85 4.2 Noncleavable 86 4.3 Cleavable Linkers and Self -Immolative Groups 86 4.4 Differences in Therapeutic Window of Cleavable and Noncleavable Linkers 88 4.5 Improving Therapeutic Window with Next -Generation Linker Technologies 89 4.6 Site -Specific Conjugation, Homogeneous Drug Species, and Therapeutic Window 91 4.7 Influence of Linkers on Pharmacokinetics and ADME 93 4.8 PEG Linkers to Optimize Clearance, Solubility, and Potency 93 4.9 Linkers to Optimize for Drug Resistance 94 4.10 Improving Solid Tumor Penetration with Linkers 96 4.11 Analytical Methods for Characterizing Linker Pharmacodynamics 96 4.12 Conclusion 98 References 99 5 Formulation and Stability 105 Kouhei Tsumoto, Anthony Young, and Satoshi Ohtake 5.1 Introduction 105 5.2 Stability Considerations for ADCs 106 5.3 Formulation Approaches 115 5.4 Logistical Considerations 123 5.5 Summary and Close 125 References 126 6 QC Assay Development 131 Xiao Hong. Chen and Mate Tolnay 6.1 Introduction 131 6.2 Drug -to -Antibody Ratio 132 6.3 Drug Loading Distribution 133 6.4 Positional Isomers 136 6.5 ADC Concentration 136 6.6 Drug -Related Substances 137 6.7 Antigen Binding Assays and Potential Impact of Drug Conjugation 137 6.8 Cell -Based Cytotoxicity Assays 139 6.9 Assays to Monitor Fc -Dependent Effector Functions to Characterize Additional Possible Mechanisms of Action 140 6.10 Immunogenicity Assays to Monitor the Immune Response to ADC 142 6.11 Conclusions 144 6.12 Key Guidance Documents 145 Acknowledgments 145 References 145 7 Occupational Health and Safety Aspects of ADCs and Their Toxic Payloads 151 Robert Sussman and John Farris 7.1 Introduction 151 7.2 Background on ADCs 152 7.3 Occupational Hazard Assessment of ADCs and Their Components 157 7.4 Occupational Implications and Uncertainties 159 7.5 General Guidance for Material Handling 160 7.6 Facility Features and Engineering Controls 163 7.7 Specific Operational Guidance 165 7.8 Personal Protective Equipment 167 7.9 Training 168 7.10 Industrial Hygiene Monitoring 169 7.11 Medical Surveillance Program 171 7.12 Summary and Future Direction 172 References 172 Part III Nonclinical Approaches 177 8 Bioanalytical Strategies Enabling Successful ADC Translation 179 Xiaogang Han, Steven Hansel, and Lindsay King 8.1 Introduction 179 8.2 ADC LC/MS Bioanalytical Strategies 182 8.3 Non -Regulated ADC Pharmacokinetic and Immunogenicity Support Using Ligand Binding Assays 190 8.4 Biodistribution Assessment 195 8.5 Regulated ADC Pharmacokinetics and Immunogenicity Evaluation 196 8.6 ADC Biomeasures and Biomarkers 199 8.7 Summary 200 References 201 9 Nonclinical Pharmacology and Mechanistic Modeling of Antibody Drug Conjugates in Support of Human Clinical Trials 207 Brian J. Schmidt, Chin Pan, Heather E. Vezina, Huadong Sun, Douglas D. Leipold, and Manish Gupta 9.1 Introduction 207 9.2 Cell Line Testing 210 9.3 Xenograft Models 214 9.4 Nonclinical Testing to Support Investigational New Drug Applications 216 9.5 Mechanistic Modeling of Antibody Drug Conjugates 220 9.6 Target -Mediated Toxicity of Antibody Drug Conjugates 228 9.7 Considerations for Nonclinical Testing Beyond Antibody Drug Conjugate Monotherapies 229 9.8 Summary 230 Acknowledgments 231 References 231 10 Pharmacokinetics of Antibody Drug Conjugates 245 Amrita V. Kamath 10.1 Introduction 245 10.2 Pharmacokinetic Characteristics of an ADC 246 10.3 Unique Considerations for ADC Pharmacokinetics 250 10.4 Tools to Characterize ADC PK/ADME 254 10.5 Utilization of ADC Pharmacokinetics to Optimize Design 257 10.6 Pharmacokinetics of Selected ADCs 259 10.7 Summary 261 References 262 11 Path to Market Approval: Regulatory Perspective of ADC Nonclinical Safety Assessments 267 M. Stacey Ricci, R. Angelo De Claro, and Natalie E. Simpson 11.1 Introduction 267 11.2 FDA Experience with ADCs 268 11.3 