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xx, 274 p. : ill.
  • In Vitro Drug Release Behavior from a Novel Thermosensitive Composite Hydrogel Based on Pluronic F127 and Poly(Ethylene Glycol)-Poly( -Caprolactone)-Poly(Ethylene Glycol) Copolymer Hydroxycamptothecin-Loaded Nanoparticles Enhance Target Drug Delivery and Anticancer Effect Pharmaceutical Induction of ApoE Secretion by Multipotent Mesenchymal Stromal Cells (MSCs) Killing Cancer Cells by Targeted Drug-Carrying Phage Nanomedicines Inhibition of Cell Growth and Invasion by Epidermal Growth Factor-Targeted Phagemid Particles Carrying Sirna Against Focal Adhesion Kinase in the Presence of Hydroxycamptothecin Post-Marketing Assessment of Content and Efficacy of Preservatives in Artemisinin-Derived Antimalarial Dry Suspensions for Paediatric Use Adenovirus Dodecahedron, as a Drug Delivery Vector Nanopolymers Improve Delivery of Exon Skipping Oligonucleotides and Concomitant Dystrophin Expression in Skeletal Muscle of mdx Mice Synthesis of PET-PLA/Drug Nanoparticles and Their Effect with Gold Nanoparticles for Controlled Drug Release in Cancer Chemotherapy Nanotechnology Approaches to Crossing the Blood-Brain Barrier and Drug Delivery to the CNS Quantum Dot Imaging for Embryonic Stem Cells Cationic Nanoparticles for Delivery of Amphotericin B: Preparation, Characterization and Activity In Vitro Raft-Dependent Endocytosis of Autocrine Motility Factor/Phosphoglucose Isomerase: A Potential Drug Delivery Route for Tumor Cells Nanotechnology-Based Drug Delivery Systems Novel Multi-Component Nanopharmaceuticals Derived from Poly(Ethylene) Glycol, Retro-Inverso-Tat Nonapeptide and Saquinavir Demonstrate Combined Anti-HIV Effects Nanoporous Platforms for Cellular Sensing and Delivery Skin Permeation Mechanism and Bioavailability Enhancement of Celecoxib from Transdermally Applied Nanoemulsion.
  • (source: Nielsen Book Data)9781926692685 20160608
Pharmaceutical technology deals with the discovery, production, processing, and safe and effective delivery of medications to patients. Technologies involved include computer modeling for research, bioengineering for research instrumentation, processes and methods for increasing production, and computing technology and biosystematics for the management and analysis of data. This new book covers a wide range of important topics on today's pharmaceutical technology, such as in vitro drug release and controlled drug delivery, the use of nanotechnology in pharmaceuticals, quantum dot imaging, assessment and efficacy of pharmaceuticals, and much more.
(source: Nielsen Book Data)9781926692685 20160608
xxvi, 406 p. : ill. (some col.)
  • Preface XIX List of Contributors XXIII 1 Introduction to Sample Management 1 William P. Janzen and Andy Zaayenga References 6 2 Generating a High-Quality Compound Collection 9 Philip B. Cox and Anil Vasudevan 2.1 Defining Current Screening Collections 9 2.2 Design Criteria for Enriching a Compound Collection with Drug-Like Compounds 10 2.3 Concluding Remarks 20 References 20 3 Assessing Compound Quality 23 Ioana Popa-Burke, Stephen Besley, and Zoe Blaxill 3.1 Introduction 23 3.2 Process Quality and Analytical Quality in Compound Management 24 3.3 Identity 28 3.4 Purity/Stability 32 3.5 Concentration/Solubility 39 3.6 Conclusions 41 Acknowledgments 41 References 42 Further Reading 44 4 Delivering and Maintaining Quality within Compound Management 45 Isabel Charles 4.1 Introduction 45 4.2 What is Quality from a Compound Management Perspective? 46 4.3 Storage and Delivery of Samples in Solution 47 4.4 Intercepting Low Purity 49 4.5 Storage and Delivery of Solids 51 4.6 Automation Quality Control and Reliability 52 4.7 High-Quality Data Management 54 4.8 Conclusion 55 Acknowledgments 56 References 56 5 Obtaining and Maintaining High-Quality Tissue Samples: Scientific and Technical Considerations to Promote Evidence-Based Biobanking Practice (EBBP) 59 Lisa B. Miranda 5.1 Introduction 59 5.2 The Path toward Integration of Evidence-based Biobanking Practice 62 5.3 Integrating Evidence-based Biobanking Practice into Sample Protocols 66 5.4 Final Thoughts and