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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)
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)
online resource (413 pages) : ill ; 26 cm
  • High throughput sample preparation techniques and their application to bioanalytical protocols and purification of combinatorial libraries / Krishna Kallury
  • High-throughput quantitative bioanalysis / Katty X. Wan
  • Optimizing LCMS equipment to increase throughput in pharmaceutical analysis / Michael G. Frank and Douglas E. Mcintyre
  • Throughput improvement of bioanalytical LC-MS/MS by sharing of detector between HPLC systems / Min Shuan Chang and Tawakol El-Shourbagy
  • High throughput strategies for metabolite identification in drug discovery / Patrick J. Rudewicz, Qin Yue, and Young Shin
  • Utilizing micro parallel liquid chromatography for high-throughput analyses in the pharmaceutical industry / Sergio A. Guazzotti
  • Strategies and techniques for higher throughput ADME/PK assays / Walter Korfmacher
  • High-throughput analysis in drug metabolism during early drug discovery / Yau Yi Lau
  • High-throughput analysis in the support of process chemistry and formulation research & development in the pharmaceutical industry / Zhong Li
  • On-line SPE LC/MS/MS for high throughput bioanalytical analysis / Dong Wei and Liyu Yang
  • Applications of high-throughput analysis in therapeutic drug monitoring / Quanyun A. Xu and Timothy L. Madden
  • High-throughput quantitative pharmaceutical analysis in drug metabolism and pharmacokinetics (DMPK) using liquid crhomatrography-mass spectrometry / Xiaohui Xu
  • Designing high throughput HPLC assays for small and biological molecules / Roger K. Gilpin and Wanlong Zhou
  • The advances in capillary and nano-HPLC technology for drug discovery and development / Frank J. Yang and Richard Yu
  • High-throughput analysis of complex protein mixtures by mass spectrometry / Kojo S.J. Elenitoba-Johnson.
Medical Library (Lane)
computer files (xiii, 314 pages) : illustrations ; 25 cm
Medical Library (Lane)
online resource (xxii, 356 pages) : illustrations ; 25 cm
  • Inflammatory mechanisms in Alzheimer's disease and other neurodegenerative disorders / Joseph Rogers ... [et al.]
  • Treatment development strategies for Alzheimer's disease / Ernst Wulfert
  • Lipoprotein-associated phospholipase A as a new prognostic factor for coronary artery disease / Alexandros D. Tselepis
  • New molecular targets for the prevention and treatment of gastrointestinal ulcers and inflammation / Sandor Szabo ... [et al.]
  • Stress activates corticotropin releasing : factor signaling pathways : implication in functional bowel disorders / Yvette Tache
  • Design, synthesis, and pharmacological evaluation of high-affinity and selectivity sigma-1 and sigma-2 receptor ligands / Jacques H. Poupaert
  • Synthesis of biologically active taxoids / K.C. Nicolaou and R.K. Guy
  • From the molecular pharmacology to the medicinal chemistry of cannabinoids / Didier M. Lambert
  • An appraisal of fomocaines : current situation and outlook / Herbert Oelschlager and Andreas Seeling
  • Ligands for the GABA recognition site at the GABAA receptor : structure-activity studies / Bente Frlund ... [et al.]
  • Strategies for development of new lead structures for inhibition of acetylcholinesterase / Petra Kapkova ... [et al.]
  • Discovery of potent and selective inhibitors of human aldosterone synthase (CYP11B2) : a new target for the treatment of congestive heart failure and myocardial fibrosis--a review / R.W. Hartmann ... [et al.]
  • Thiocarboxanilides : a new class of nonnucleoside reverse transcriptase inhibitors (NNRTIs) with great potential for the treatment of human immunodeficiency virus type 1 (HIV-1) infections / E. De Clercq, A. Karlsson, and J. Balzarini
  • Histamine H-receptor agonists and antagonists : chemical, pharmacological, and clinical aspects / Holger Stark and Walter Schunack
  • Anti-inflammatory actions of flavonoids and structural requirements for new design / Theoharis C. Theoharides
  • Molecular mechanisms of HO-induced DNA damage : the action of desferrioxamine / M. Tenopoulou, P.-T Doulias, and D. Galaris
  • LNA (locked nucleic acid) and functionalized LNA : towards efficient gene targeting / Jesper Wengel
  • The effect of diet on drug metabolism / K.J. Netter
  • Cytochromes P450 in the metabolism and bioactivation of chemicals / Costas Ioannides
  • In vitro methods to measure drug metabolism and drug interactions in drug discovery and development / O. Pelkonen ... [et al.]
  • How to probe the sites of action of drug molecules / A. Makriyannis and F. Bitter
  • Physicochemical profiling in early drug discovery : new challenges at the age of high-throughput screen and combinatorial chemistry / Bernard Faller
  • Drug membrane interaction and its importance for drug efficacy / J.K. Seydel ... [et al.]