Regulatory Perspective of the Nonclinical Safety Assessment of ADCs 269 11.4 Concluding Remarks 282 References 283 Part IV Clinical Development and Current Status of Antibody Drug Conjugates 285 12 Antibody Drug Conjugates: Clinical Strategies and Applications 287 Heather E. Vezina, Lucy Lee, Brian J. Schmidt, and Manish Gupta 12.1 Antibody Drug Conjugates in Clinical Development 287 12.2 Therapeutic Indications 291 12.3 Transitioning from Discovery to Early Clinical Development 292 12.4 Challenges and Considerations in the Design of Phase 1 Studies 293 12.5 First-in-Human Starting Dose Estimation 293 12.6 Dosing Strategy Considerations 294 12.7 Dosing Regimen Optimization 295 12.8 Phase 1 Study Design 297 12.9 Supportive Strategies for Phase 1 and Beyond 299 12.10 Clinical Pharmacology Considerations 301 12.11 Organ Impairment Assessments 301 12.12 Drug Drug Interaction Assessments 302 12.13 Immunogenicity 303 12.14 QT/QTc Assessments 303 12.15 Pharmacometric Strategies 307 12.16 Using Physiologically Based Pharmacokinetic and Quantitative Systems Pharmacology Models with Clinical Data 308 12.17 Summary and Conclusions 311 Acknowledgments 311 References 311 13 Antibody Drug Conjugates (ADCs) in Clinical Development 321 Joseph McLaughlin and Patricia LoRusso 13.1 Introduction and Rationale 321 13.2 Components of ADCs in Development 321 13.3 Landscape of ADCs 329 13.4 Clinical Use of ADCs 330 13.5 Future of ADCs 330 13.6 ADCs in Development 330 13.7 Future Directions 340 References 340 14 ADCs Approved for Use: Trastuzumab Emtansine (Kadcyla(R), T-DM1) in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer 345 Gail D. Lewis Phillips, Sanne de Haas, Sandhya Girish, and Ellie Guardino 14.1 Introduction 345 14.2 Preclinical Development of T-DM1 348 14.3 Early Clinical Studies of T-DM1 357 14.4 Clinical Pharmacology and Pharmacokinetics 361 14.5 Phase III Studies of T-DM1 in Patients with HER2-Positive MBC 362 14.6 Future Directions 371 14.7 Summary 373 References 374 15 ADCs Approved for Use: Brentuximab Vedotin 381 Monica Mead and Sven de Vos 15.1 Introduction 381 15.2 Early Efforts to Target CD30 with Monoclonal Antibodies 383 15.3 BV: Preclinical Data 386 15.4 Clinical Context 394 15.5 Mechanisms of Resistance 395 15.6 Current Research 397 15.7 Discussion 400 References 401 16 Radioimmunotherapy 409 Savita V. Dandapani and Jeffrey Wong 16.1 History of Radioimmunotherapy 409 16.2 Radioisotopes 410 16.3 Chemistry of RIT 411 16.4 Radioimmunotherapy Antibody Targets in Use Today (Table 16.2) 412 16.5. Other Hematologic Targets 415 16.6 Solid Tumors 417 16.7 Combination Therapy with RIT: Chemotherapy and/or Radiation 420 16.8 RIT and External Beam Radiation Treatment (EBRT) 421 16.9 RIT and EBRT and Chemotherapy 421 16.10 RIT Administration 422 16.11 Future of RIT 422 References 423 Part V Future Perspectives in Antibody Drug Conjugate Development 431 17 Radiolabeled Antibody -Based Imaging in Clinical Oncology 433 Bart S. Hendriks and Daniel F. Gaddy 17.1 Introduction 433 17.2 Applications for Clinical Antibody Imaging 434 17.3 Antibodies as Imaging Agents 435 17.4 Nuclear Imaging Gamma Camera (Planar) Scintigraphy and SPECT 439 17.5 Nuclear Imaging - PET 448 17.6 Commercialization Considerations 456 17.7 Summary 461 References 462 18 Next-Generation Antibody Drug Conjugate Technologies 473 Amy Q. Han and William C. Olson 18.1 Introduction 473 18.2 Novel Cytotoxic Payloads and Linkers 474 18.3 Tailoring Antibodies for Use as ADCs 482 18.4 Conclusions 491 References 491 Index 505.
  • (source: Nielsen Book Data)9781119060680 20170313
Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging Includes case studies of ADCs in oncology drug development Features contributions from highly-regarded experts on the frontlines of ADC research and development.
