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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)
online resource (311 pages)
  • 1. Introduction to chamomile
  • 2. Chamomile : botany
  • 3. Chamomile : medicinal properties
  • 4. Chamomile oil and extract : localization, chemical composition, extraction, and identification
  • 5. Genetics and breeding of chamomile
  • 6. Cultivation of chamomile
  • 7. Chamomile : patents and products.
Medical Library (Lane)
xii, 384 pages : illustrations (some color)
  • Evolution of Antimicrobial Peptides: A View from the Cystine Chapel
  • Innate Immunity in Plants: The Role of Antimicrobial Peptides
  • Antimicrobial Peptides Produced by Microorganisms
  • LL-37: An Immunomodulatory Antimicrobial Host Defence Peptide
  • Wound Repair and Antimicrobial Peptides
  • WAPing Out Pathogens and Disease in the Mucosa: Roles for SLPI and Trappin-2
  • Histatins: Multifunctional Salivary Antimicrobial Peptides
  • Structure-Function Relationships of Antimicrobial Chemokines
  • Mechanisms and Significance of Bacterial Resistance to Human Cationic Antimicrobial Peptides
  • Antimicrobial Peptides and Inflammatory Bowel Disease
  • Cystic Fibrosis and Defective Airway Innate Immunity
  • Antimicrobial Peptides in Chronic Obstructive Pulmonary Disease
  • Host Defense Peptides: Immune Modulation and Antimicrobial Activity In Vivo
  • Helping the Host: Induction of Antimicrobial Peptides as a Novel Therapeutic Strategy Against Infections.
Medical Library (Lane)
1 volume (various pagings) : illustrations ; 26 cm
Medical Library (Lane)
computer files (xiii, 314 pages) : illustrations ; 25 cm
Medical Library (Lane)
online resource (x, 251 pages) : illustrations ; 24 cm
  • Drug delivery systems--an overview / Kewal K. Jain
  • The role of the adeno-associated virus capsid in gene transfer / Kim M. Van Vliet ... [et al.]
  • Delivering small interfering RNA for novel therapeutics / Patrick Y. Lu and Martin C. Woodle
  • Catheters for chronic administration of drugs into brain tissue / Michael Guarnieri, Benjamin S. Carson, Sr., and George I. Jallo
  • Transdermal drug delivery systems : skin perturbation devices / Marc B. Brown ... [et al.]
  • Controlling the release of proteins/peptides via the pulmonary route / Sunday A. Shoyele
  • Engineering protein particles for pulmonary drug delivery / Sunday A. Shoyele
  • 2B-Trans technology : targeted drug delivery across the blood-brain barrier / Pieter J. Gaillard and Albertus G. de Boer
  • Drug delivery in cancer using liposomes / Crispin R. Dass
  • pH-responsive nanoparticles for cancer drug deliery / Youqing Shen ... [et al.]
  • Extended-release oral drug delivery technologies : monolithic matrix systems / Sandip B. Tiwari and Ali R. Rajabi-Siahboomi.
Medical Library (Lane)
xiv, 1377 pages, 8 pages of plates ; illustrations (some color) 29 cm
Medical Library (Lane)
vii, 248 pages : illustrations ; 24 cm
  • Strategic project management at the project level / Tony Kennedy
  • Strategic project management at the portfolio level / Kevin Bilyard and Des Markland
  • Project planning : from basic concepts to systems application / Carl A. Kutzbach, Carole Strong, and Sylvia Walker
  • Project management of chemical, analytical, and formulation development / Dieter Krimmer
  • Project management in exclusive synthesis / Lukas M.J. von Hippel
  • Clinical trials--can they be project managed? / Les Rose
  • Regulatory project management / Nicholas Wells
  • Teams / Ralph White
  • Project management and outsourcing drug development / Jon Court and Mark Fowler
  • The project management function / Tony Kennedy.