Recommendations 74 References 79 6 Thinking Lean in Compound Management Laboratories 83 Michael Allen 6.1 The Emergence of 'Lean Thinking' 83 6.2 The Application of 'Lean Thinking' 83 6.3 Lean Thinking in Drug Discovery 86 6.4 A Lean Laboratory Toolbox 87 6.5 Streamlining Compound Processing -An Example 101 6.6 Summary 103 References 105 7 Application of Supply Management Principles in Sample Management 107 Paul A. Gosnell 7.1 Introduction 107 7.2 Common Pitfalls of Sample Management 107 7.2.1 One Size Does Not Fit All 108 7.3 Sample Management and Supply Chain Concepts 108 7.4 Implementing the Sample Management Strategy 111 7.5 Sample Management Organization 111 7.6 Sample Management Informatics 113 7.7 Avoid Monolithic Silos of Excellence 114 7.8 Position and Synchronize Inventory 115 7.9 Expand the Sample Management Boundary 117 7.10 Measuring and Assessing Effectiveness and Quality 118 7.11 Conclusions 119 References 120 8 Solid Sample Weighing and Distribution 121 Michael Gray and Snehal Bhatt 8.1 The Practicalities and Technology of Weighing Solid Compounds 121 8.2 Logistical Challenges of Transportation of Small Molecules 127 References 142 9 Managing a Global Biological Resource of Cells and Cellular Derivatives 143 Frank P. Simione and Raymond H. Cypess 9.1 Introduction 143 9.2 Diversity of Collections 144 9.3 Sourcing and Acquisition 148 9.4 Authentication and Characterization 149 9.5 Cryopreservation, Storage, and Production 153 9.6 Data Management 154 9.7 Quality and Standards 155 9.8 Order Fulfillment and Distribution 157 9.9 Offsite Biorepository Management 158 9.10 Regulatory and Legal Compliance 159 9.11 Ownership and Intellectual Property Management 160 9.12 Collaborations 161 9.13 Conclusion 162 References 163 10 Development of Automation in Sample Management 165 Gregory J. Wendel 10.1 Introduction 165 10.2 Historical Background 165 10.3 Automation of Sample Management Today 167 10.4 System Building Blocks 169 10.5 Storage Systems 171 10.6 Liquid Handler 175 10.7 Accessories 180 10.8 Plate Handling, Integration 184 10.9 Case Study: Evolution of a Compound Management Group 186 10.10 Results 196 References 197 11 Applications of Acoustic Technology 199 Eric Tang, Colin Bath, and Sue Holland-Crimmin 11.1 Introduction 199 11.2 Compound-Handling Challenges in Drug Discovery 201 11.3 Acoustic Drop Ejection -Performance, Quality Assurance, and Platform Validation 203 11.4 Acoustic-Assisted Compound Solubilization and Mixing 206 11.5 Acoustic Applications in Drug Discovery 209 11.6 Emerging Applications 216 References 218 12 Enhancing Biorepository Sample Integrity with Automated Storage and Retrieval 221 Johann van Niekerk 12.1 The Emerging Growth of Biobanking 221 12.2 Automated Storage and Retrieval in a Biorepository 225 12.3 Configuration of an Automated Biorepository 236 12.4 Conclusions 241 References 241 13 Information Technology Systems for Sample Management 243 Brian Brooks 13.1 Sample Registration 243 13.2 Intellectual Property and Laboratory Notebooks 253 13.3 Some Observations on Information Technology 254 13.4 Biological Data Management 255 Dedication and Acknowledgments 263 14 Key Features of a Compound Management System 265 Clive Battle 14.1 Why Do We Need Compound Management Information Technology Systems? 265 14.2 Compound Management Software 266 14.3 Benefits of Commercially Available Compound Management Systems 272 References 273 15 What Does an HTS File of the Future Look Like? 275 Francois Bertelli 15.1 Introduction 275 15.2 History of Compounds Collection for HTS 276 15.3 Impact of High-Throughput Chemistry on Corporate Files 277 15.4 Chemical Library Management 278 15.5 The Concept of Drug-Likeness and the Lipinski Rules 279 15.6 Quality versus Quantity 283 15.7 The Emergence of the Subsets: Fragment, G-Protein-Coupled Receptor (GPCR), Ion Channel, Kinase, Protein-Protein Interaction, Chemogenomics, Library Of Pharmacologically Active Compounds (LOPAC), Central Nervous System (CNS), and Diversity 285 15.8 Re-designing the Corporate File for the Future 291 15.9 Future Routes for Hit Identification 299 References 301 16 New Enabling Technology 305 Neil Hardy, Ji