(source: Nielsen Book Data)9781119060680 20170313
1 online resource (xvii, 291 pages)
  • List of Contributors 1. IntroductionDonald Huddler 2. Thermodynamics in Drug DiscoveryOBrienMarkova&Holdgate 3. Tailoring Hit Identification and Qualification Methods for Targeting Protein-Protein InteractionsBjorn Walse, Andrew P. Turnbull, Susan M. Boyd 4. HYDROGEN DEUTERIUM EXCHANGE MASS SPECTROMETRY IN DRUG DISCOVERYThorleif Lavold, Roman Zubarev and Juan Astorga-Wells 5. MICROSCALE THERMOPHORESIS IN DRUG DISCOVERYTanja Bartoschik, Melanie Maschberger, Alessandra Feoli, Timon Andre, Philipp Baaske, Stefan Duhr and Dennis Breitsprecher 6. SPR Screening Applying the new generation of SPR hardwareKartik Narayan and Steve Carroll 7. Weak Affinity Chromatography (WAC)Sten Ohlsonâ and Minh-Dao Duong-Thi 8. 1D NMR Methods for Hit IdentificationMary J Harner, Guille Metzler, Caroline A Fanslau, Luciano Mueller, William J Metzler 9. Protein-Based NMR Methods Applied to Drug DiscoveryAlessio Bortoluzzi, Alessio Ciulli 10. Applications of Ligand and Protein-observed NMR in DiscoveryIsabelle Krimm Conclusion 11. Using Biophysical Methods to Optimize Compound Residence TimeG. A. Holdgate, P. Rawlins, M. Bista, C. J. Stubbs 12. Applying biophysical and biochemical methods to the discovery of allosteric modulators of the AAA ATPase p97Stacie L. Bulfer and Michelle R. Arkin 13. Driving Drug Discovery with Biophysical Information Application to Staphylococcus aureus Dihydrofolate Reductase (DHFR)Parag Sahasrabudhe, Veerabahu Shanmugasundaram, Mark Flanagan, Kris A. Borzilleri, Holly Heaslet, Anil Rane, Alex McColl, Tim Subashi, George Karam, Ron Sarver, Melissa Harris, Boris A. Chrunyk, Chakrapani Subramanyam, Thomas V. Magee, Kelly Fahnoe, Brian Lacey, Henry Putz, J. Richard Miller, Jaehyun Cho, Arthur Palmer III and Jane M. Withka 14. Assembly of fragment screening libraries: Property and diversity analysisBradley C. Doak, Craig J. Morton, Jamie S. Simpson & Martin J. Scanlon Index.
  • (source: Nielsen Book Data)9781119099482 20170731
Applied Biophysics for Drug Discovery is a guide to new techniques and approaches to identifying and characterizing small molecules in early drug discovery. Biophysical methods are reasserting their utility in drug discovery and through a combination of the rise of fragment-based drug discovery and an increased focus on more nuanced characterisation of small molecule binding, these methods are playing an increasing role in discovery campaigns. This text emphasizes practical considerations for selecting and deploying core biophysical method, including but not limited to ITC, SPR, and both ligand-detected and protein-detected NMR. Topics covered include: Design considerations in biophysical-based lead screening Thermodynamic characterization of protein-compound interactions Characterizing targets and screening reagents with HDX-MS Microscale thermophoresis methods (MST) Screening with Weak Affinity Chromatography Methods to assess compound residence time 1D-NMR methods for hit identification Protein-based NMR methods for SAR development Industry case studies integrating multiple biophysical methods This text is ideal for academic investigators and industry scientists planning hit characterization campaigns or designing and optimizing screening strategies.
(source: Nielsen Book Data)9781119099482 20170731
xiii, 290 pages, 32 unnumbered pages of plates : color illustrations, map ; 24 cm.
For more than one thousand years Arab medicine held sway in the ancient world, from the shores of Spain in the West to China, India and Sri Lanka (Ceylon) in the East. This book explores the impact of Greek (as well as Indian and Persian) medical heritage on the evolution of Arab medicine and pharmacology, investigating it from the perspective of materia medica - a reliable indication of the contribution of this medical legacy. Focusing on the main substances introduced and traded by the Arabs in the medieval Mediterranean - including Ambergris, camphor, musk, myrobalan, nutmeg, sandalwood and turmeric - the authors show how they enriched the existing inventory of drugs influenced by Galenic-Arab pharmacology. Further, they look at how these substances merged with the development and distribution of new technologies and industries that evolved in the Middle Ages such as textiles, paper, dyeing and tanning, and with the new trends, demands and fashions regarding spices, perfumes, ornaments (gemstones) and foodstuffs some of which can be found in our modern-day food basket.