Medical Library (Lane)
xxxvi, 1501 pages, [7] pages of plates : illustrations (some color) ; 26 cm
Medical Library (Lane)
viii, 398 pages : illustrations ; 26 cm
  • Preface / Joseph D. Nally
  • Contributors
  • 1. Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holding of Drugs / Joseph D. Nally
  • 2. Finished Pharmaceuticals: General Provisions, Subpart A / Joseph D. Nally
  • 3. Organization and Personnel, Subpart B / Joanne W. Cochran and Joseph D. Nally
  • 4. Buildings and Facilities, Subpart C / Robert Del Ciello
  • 5. Equipment, Subpart D / Robert Del Ciello, Joseph T. Busfield, and Steven Ostrove
  • 6. Control of Components and Drug Product Containers and Closures , Subpart E / Arlyn R. Sibille
  • 7. Production and Process Controls, Subpart F / Joseph D. Nally and Michael D. Karaim
  • 8. Packaging and Labeling Control, Subpart G / Arlyn R. Sibille
  • 9. Holding Distribution, Subpart H / Joseph D. Nally
  • 10. Laboratory Controls, Subpart I / Wayne J. DeWitte and Lex M. Hoinowski
  • 11. Records and Reports, Subpart J / Arlyn R. Sibille, Steven Ostrove, Joseph D. Nally, and Laura L. Nally
  • 12. Returned and Salvaged Drug Products, Subpart K / Joseph D. Nally
  • 13. Repacking and Relabeling / Joseph D. Nally
  • 14. Quality Systems and Risk Management Approaches / Joseph D. Nally and Laura L. Nally
  • 15. Clinical Trial Supplies and Current Good Manufacturing / Graham Bunn
  • 16. Contracting and Outsourcing / Graham Bunn
  • 17. Active Pharmaceutical Ingredients / P. Denis Celentano
  • 18. Bulk Pharmaceutical Excipient GMPs / Irwin Silverstein
  • 19. Recalls, Warning Letters, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States / Joseph D. Nally
  • 20. Control Substances Safeguards (21 CFR 1300, et seq.) / Joseph D. Nally
  • 21. The Inspection Procedures for Compliance in the United States: The Regulatee is Inspected; The Rational for Inspection (21 USC 373, 374) / Joseph D. Nally
  • 22. FDA Pre-Approval Inspections/Investigations: The Road from Scale-Up and Post-Approval Changes in the Food and Drug Modernization Act / Joseph D. Nally
  • 23. World-Wide Good Manufacturings Practices / Joseph D. Nally
  • 24. Quality Approaches: ISO 9000, Malcolm Baldrige, and Six Sigma / Joseph D. Nally
  • Appendix A: Center for Drug Evaluation and Research: List of Guidance Documents
  • Appendix B: ICH Guidelines
  • Appendix C: Food and Drug Administration (FDA) Office Regulatory Affairs (ORA) Compliance Policy Guides
  • Index.
Medical Library (Lane)
computer files (x, 812 pages, [32] pages of plates : color illustrations ; 24 cm)
Medical Library (Lane)

12. Liposome technology [2007]

3 volumes : illustrations ; 24 cm
  • v. 1. Liposome preparation and related techniques
  • v. 2. Entrapment of drugs and other materials into liposomes
  • v. 3. Interactions of liposomes with the biological milieu.
Medical Library (Lane)
computer files (viii, 459 pages : illustrations)
Medical Library (Lane)
714 pages : illustrations ; 25 cm
Medical Library (Lane)
computer files (ix, 237 pages : illustrations ; 24 cm)
Medical Library (Lane)
computer files (xii, 228 pages) : illustrations ; 27 cm
  • Anti-Inflammatory Plants
  • Plants Affecting the Central Nervous System
  • Plants for Chemotherapy of Neoplastic Diseases.