Yi Khoo, Shoufeng Yang, Holger Eickhoff, Joe Olechno, and Richard Ellson 16.1 Introduction 305 16.2 A Drop-On-Demand Printer for Dry Powder Dispensing 307 16.3 Piezo Dispense Pens: Integrated Storage and Dispensing Devices and their Potential in Secondary Screening and Diagnostic Manufacturing 312 16.4 Future Directions in Acoustic Droplet Ejection Technology 323 16.5 Closing Remarks 347 References 347 17 The Impact of Future Technologies within Biobanking 351 Manuel M. Morente, Laura Cereceda, and Mar'ia J. Artiga 17.1 Introduction 351 17.2 The Role of Biobanks in Biomedical Research 351 17.3 The Increasing Complexity of Biobanking 354 17.4 Future Technologies and Biobanking: How Could New Technologies Affect the Daily Activities of Biobanks? 356 17.5 The Future of Biobanking Does Not Depend on Technological Developments Alone 363 17.6 Conclusions 364 Acknowledgments 364 References 364 18 Outsourcing Sample Management 367 Sylviane Boucharens and Amelia Wall Warner 18.1 Outsourcing in the Pharmaceutical Industry 367 18.2 Outsourcing Biological Specimen Collections 374 18.3 Conclusions 378 Acknowledgments 378 References 378 19 Sample Management Yesterday and Tomorrow 381 Terry Wood and Mark Wigglesworth 19.1 The Role of Sample Management 381 19.2 Automation of Compound Management 382 19.3 Compound Integrity 384 19.4 Reduction of Redundancy 386 19.5 The Future of Sample Management? 387 19.6 Concluding Remarks 390 References 391 Index 393.
  • (source: Nielsen Book Data)9783527328222 20160610
Filling an obvious gap in the scientific literature, this practice-oriented reference is the first to tie together the working knowledge of large screening centers in the pharmaceutical and biotechnological field. It spans the entire field of this emerging discipline, from compound acquisition to collection optimization for specific purposes, to technology and quality control. In so doing, it applies two decades of expertise gathered by several large pharmaceutical companies to current and future challenges in high-throughput screening. With its treatment of libraries of small molecules as well as biobanks containing biomolecules, microorganisms and tissue samples, this reference is universally applicable for any molecular scientist involved in a large screening program.
(source: Nielsen Book Data)9783527328222 20160610
4 v. (cxxxviii, 1886 p.) : ill. (some col.) ; 24 cm. + 1 CD-ROM (4 3/4 in.)
Due to the impressive accumulation of out-standing results, presented by brilliant, privileged and creative thinkers, this unique book reads like the 'Who is Who' of biotechnology. Never before has such an impressive group of individuals contributed to one biotechnology book, including Nobel Prize laureates Robert Huber, Thomas R. Cech, and Manfred Eigen as well as authors from the world's most famous academic institutes and biotech companies, such as ETH Zurich, MIT, Stanford, Yale, Princeton, Harvard Medical School, Max-Planck-Institute, Fraunhofer-Institute, Moscow Academy of Sciences, London Imperial College and Baxter, Invitrogen, MorphoSys, Roche, and Schering AG. Published as a comprehensive four volume set, this title also includes a CD-ROM containing additional information and videos."Modern Biopharmaceuticals" describes: The first cloned human embryo; the first myocardial regeneration with embryonic stem cells; the first artificial kidney; the first biopharmaceutical from a transgenic animal; the first individualized medicine; the first plasma-free Factor VIII; the first approved human cell line; and, the first oral insulin, etc. '...an outstanding collection of articles from groundbreaking scientists, comprehensively describing the many novel ways cells are being deployed toward human good . ..' - James D. Watson, 'DNA Codebreaker' & Nobel Prize Laureate (Physiology or Medicine, 1962). "Modern Biopharmaceuticals" is an essential reference work for biotechnologists, clinicians, medical doctors, pharmacists, pharmaceutical chemists, bio-chemists, molecular biologists, medicinal chemists, as well as all those working in the biotechnological and pharmaceutical industries, or medicinal institutes.