(source: Nielsen Book Data)9780748697816 20170313
Green Library
xx, 248 pages : color illustrations ; [ca. 23-29] cm.
  • Biosimilars for Drug Development. Regulatory Requirements on Biosimilars. System Biology in the Context of Biosimilars. Clinical Considerations on Biosimilars. Large Molecules Complete Molecular Confidence (CMC) Development Strategy. Immunogenicity. Interchangeability. Bridging a New Biologic to Its Reference Biologic. How to Account Covariate Effect to Show Non-Inferiority in Biosimilars. Novel Method in Inference of Equivalence in Biosimilars. Multiplicity Adjustment in Equivalence Using Two One-Sided Tests. Bayesian Methods in Biosimilar Studies.
  • (source: Nielsen Book Data)9781482231694 20171218
Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.
(source: Nielsen Book Data)9781482231694 20171218
online resource (19 pages) : color illustrations, charts
  • Background
  • Roadmap
  • The Cost Savings Potential of Biosimilars
  • An Evolving Market
  • Prior Cost Savings Estimates
  • The Need for Updated Cost Savings Estimates
  • Recent Literature on Biosimilar Cost Savings
  • Calculating an Updated Estimate of Biosimilar Cost Savings
  • Limitations of Our Cost Savings Estimate
  • Who Will Benefit from Biosimilar Cost Savings?
  • The Future of the U.S. Biosimilars Market
  • Is Policy Change Necessary?
  • Conclusion
  • Notes.
"The Biologics Price Competition and Innovation Act (BPCIA), enacted as part of the 2010 Patient Protection and Affordable Care Act (ACA), authorized the U.S. Food and Drug Administration (FDA) to create a new regulatory approval pathway for biosimilars, which are biologic drugs that are very similar to already approved "reference" biologics in terms of potency, safety, and efficacy, but are manufactured by different companies. In the seven years since the ACA, many drug manufacturers worked to push new biosimilars through development and FDA review. As of July 2017, there were three marketed biosimilars and two more that were approved by the FDA but not yet marketed. BPCIA's shorter, lower-cost biosimilar approval pathway was designed to introduce competition among biologic manufacturers. This Perspective estimates potential future savings from biosimilars in the United States, summarizes the experience to date with the first marketed biosimilar in the United States, and discusses key policy issues surrounding biosimilars. We estimate that biosimilars will reduce direct spending on biologic drugs by $54 billion from 2017 to 2026, or about 3 percent of total estimated biologic spending over the same period, with a range of $24 to $150 billion. While our estimate uses recent data and transparent assumptions, we caution that actual savings will hinge on industry and regulatory decisions as well as potential policy changes to strengthen the biosimilar market"--Publisher's description.
Medical Library (Lane)
xiv, 596 pages : illustrations ; [ca. 23-29] cm
  • Chapter 1: Basic Concepts in Drug Targeting Chapter 2: Biological Targets: Identification, Selection and Validation Chapter 3: Emerging Therapeutic Targets for Diabetes Chapter 4: Prodrug Strategy: An Effective Tool in Drug Delivery and Targeting Chapter 5: Drug Targeting Strategies to CNS Disorders Chapter 6: Natural Polymers in Colon Targeting: Approaches and Future Perspectives Chapter 7: Lymphatic Drug Targeting Chapter 8: New Drug Targets and Drug Delivery Strategies for Various Ocular Disorders Chapter 9: Bone Target Drug Delivery Systems Chapter 10: Targeted Drug Delivery in Solid Tumours: An Overview and Novel Approaches for Therapy Chapter 11: Mitochondria as an Emerging Target for the Delivery of Small Therapeutic Molecules Chapter 12: Antisense Oligonucleotide-Mediated Target Specific Gene Silencing: Design, Delivery Strategies and Therapeutic Applications Chapter 13: Biodegradable Polymeric Carriers for Delivery of siRNA Chapter 14: Organic-Inorganic Nanocomposites for Biomedical Applications Chapter 15: Carbon Nanotube Induced Targeted Drug Delivery Chapter 16: Functionalized Cyclodextrin: A Versatile Supramolecular Systems for Drug Delivery Chapter 17: Nanopolymer Scaffolds as Novel Carriers for Cells and Drugs Chapter 18: Biotargets for Polyionic Glucan Derivatives and their Nano-Therapeutic Systems Chapter 19: Novel Carriers for Targeted Delivery of Herbal Medicines Chapter 20: Toxicological Concerns Related to Nanoscale Drug Delivery Systems.