  • The fight against AIDS : new avenues for inhibiting reverse transcriptase (RT), and old target / Maurizio Botta ... [et al.].
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)
computer files (ix, 243 pages : illustrations ; 26 cm)
  • Application of parallel synthesis to the optimization of inhibitors of the ZipA-FtsZ protein-protein interaction / Lee D. Jennings
  • Case studies of parallel synthesis in hit identification, hit exploration, hit-to-lead, and lead optimization programs / Alexander Ernst and Daniel Obrecht
  • A successful application of parallel synthesis to computer-assisted structural optimization of new leads targeting human immunodeficiency virus-1 reverse transcriptase : the case of acylthiocarbamates and thiocarbamates / Angelo Ranise, Andrea Spallarossa, and Sara Cesarini
  • How high-throughput medicinal chemistry can expedite lead discovery, lead optimization, and beyond / Rongshi Li
  • Rapid lead identification of inhibitors of adenine nucleotide translocase: a case study of applying combinatorial chemistry techniques in drug discovery / Yazhong Pei, Walter H. Moos, and Soumitra Ghosh
  • Parallel synthesis of anticancer, antiinflammatory, and antiviral agents derived from L- and D-amino acids / Robert C. Reid and David P. Fairlie
  • Application of solid-phase parallel synthesis in lead optimization studies / Bijoy Kundu
  • High-throughput solid-phase synthesis of nucleoside-based libraries in the search for new antibiotics / Dianqing Sun and Richard E. Lee.
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)
computer files (633 pages : illustrations ; 27 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)
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 (x, 352 pages), [8] pages of plates : illustrations (some color) ; 24 cm
  • Nanoparticulate drug-delivery systems: an overview / Deepak Thassu, Yashwant Pathak and Michel Deleers
  • Nanosuspensions for parenteral delivery / Barrett E. Rabinow
  • Nanoparticles prepared using natural and synthetic polymers / Sudhir S. Chakravarthi, Dennis H. Robinson and Sinjan De
  • Nanofiber-based drug delivery / Matthew D. Burke and Dmitry Luzhansky
  • Drug nanocrystals - the universal formulation approach for poorly soluble drugs / Jan Möschwitzer and Rainer H. Müller
  • Lipid-based nanoparticulate drug delivery systems / Jun Wu, Xiaobin Zhao and Robert J. Lee
  • Nanoengineering of drug delivery systems / Ashwath Jayagopal and V. Prasad Shastri
  • Aerosol flow reactor method for the synthesis of multicomponent drug nano- and microparticles / Janne Raula ... [et al.]
  • Supercooled smectic nanoparticles / Heike Bunjes and Judith Kuntsche
  • Biological and engineering considerations for developing tumor-targeting metallic nanoparticle drug-delivery systems / Giulio F. Paciotti and Lawrence Tamarkin
  • Biological requirements for nanotherapeutic applications / Joseph F. Chiang
  • Role of nanobiotechnology in the development of nanomedicine / K.K. Jain
  • Pharmaceutical applications of nanoparticulate drug-delivery systems / Yashwant Pathak, Deepak Thassu and Michel Deleers
  • Lipid nanoparticles (solid lipid nanoparticles and nanostructured lipid carriers) for cosmetic, dermal, and transdermal applications / Eliana B. Souto and Rainer H. Müller
  • Nano-carriers of drugs and genes for the treatment of restenosis / Einat Cohen-Sela ... [et al.]
  • Ocular applications of nanoparticulate drug-delivery systems / Annick Ludwig
  • Nanoparticulate systems for central nervous system drug delivery / Jean-Christophe Olivier and Manuela Pereira de Oliveira
  • Nanoparticles for gene delivery: formulation characteristics / Jaspreet K. Vasir and Vinod Labhasetwar
  • Gastrointestinal applications of nanoparticulate drug-delivery systems / Maria Rosa Gasco
  • Nanoparticles as adjuvant-vectors for vaccination / Socorro Espuelas ... [et al.]
  • Transdermal applications of nanoparticulates / Jongwon Shim.
Medical Library (Lane)
computer files (ix, 363 pages : illustrations ; 24 cm)
Medical Library (Lane)
computer files (204 pages : illustrations ; 24 cm)
  • The enormous initial mistake
  • The origins of six sigma
  • Evolution
  • Revolution
  • Paradox
  • Action and reaction
  • Close enough or on target?
  • Make more-- faster!
  • Case studies
  • The camera always lies
  • Keeping it simple
  • Why use control charts?
  • Average and range control charts
  • Origins and theory
  • Charts for individuals
  • Practical considerations
  • Improving laboratories
  • Beyond compliance.
Medical Library (Lane)
computer files (viii, 459 pages : illustrations)
Medical Library (Lane)
714 pages : illustrations ; 25 cm
Medical Library (Lane)