(source: Nielsen Book Data)9783527311842 20160528
1 online resource (xxv, 451 pages) : illustrations
v, 443 p. : ill. ; 29 cm.
  • Introduction. Validation of Granulation Equipment. Validation of Tableting Equipment. Validation of Coating Equipment. Validation of Encapsulation Equipment. Validation of Packaging Equipment. Validation of Laboratory Equipment. Appendices. Index.
  • (source: Nielsen Book Data)9781439805947 20160612
While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.
(source: Nielsen Book Data)9781439805947 20160612
v. : ill. (some col.) ; 28 cm.
xv, 228 p. : ill. ; 24 cm.
  • What Is Validation? History & Roots of Validation Why Do We Validate & How Much Does It Cost? Who Is Responsible for Validation? How Does Validation Affect You? Validation Policy, Strategy Protocols, & the Validation Report What Activities Support the Validation Effort? What Are the Consequences of Not Validating? For Whom Are We Validating? Preparing SOPs & the Validation Master Plan How Do We Plan & Program Validation? Glossary cGMP & Standards Related to Training & Education.
  • (source: Nielsen Book Data)9781439805855 20160612
Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these principles can be bonded with quality assurance, enabling you to build the highest quality into your products. Beginning with definitions of validation, the authors guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. Packed with tools to help you follow the logic of the validation process, the book covers testing, certification, protocols, final reports, sign-offs, ways to create seamless audit trails, and other topics impacting the qualification of a system, equipment, and/or process.
(source: Nielsen Book Data)9781439805855 20160612
1 online resource (465 pages) : illustrations
1 online resource (xxviii, 203 pages) : illustrations (some color)
1 online resource (505 pages) : illustrations (some color)
ix, 594 p. : ill. (some col.) ; 24 cm.
  • Nanopharmaceutics and Clinical Therapy : Nanomaterials for Drug Delivery-- Nanomaterials for Gene Therapy-- Nanomaterials for Chemotherapy-- Nanomaterials for Pharmaceutics: Polymeric Nanomaterials-- Inorganic Nanomaterials-- Organic Nanomaterials-- Carbon Nanomaterials-- Multifunctional Nanomaterials-- Application in Pharmaceutical Development: Drug Screening-- Therapeutic Pharmaceutics-- Diagnostic Pharmaceutics and Detection.
  • (source: Nielsen Book Data)9789814368667 20160610
Nanomaterials, with their unique size-dependent physical and chemical properties, have shown promising advantages as drug and gene delivery vehicles, ultra-sensitive intracellular detectors and novel therapeutic drugs. Nanopharmaceutics is one of the disciplines that will benefit the most from this technology. Nanotechnology will have a revolutionary impact on cancer diagnosis and therapy due to the exceptional characteristics of nanopharmaceutics. This book provides an overview of some tools, methods, and materials of nanotechnology that offer potential applications in pharmaceutics, followed by a series of examples showing applications that are already in development. It may very well inspire researchers to develop a new generation of pharmaceutics with inventive non-traditional approach and employ nanoscale science for the benefit of the patient.
(source: Nielsen Book Data)9789814368667 20160610
Science Library (Li and Ma)
1 online resource (225 pages)
The pharmaceutical industry needs a shot in the arm - and not a moment too soon. The executive suite is mired in a bygone era, a time when extensive, well-funded pharmaceutical R&D produced blockbuster drugs, kept everything in-house and reaped the financial rewards. But that way of working needs to change. Executives now need to know what the technologists in their companies are doing in order to survive the next decade. Written for those new to industry, as well as for experienced professionals or specialists looking to expand their knowledge, this book is a must-read for business executives and information technologists alike. Pharma's Prescription bridges the knowledge gap between current business practices and the most valuable technologies today. This book is filled with practical, real-life examples from industry and is a straightforward guide for all pharmaceutical and information technology executives who need to improve their businesses. It focuses on practical solutions that are easily incorporated in your day-to-day work. It integrates business operations and information technology. It highlights the industry's top turn-around stories. It discusses pharmaceutical industry trends, growth opportunities, innovation drivers, regulatory complexities, and emerging market operations.