  • (source: Nielsen Book Data)9781498730006 20171218
The advances in drug delivery systems over recent years have resulted in a large number of novel delivery systems with the potential to revolutionize the treatment and prevention of diseases. Bio-Targets and Drug Delivery Approaches is an easy-to-read book for students, researchers and pharmaceutical scientists providing a comprehensive introduction to the principles of advanced drug delivery and targeting their current applications and potential future developments.
(source: Nielsen Book Data)9781498730006 20171218
1 online resource ( xv, 328 pages) : illustrations (some color).
  • Chapter 1 Medicinal Plants: Ethno-Uses to Biotechnology Era.- Chapter 2 How Plants Can Contribute to the Supply of Anti-Cancer Compounds.- Chapter 3 Cancer and Biotechnology: A Matchup that Should Never Slowdown.- Chapter 4 Plant Derived Compounds with Anti-Cancer Properties: From Folklore to Practice.- Chapter 5 Anticancer Drugs from Plants.- Chapter 6 Cambial Meristematic Cells: A Sustainable Platform for the Production of Plant-Derived Anti-Cancer Crugs.- Chapter 7 Family Fabaceae: A Boon for Cancer Therapy.- Chapter 8 Small Cells For Big Ideas: The Cytotoxic Podophyllotoxin And The Long Journey In Discovering Its Biosynthetic Pathway.- Chapter 9 Hairy Root Culture for the Production of Useful Secondary Metabolites.- Chapter 10 Edible Mushrooms and Their In Vitro Culture as a Source of Anticancer Compounds.- Chapter 11 Genomics and Artificial Intelligence Working Together in Drugs Discovery and Repositioning: The Advent of Adaptive Pharmacogenomics in Glioblastoma and Chronic Arterial Inflammation Therapies.- Chapter 12 A Multiscale Haemorheological Computer-based Model of Chronic Inflammation: an in-Depth Investigation of Erythrocytes-driven Flow Characteristics in Atheroma Development.
  • (source: Nielsen Book Data)9783319538792 20170821
This book discusses cancers and the resurgence of public interest in plant-based and herbal drugs. It also describes ways of obtaining anti-cancer drugs from plants and improving their production using biotechnological techniques. It presents methods such as cell culture, shoot and root culture, hairy root culture, purification of plant raw materials, genetic engineering, optimization of culture conditions as well as metabolic engineering with examples of successes like taxol, shikonin, ingenol mebutate and podophylotoxin. In addition, it describes the applications and limitations of large-scale production of anti-cancer compounds using biotechnological means. Lastly, it discusses future economical and eco-friendly strategies for obtaining anti-cancer compounds using biotechnology.
(source: Nielsen Book Data)9783319538792 20170821
ProQuest Ebook Central Access limited to 1 user
ix, 806 pages : color illustrations, color maps ; 30 cm
This is the first botanically authoritative and practical illustrated identification guide to Chinese medicinal plants and drugs and their substitutes. It offers authoritative guidance on the identification of the herbal drugs themselves, and the plants from which they are sourced. Over the past 15 years, the authors have been collecting plant specimens throughout China, using verified species to create typical TCM reference drugs, prepared according to traditional methods. The herbal drugs included in this book are officially recognised from the Chinese materia medica (as defined in the Chinese Pharmacopoeia) and their selection has been based on those popular in international trade, as well as those recognised by the European Herbal and Traditional Medicine Practitioners Association, and those that are easily confused, substituted or adulterated with other plants.
(source: Nielsen Book Data)9781842463871 20170717
Science Library (Li and Ma)
1 online resource ( viii, 87 pages.) :.
  • Introduction Networks and Pathways in Systems Pharmacology Time Varying Methods for Pathway and Sub-Pathway Analysis Identification of Differentially Expressed Pathways and Sub-Pathways.
  • (source: Nielsen Book Data)9783319538679 20170821
This work offers a guided walkthrough of one of the most promising research areas in modern life sciences, enabling a deeper understanding of involved concepts and methodologies via an interdisciplinary view, focusing on both well-established approaches and cutting-edge research. Highlighting what pathway analysis can offer to both the experimentalist and the modeler, the text opens with an introduction to a general methodology that outlines common workflows shared by several methods. This is followed by a review of pathway and sub-pathway based approaches for systems pharmacology. The work then presents an overview of pathway analysis methods developed to model the temporal aspects of drug- or disease-induced perturbations and extract relevant dynamic themes. The text concludes by discussing several state-of-the-art methods in pathway analysis, which address the important problem of identifying differentially expressed pathways and sub-pathways.