Medical Library (Lane)
[xxii], 918 pages : illustrations ; 29 cm
Medical Library (Lane)
computer files (xviii, 430 pages) : illustrations, ; 25 cm
  • Reverse pharmacognosy : a new concept for accelerating natural drug discovery / Quoc-Tuan Do and Philippe Bernard
  • Effects of plant extracts on gene expression profiling : from macroarrays to microarray technology / Carlo Mischiati, Alessia Sereni, Mahmud Tareq Hassan Khan, Ilaria Lampronti and Roberto Gambari
  • Effects of medicinal plant extracts on molecular interactions between DNA and transcription factors / Ilaria Lampronti, Mahmud Tareq Hassan Khan, Nicoletta Bianchi, Giordana Feriotto, Carlo Mischiati, Monica Borgatti and Roberto Gambari
  • Plants with antitumor properties : from biologically active molecules to drugs / Ilaria Lampronti, Mahmud Tareq Hassan Khan, Nicoletta Bianchi, Elisabetta Lambertini, Roberta Piva, Monica Borgatti and Roberto Gambari
  • Herbal extracts and compounds active against herpes simplex virus / Kenneth D. Thompson
  • Pharmacological modulation of cough reflex / Gabriela Nosalova, Juraj Mokry and Sona Franova
  • Phytotherapy of cough / Sona Franova, Gabriela Nosalova and Juraj Mokry
  • The medicinal potential of black seed (Nigella sativa) and its components / Hala Gali-Muhtasib, Nahed El-Najjar and Regine Schneider-Stock
  • Cyclin-dependent kinase inhibitors from natural sources : recent advances and future prospects for cancer treatment / Hala Gali-Muhtasib
  • Anticancer and medicinal properties of essential oil and extracts of East Mediterranean sage (salvia triloba) / Hala Gali-Muhtasib
  • Marine organisms from Brazil as source of potential anticancer agents / Letícia Veras Costa-Lotufo, Cláudia Pessoa, Maria Elisabete A. Moraes, Adaíla Marta Paixão Almeida, Manoel Odorico de Moraes and Tito Monteiro da Cruz Lotufo
  • Anticancer potential of Northeast Brazilian plants / Cláudia Pessoa, Letícia Veras Costa-Lotufo, Albert Leyva, Maria Elisabete Amaral de Moraes and Manoel Odorico de Moraes
  • Safety and efficacy of phytomedicines / Manoel Odorico de Moraes, Fernando Antônio Frota Bezerra, Letícia Veras Costa-Lotufo, Cláudia Pessoa and Maria Elisabete Amaral de Moraes
  • Pharmacological and biochemical profiling of lead compounds from traditional remedies : the case of Croton cajucara / Maria Aparecida M. Maciel, Tereza Neuma C. Dantas, Janaína Keila P. Câmara, Angelo C. Pinto, Valdir F. Veiga Jr., Carlos R. Kaiser, Nuno A. Pereira, Cristina M.T.S. Carneiro, Frederico A. Vanderlinde, Antônio J. Lapa, Aniele R. Agner, Ilce M.S. Cólus, Juliana Echevarria-Lima, Noema F. Grynberg, Andressa Esteves-Souza, Kenia Pissinate and Aurea Echevarria
  • Antihypertensive peptides from natural resources / Toshiro Matsui and Kiyoshi Matsumoto
  • Xanthones as therapeutic agents : chemistry and pharmacology / Noungoue Tchamo Diderot, Ngouela Silvere and Tsamo Etienne
  • Inhibition of immunodeficiency type-1 virus (HIV-1) life cycle by medicinal plant extracts and plant-derived compounds / Roberto Gambari and Ilaria Lampronti
  • Anticancer properties of saffron, Crocus sativus Linn. / José-Antonio Fernández
  • Lead compounds and drug candidates from some Turkish plants for human health / İlkay Orhan and Bilge Şener
  • Molecular design of multifunctional anti-Salmonella agents based on natural products / Isao Kubo, Ken-ichi Fujita, Ken-ichi Nihei and Aya Kubo
  • Plant growth inhibitory activities by secondary metabolites isolated from Latin American flora / Carlos L Céspedes, Juan C Marín, Mariana Domínguez, J Guillermo Avila and Blanca Serrato
  • Metabolomics : systematic studies of the metabolic profiling / Mahmud Tareq Hassan Khan and Arjumand Ather.
Medical Library (Lane)
1 volume (various pagings) : illustrations ; 26 cm
Medical Library (Lane)
computer files (xv, 437 pages, [20] pages : illustrations (some color) ; 26 cm)
  • A survey of novel molecular targets for anticancer drug discovery
  • Microarrays: small spots produce major advances in pharmacogenomics
  • Strategies to target chemotherapeutics to tumors
  • QSAR and pharmacophore mapping strategies in novel anticancer drug discovery
  • Applications of nuclear magnetic resonance and mass spectrometry to anticancer drug discovery
  • Antisense strategies for the development of novel cancer therapeutics
  • Antibodies and vaccines as novel cancer therapeutics
  • Inhibitors as targets for cancer therapy
  • Preclinical testing and validation of novel anticancer agents
  • Surrogate end points and biomarkers for early trials of novel anticancer agents
  • Regulatory considerations in clinical trials of novel anticancer drugs
  • Improving the efficacy and safety of anticancer agents: the role of pharmacogenetics
  • Imaging of pharmacodynamic end points in clinical trials
  • Devising proof-of-concept strategies in oncology clinical trials
  • Clinical trial designs for cytostatic agents and agents directed at novel molecular targets
  • Cancer gene therapy clinical trials: from the bench to the clinic
  • Molecular targets for radiosensitization
  • Patient accrual to clinical trials.
Medical Library (Lane)