(source: Nielsen Book Data)9780124076624 20160612
xxiv, 560 p. : ill.
  • Handling of Sampled Material Control of Incoming Materials used in Production Control of Bulk and Intermediate Products Checking of Finished Products Destruction of Disposal Samples after Complete Testing and Reference Samples after Expiry Recording the Analysis and Controlling the Analytical Registers and Records Testing of Finished Products Microbiological Monitoring Program Clothing in Microbiology Laboratory Microbiological Media Handling General Cleaning and Sanitation of Microbiological Laboratory Managing Primary and Secondary Reference Standards in the Quality Control Laboratory Handling of Raw/Packaging Materials and Finished Samples in Reference Room Stability Testing Program Control of Controlled Substances (Raw Material, Bulk and Finished Products) Rounding of Significant Numbers Analytical Methods Transfer for New Products Handling Out of Specification Results Batch Auditing Procedure Validation and Certification Guidelines Product Complaints Handling Procedure Sampling of Finished Products for Laboratory Testing Sampling of Bulk Products for Laboratory Testing Product Recall Procedure Cream/Ointment In-process Audit Checks Inspection of Physical Attributes/Characteristics of Coated/Uncoated Tablets Powder In-Process Filling Audit Checks Sealing Checks of Strips and Blisters Tablets Compression Audit Checks In-Process Checks for Finishing Lines Internal QA Audit Guideline Suppository Fill Weight and Physical Attributes Check Tablets/Capsule Filling In-Process Audit Checks Physical Inspection of Attributes of Capsules Capsules In-process Audit Checks Liquid Products In-Process Audit Checks Document Security & Control and Good Documentation Guidelines Labeling for Incoming Materials, In-Process Products and Complete Processed Products Pre-Inspection Audit Guidelines for ANDA Products Operational Qualification Guideline The Retention of Records and Documents Good Manufacturing Practices in the Premises Labeling for Incoming Materials, In-Process Products and Complete Processed Products Random Sampling Physical Characteristics Check of Product and Foil during Sealing Raw Material QA Audit Checks Incidence Citation Report Technical Documents Distribution Control Key Performance Indicator Vendor Evaluation and Approval Procedure.
  • (source: Nielsen Book Data)9781439886922 20160609
To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.
(source: Nielsen Book Data)9781439886922 20160609
xiv, 321 p.
dx.doi.org SpringerLink
xviii, 548 p. : ill.
  • Dimensional Analysis and Scale-Up in Theory and Industrial Application Marko Zlokarnik Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era Fernando Muzzio Understanding Scale Up and Quality Risks on the interface between Primary and Secondary Development Frans L. Muller, Kathryn A. Gray, and Graham E. Robinson Scale-up and Process Validation Steven Ostrove Parenteral Drug Scale-Up Igor Gorsky Non-Parenteral Liquids and Semisolids Lawrence H. Block Scale-Up Considerations for Biotechnology-Derived Products Marco A. Cacciuttolo, John Chon, and Greg Zarbis-Papastoitsis Powder Handling James K. Prescott Batch Size Increase in Dry Blending and Mixing Albert W. Alexander and Fernando J. Muzzio Scale Up Of Continuous Blending Aditya U. Vanarase, Yijie Gao, Atul Dubey, Marianthi G. Ierapetritou, and Fernando J. Muzzio Scale-Up in the Field of Granulation and Drying Hans Leuenberger and Gabriele Betz Batch Size Increase in Fluid Bed Granulation Dilip M. Parikh Roller Compaction Scale-Up Ronald Miller Scale-Up of Extrusion and Spheronization Raman Iyer, Harpreet K. Sandhu and Navnit Shah Scale-Up of Compaction and the Tableting Process Matthew P. Mullarney and Jeffrey Moriarty Dimensional Analysis of the Tableting Process Michael Levin and Marko Zlokarnik Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule Formulations Larry Augsburger Scale-Up of the Film-Coating Stuart Porter Virtual scale-up of manufacturing solid dosage forms Hans Leuenberger, Michael N. Leuenberger, and Maxim Puchkov Appendix A: Relevant FDA Guidance for Industry Appendix B: Relevant EU Directives, Regulations, and Gudelines Appendix C: Relevant ICH Documents - International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use Internet link addresses.