(source: Nielsen Book Data)9783319538679 20170821
ProQuest Ebook Central Access limited to 1 user
1 online resource : text file, PDF
  • PART-A: INDUSTRIAL ASPECTS OF PHYTOMEDICINE Introduction to Phytomedicine Phytopharmacovigilance Phytopharmacoeconomics Phytopharmacoepidemiology Phytopharmacogenomics Ethics in Phytomedicine Herbosomes Nanophytomedicine Metabolomics and Phytomedicine Clinical Research in Ayurveda Excepients for Phytomedicine Certifications for Phytodrug Industry Dhsea Acts Related to Banned or Restricted Phyto Ingredients Comfrey Based Herbal Products Herbal Bioenhancers PART-B: BIOACTIVES FROM PHYTOMEDICINE Phytosteroids and Related Compounds Botany of Phytosteroids Containing Medicinal Plants Pharmacology of BETA-Sitosterol and Other Sterols Pharmacology of Disogenin and Related Compounds Steroidal Alkaloids Guggulsterones Phytoecdysteroids Botany of Withanolides Containing Medicinal Plants Pharmacology of Withaferin A Pharmacology of Withanolide A Pharmacology of Withanone Pharmacology of Withanolide D Miscellaneous Withanolides Sitoindosides Pyrrolizidine Alkaloids Phytocannabinoids Wild Cannabis Annexures (1-9) Related to Herbal Drug Registration Acronyms and Abbreviations Definitions Herbal Glossary.
  • (source: Nielsen Book Data)9781498773553 20171218
The term phytomedicine was coined by French physician Henri Leclerc in 1913. Till recently phytomedicine has remained in the background. But due to emerging challenges to the conventional pharmaceutical industry (cost effectiveness and potency of the drugs), phytomedicine has made a dramatic comeback. Phytomedicine has witnessed several changes and several new concepts have been introduced. Phytomedicine, although, a separate discipline, is strongly linked to Phytotherapy and Phytopharmacology. As the title suggests the book is an attempt to bridge the gap between fundamental and emerging concepts in this field of medicine. The book has been divided into two parts. Part A deals with core issues of the phyto-pharmaceutical drug industry. The book begins with an introductory chapter dealing with basic definitions with phytomedicine. Chapters 2-5 narrate emerging subjects such as Phytopharmacovigilance, Phytopharmacoeconomics, Phytopharmacoepidemiology and Phytopharmacogenomics. Chapter 6 discusses ethical issues in phytomedicine. Chapter 7 covers recent advances in drug delivery systems in phytomedicine whereas Chapter 8 is about application of nanotechnology in the field of phytomedicine. The further chapters cover metabolomics, regulatory and legal aspects of the phyto-pharmaceutical drug industry. The chapter on herbal bioavailability enhancing agents is the salient feature of Part-A. Part B is related to applied research in the field of phytomedicine. Experimental findings on phyto-bioactive agents such as withanolides, steroidal alkaloids, phytosteroids and phytocannabinoids have been elaborated. Nine annexures related to herbal drug registration are included.
(source: Nielsen Book Data)9781498773553 20171218
1 online resource (xxviii, 599 pages).
  • List of Contributors Preface Chapter 1 1.1 Introduction 1.2 Advantages of Continuous Manufacturing 1.3 Engineering Principles of Continuous Manufacturing Chapter 2 2.1 Introduction 2.2 Pharmaceutical solid dosage manufacturing processes 2.3 Mathematical modeling approaches 2.4 Unit operations models 2.5 Process control of continuous solid-based drug manufacturing 2.6 Summary 2.7 References Chapter 3 3.1 Introduction 3.2 Regulatory considerations 3.3 Quality/GMP considerations 3.4 Quality considerations for bridging existing batch manufacturing to continuous manufacturing 3.5 General regulatory references Chapter 4 4.1 Introduction 4.2 Micro Flow Technology 4.3 Multi-step synthesis of active pharmaceutical ingredients in micro flow 4.4 Larger scale syntheses 4.5 Current industrial applications 4.6 Conclusion and Outlook 4.7 References Chapter 5 5.1 Introduction 5.2. Principles of Crystallisation 5.3 Crystallisation Process Development 5.4 Continuous Crystallisers and Applications 5.5 Process Monitoring, Analysis and Control 5.6 Particle Characterisation 5.7 Concluding Remarks Chapter 6 6.1 Abstract 6.2 Introduction 6.3 Operation of fermentation systems 6.4 Continuous fermentation examples 6.5 Discussion 6.6 Conclusion 6.7 References Chapter 7 7.1. Background 7.2. Continuous upstream processing 7.3. Continuous downstream processing 7.4. Process integration and single use technology 7.5. Process monitoring and control 7.6. Process economics of continuous manufacturing 7.7. Conclusions 7.8. Acknowledgements 7.9. References Chapter 8 8.1 Introduction 8.2 Continuous wet-granulation using TSG 8.3 Components of high shear wet granulation in TSG 8.4 Material transport and mixing in a TSG 8.5 Granule size evolution during twin-screw granulation 8.6 Model-based analysis of twin-screw granulation 8.7 Towards generic twin-screw granulation knowledge 8.8 Strengths and limitations of TSG studies Chapter 9 9.1 Roller compaction 9.2 Main components of a roller compactor 9.3 Theory of powder densification in roller compaction 9.4 Experimental observations of pressure distribution from instrumented roller compactors 9.5 Off-line characterization of ribbon quality 9.6 In-line monitoring of roller compaction process 9.7 Formulative aspects of roller compaction 9.8 Roller compaction as a unit operation in continuous manufacturing 9.9 Process control of continuous roller compaction 9.10 Conclusions 9.11 References Chapter 10 10.1 Introduction 10.2 The Extruder 10.3 Feeding 10.4 Twin-screw extrusion 10.5 Operation Point 10.6 Downstream Processing 10.7 Continuous manufacturing with hot melt extrusion 10.8 Process Analytical Technology for hot melt extrusion 10.9 Process Integration into Computerized Systems 10.10 Conclusion 10.11 References Chapter 11 11.1 Industry Drivers for Continuous Processing: Competitive Advantages 11.2 Continuous Manufacturing in Bioprocessing 11.3 Continuous Manufacturing for Oral Solid Dosage Forms 11.4 The Pharmaceutical Supply Chain of the Future 11.5 Discussion 11.6 Conclusion Chapter 12 12.1 Introduction 12.2 Rough conceptual design 12.3 Material property screening 12.4 Characterizing Unit Operation using Actual Process Materials 12.5 Develop and Calibrate Unit Operation Models Including Process Materials 12.6 Develop an Integrated Model of an Open Loop System 12.7 Examine Open Loop Performance of the Process 12.8 Develop/fine tune PAT methods for appropriate unit ops 12.9 Implement open loop kit with PAT and IPCs enabled 12.10 Design of the control architecture 12.11 Develop integrated model of closed loop system 12.12 Implementation and Verification of the Control Framework 12.13 Characterize and verify closed performance 12.14 Conclusions Chapter 13 13.1 Introduction 13.2 Process Description 13.3 System Dynamics 13.4 Process Monitoring and Control 13.5 Outlook: opportunities for novel unit operations and system configurations 13.6 Summary and closing thoughts 13.7 References Chapter 14 14.1 Introduction 14.2 Technical-economic evaluation methodology 14.3 Conclusion Chapter 15 15.1 Introduction 15.2 Personalized Medicine 15.3 Flexible Dosing with Innovative Products 15.4 Future Health Care Scenario 15.5 References Chapter 16 16.1 Introduction 16.2 Inkjet (microdrop generation techniques) 16.3 Flexographic printing 16.4 Formulation approaches for inkjet and flexography 16.5 Process Control and Process Analytical Technology for continuous printing applications 16.6 From the lab-scale printing towards an industrial scale 16.7 3D printing/Additive manufacturing 16.8 References Chapter 17 17.1 Introduction 17.2 Background 17.3 Goals for the LDT program 17.4 Overview of liquid dispensing technology 17.5 LDT machine design details 17.6 Scale-Independence of the LDT Technology 17.7 Real-Time Release Potential 17.8 Occupational Health, Environmental and Cleaning Considerations 17.9 Conclusion 17.10 Acknowledgements REFERENCES Index.
  • (source: Nielsen Book Data)9781119001324 20170731
A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processingCovers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-designContains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutionsOffers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.
(source: Nielsen Book Data)9781119001324 20170731
350 pages : illustrations ; 23 cm.