  • (source: Nielsen Book Data)9781616310028 20160612
The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: * New material on tableting scale-up and compaction. * Regulatory appendices that cover FDA and EU Guidelines. * New chapters on risk evaluation and validation as related to scale-up. * Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.
(source: Nielsen Book Data)9781616310028 20160612
1 online resource (3 v.) : ill.
  • Volume 2: Asceptic Manufacturing Facility Design Mark Caldwell, Bob Helt, Beth Holden, Francesca McBride, and Kevin Schreier Personnel and their impact on Cleanroom Operations Jeanne Moldenhauer The Fundamentals of an Environmental Control Program William H. Miele Water Systems for Parenteral Facilities J. Manfredi Particulate Matter: Sub-Visible D. Scott Aldrich Endotoxin Testing Michael E. Dawson The Compendial Sterility Tests Scott VW Sutton Industrial Sterilization Technologies: Principles and Overview Anne F. Booth Steam Sterilization James Agalloco Gas, Vapor and Liquid Chemical Sterilization James Agalloco Dry Heat Depyrogenation and Sterilization Deborah Havlik and Kevin Trupp Radiation Sterilization Barry P. Fairand and Dusan Razem Filters and Filtration Maik W. Jornitz and Theodore H. Meltzer Processing of Small Volume Parenterals (SVPs) and Large Volume Parenterals (LVPs) Donald A. Eisenhauer, Christine Martin, Roland Schmidt, and Steven G. Schultz Freeze Drying: Principles and Practice Steven L. Nail and Larry A. Gatlin.
  • (source: Nielsen Book Data)9781420086454 20160612
  • Volume 3: CGMP Regulations of Parenteral Drugs Terry E. Munson Risk Assessment and Mitigation in Aseptic Processing James Agalloco and James Akers Validation of Drug Product Manufacturing Processes: NCEs and NBEs Karoline Bechtold-Peters Visual Inspection Maria Toler and Sandeep Nema Advances in Parenteral Injection Devices and Aids Donna L. French and James J. Collins, Jr. SiRNA Targeting Using Injectable Nano-based Delivery Systems Lan Feng and Russell J. Mumper Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls Sandeep Nema Techniques to Evaluate Damage and Pain on Injection Gayle A. Brazeau, Jessica Klapa and Pramod Gupta Parenteral Product Specifications and Stability Michael Bergren Extractables and Leachables Edward Smith and Dianne M. Paskiet Process Analytical Technology and Rapid Microbial Methods Geert Verdonk and Tony Cundell Quality Assurance Michael Gorman Application of Quality by Design in CMC Development Roger Nosal, Tom Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh Future of Parenteral Manufacturing James Agalloco, James Akers, and Russell Madsen.
  • (source: Nielsen Book Data)9781420086478 20160612
  • Volume I Parenteral Dosage Forms: Introduction and Historical Perspectives John D. Ludwig Parenteral Drug Administration: Routes of Administration and Devices Himanshu Bhattacharjee and Laura A. Thoma Biopharmaceutics and Immunogenicity of Biotherapeutics Balaji Agoram, Kazuko Sagawa, Ravi M Shanker, and Satish Singh Preformulation Research of Parenteral Medication Murti Vemuri Formulation Development of Small and Large Volume Injections Madhav Kamat and Patrick P. DeLuca Solubility and Solubilization Michael Hageman Formulation of Depot Delivery Systems James J. Cunningham, Marc J. Kirchmeier, and Sachin Mittal Biophysical and Biochemical Characterization of Peptide and Protein Drug Product Tapan K. Das and James A. Carroll Formulation of Protein- and Peptide-based Parenteral Products Gaozhong Zhu and Y. John Wang Development of Ophthalmic Formulations Paramita Bandyopadhyay, Martin J. Coffey, and Mohannad Shawer Glass containers for Parenteral Products Robert Swift Plastic Packaging for Parenteral Drug Delivery Vinod D. Vilivalam and Fran DeGrazio Elastomeric Closures for Parenterals Renaud Janssen Parenteral Product Container-Closure Integrity Testing Dana Morton Guazzo.