East Asia Library
p. ; [ca. 23-29] cm
  • Chapter 1: An Introduction of Key Concepts in Drug Delivery Steven Kuperberg, M.D., Mahyar Pourriahi, M.D., Jonathan Daich, M.D., Aaron Richler, M.D, Pablo Gurman, M.D., Noel M. Elman, PhD, and Yitzhak Rosen, M.D. Chapter 2: An Introduction to Pharmacokinetics: From Conventional to Advanced Systemic Drug Delivery Systems Alan Talevi, Luis Bruno Blanch, and Guillermo R. Castro Chapter 3: Transporters and Enzymes Targeted Prodrugs for Improved Oral Drug Delivery Arik Dahan and Shimon Ben-Shabat Chapter 4: Gastroretentive Delivery: Physicochemical, Biopharmaceutical, Technological and Regulatory Considerations Vivek K. Pawar, Yuvraj Singh, Mohini Chaurasia, and Manish K. Chourasia Chapter 5: Invasive vs. Non-Invasive Delivery of Insulin Sandra Soares, Ana Costa, Pedro Fonte, and Bruno Sarmento Chapter 6: Artificial Pancreas Drug Delivery Howard Zisser, MD, Jennifer Lane, Joseph Shivers Chapter 7: Micro/Nano Devices for Drug Delivery R. Sheybani and E. Meng Chapter 8: Microneedle-Mediated Vaccines Ryan F. Donnelly, Maeliosa T.C. McCrudden, Sharifa Al-Zahrani, and Steven J. Fallows Chapter 9: Application of Nanoparticle Tracking Analysis in Drug Delivery Mathew Wright Chapter 10: Microsponges for Drug Delivery Rishabh Srivastava Chapter 11: Chitosan for Advancing Drug Delivery Sanjay K. Jain and Satish Shilpi Chapter 12: Gene Delivery by Electroporation Julie Gehl Chapter 13: Drug Delivery Systems for Infectious Diseases Maximiliano L. Cacicedo, German A. Islan, Pablo Gurman, and Guillermo R. Castro Chapter 14: Nanotechnology in Drug Delivery to Chronic Inflammatory Diseases Mazen El-Hammadi and Jose L. Arias Chapter 15: Intrathecal Drug Delivery Krish Chan Chapter 16: Cancer Stem Cell Drug Delivery Masturah Bte Mohd Abdul Rashid, Lissa Nurrul Abdullah, Tan Boon Toh, and Edward Kai-Hua Chow Chapter 17: Cardiac Drug Delivery Paula Diaz-Herraez, Simon Pascual-Gil de Gomez, Elisa Garbayo, Teresa Simon-Yarza, Felipe Prosper, and Maria J. Blanco-Prieto Chapter 18: Current Developments in Nano-Therapeutics for Airway Diseases Indrajit Roy, Ridhima Juneja, Komal Sethi, and Neeraj Vij Chapter 19: Intravitreal Drug Delivery Omar Saleh M.D., Mark Ihnen, M.D., and Shlomit Schaal M.D., Ph.D Chapter 20: Drug Delivery in Obstetrics and Gynecology David Shveiky, M.D., Yael Hants, M.D., and Sarit Helman, M.D. Chapter 21: Drug Delivery Systems: A Regulatory Perspective Pablo Gurman, MD, Noel M. Elman, PhD, and Yitzhak Rosen, MD.
  • (source: Nielsen Book Data)9781466565944 20171218
Integrating the clinical and engineering aspects of drug delivery, this book offers a much needed comprehensive overview and patient-oriented approach for enhanced drug delivery optimization and advancement. Starting with an introduction to the subject and pharmacokinetics, it explores advances for such topics as oral, gastroretentive, intravitreal, and intrathecal drug delivery, as well as insulin delivery, gene delivery, and biomaterials-based delivery systems. It also describes drug delivery in cancer, cardiac, infectious diseases, airway diseases, and obstetrics and gynecology applications. Examining special clinical states requiring innovative drug delivery modifications, such as hypercoagulability often seen in pregnancy, cancer, and autoimmune diseases, the book also discusses methods for improved drug delivery in clinical settings using clinical end points, clinical trials, simulations, and other venues. It also describes the latest drug delivery advances involving nanomaterials, NEMS and MEMS devices, hydrogels, microencapsulation, lipids, stem cells, patches, and ultrasound. The book is rounded out by a chapter on the FDA regulatory and bioethical challenges involved in advancing drug delivery.
(source: Nielsen Book Data)9781466565944 20171218
1 online resource (172 pages)
Preceptor development is a topic rarely covered in pharmacy education, although pharmacists across the country are routinely asked to give back to their profession by precepting student and resident learners. Resources exist to help preceptors gain the skills and understand the theories of experiential education, but they are scattered across numerous sources, presented in an academic tone, or not comprehensive in nature. As such, the quality of precepting can vary significantly from practitioner to practitioner.Designed to serve as a user's guide for new and experienced preceptors of both residents and experiential students, The Effective Pharmacy Preceptor offers insight to common precepting scenarios and is organized by the timeline and tasks associated with a resident or student's experience.
(source: Nielsen Book Data)9781585285549 20180129