  • (source: Nielsen Book Data)9781420086430 20160612
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume one presents: A historical perspective of injectable drug therapy, common routes of administration, and biopharmaceutics of NCEs and NBEs. An in-depth discussion on the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. A presentation of parenteral primary packaging options - glass and plastic containers, as well as elastomeric closures. A definitive chapter on container-closure integrity. New chapters on solubility and solubilization, formulation of depot delivery systems and biophysical/biochemical characterization of proteins.
(source: Nielsen Book Data)9781420086430 20160612
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume three presents: * An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. * Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing. * Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems. * New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.
(source: Nielsen Book Data)9781420086478 20160612
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume two presents: * Chapters on aseptic facility design, environmental monitoring, and cleanroom operations. * A comprehensive chapter on pharmaceutical water systems. * A discussion of quality attributes of sterile dosage forms, including particulate matter, endotoxin, and sterility testing. * A detailed chapter on processing of parenteral drug products (SVPs and LVPs). * Presentations on widely used sterilization technologies - steam, gas / chemical, radiation, filtration and dry heat. * An in-depth chapter on lyophilization.
(source: Nielsen Book Data)9781420086454 20160612
xiv, 222 p. : ill.
  • Introduction Fundamentals Fluid Flow Heat Transfer Mass Transfer Powders Processes Air Conditioning and Humidification Drying Solid-Liquid Extraction Crystallization Evaporation and Distillation Filtration Size, Reduction and Classification Mixing Solid Dosage Forms Sterilization Bioprocessing Quality Principles Quality by Design Statistical Experimental Design Process Analytical Technology Conclusion.
  • (source: Nielsen Book Data)9781420084764 20160612
With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmaceutical scientists and technologists up-to-date IDEAL INTRODUCTORY TEXT - Covers basic engineering principles, drug production, and development processes, so scientists can easily convert bulk pharmaceutical products into patient-ready dosage forms NEW INFORMATION - on quality principles that include quality by design; mathematical and statistical approaches to experimental design; computer aided design; and PAT (process analytical technology) keeps professionals at the forefront of their field COMPREHENSIVE COVERAGE - Step-by-step methods of drug production, knowledge of major unit operations, and key concepts of pharmaceutical engineering will help to improve communication among the varied professionals working in the pharmaceutical industry.
(source: Nielsen Book Data)9781420084764 20160612
xviii, 190 p. : ill. (some col.)
  • Definition and classification of biologics.- Development and pre-clinical pharmacology of biologics: Infliximab -- from the idea to the product. Adalimumab. Etanercept. Efalizumab (Raptiva) -- antibody characteristics, mode of action and preclinical development. Monoclonal antibody targeted radiation cancer therapy. The production of biopharmaceuticals.- Disease-specific applications and clinical trials: Treating autoimmune bullous skin disorders with biologics. Biologics in psoriasis. Biologic agents in psoriatic arthritis. Biologic therapies for rheumatoid arthritis targeting TNFa and IL-1. Biologics in Crohn's Disease and ulcerative colitis. Multiple sclerosis: new immunobiologics. Biologics in cutaneous lymphoma. Biologics in targeted cancer therapy.- Safety and Perspectives: Safety aspects of biologics -- lessons learnt from monoclonal antibodies. New biological therapeutics in the genome age. Evidence-based medicine's perspective on biologics.
  • (source: Nielsen Book Data)9783540290179 20160528
This is the first book comprising all relevant aspects for the clinical application of biologicals. All biologicals currently approved for clinical use are described in a standardized way concentrating on practically relevant aspects such as contra-indications or monitoring needs. The "differential therapy" with biologicals namely in the fields of dermatology, rheumatology, gastroenterology, and neurology is described in detail and summarized in treatment algorithms. Shorter sections on the biotechnology behind the biologicals as well as safety, regulatory, and pharmaco-economic aspects complement the more clinically-oriented central chapters.
(source: Nielsen Book Data)9783540290179 20160528


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