Handbook Of Pharmaceutical Biotechnology

Handbook of Pharmaceutical Biotechnology PDF
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 9780470117101
Size: 11.39 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 1680
View: 5832

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A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.

Handbook Of Pharmaceutical Biotechnology

Handbook of Pharmaceutical Biotechnology PDF
Author: Jay P Rho
Publisher: CRC Press
ISBN: 9780789016355
Size: 45.46 MB
Format: PDF, ePub, Docs
Category : Medical
Languages : en
Pages : 191
View: 3772

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Stay up to date with changes in the biopharmaceutical products market! With the growth rate of biopharmaceutical products ascending rapidly since the 1980s, the number of biotechnology companies has risen to more than 1200 new businesses in the Unites States alone. This dramatic increase creates a new set of challenges in education, putting demands on teachers and students to keep pace with innovations in terminology and techniques. The Handbook of Pharmaceutical Biotechnology is essential in meeting those challenges. A practical compendium of biotechnology-produced drugs, the Handbook of Pharmaceutical Biotechnology covers general principles of biotechnology and pharmaceuticals, putting usable information in the hands of those who need it most. The book presents descriptions that break down each pharmaceutical product by pharmacology, pharmacokinetics, clinical applications, toxicities, and dosage guidelines. It also reviews prescription products, discussing clinical uses and trials, adverse reactions, and more. Tables, figures, and extensive references add to each comprehensive summary. The Handbook of Pharmaceutical Biotechnology also includes up-to-date information on: monoclonal antibodies (Abciximab, Muromonab-CD3) enzymes and regulators of enzyme activity (Alteplase, clotting factors, Dornase alpha) anticytokines olgonucleotide and gene therapy hematopoietic growth factors (interleukins, interferons, colony stimulating factors, erythropoietin) As the worldwide production and sales of biotechnology-derived pharmaceuticals and diagnostics continues to grow, teachers, students, and clinical pharmacists need to maintain a clear and current understanding of the field. The Handbook of Pharmaceutical Biotechnology presents a thoughtful and thorough guide to keeping pace in this evolving industry.

Handbook Of Biogeneric Therapeutic Proteins

Handbook of Biogeneric Therapeutic Proteins PDF
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1000611329
Size: 75.42 MB
Format: PDF, Kindle
Category : Medical
Languages : en
Pages : 584
View: 5149

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More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato

Manufacturing Of Pharmaceutical Proteins

Manufacturing of Pharmaceutical Proteins PDF
Author: Stefan Behme
Publisher: John Wiley & Sons
ISBN: 3527627685
Size: 40.38 MB
Format: PDF, ePub, Mobi
Category : Science
Languages : en
Pages : 404
View: 3935

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This comprehensive introduction covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues as well as costing procedures. Written by a leading expert at one of the largest pharmaceutical companies worldwide, this practical text is aimed at a wide audience, ranging from libraries, via biotech companies to students and technicians planning to enter biopharmaceutical manufacturing. In addition, it is well suited for academic teaching as well as internal training within larger biotech or pharmaceutical companies.

Handbook Of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations PDF
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 9781420048452
Size: 20.28 MB
Format: PDF, ePub, Docs
Category : Medical
Languages : en
Pages : 256
View: 7686

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The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing liquid drugs and the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs.

Springer Handbook Of Marine Biotechnology

Springer Handbook of Marine Biotechnology PDF
Author: Se-Kwon Kim
Publisher: Springer
ISBN: 3642539718
Size: 57.89 MB
Format: PDF, Mobi
Category : Science
Languages : en
Pages : 1512
View: 3652

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This Springer Handbook provides, for the first time, a complete and consistent overview over the methods, applications, and products in the field of marine biotechnology. A large portion of the surface of the earth (ca. 70%) is covered by the oceans. More than 80% of the living organisms on the earth are found in aquatic ecosystems. The aquatic systems thus constitute a rich reservoir for various chemical materials and (bio-)chemical processes. Edited by a renowned expert with a longstanding experience, and including over 60 contributions from leading international scientists, the Springer Handbook of Marine Biotechnology is a major authoritative desk reference for everyone interested or working in the field of marine biotechnology and bioprocessing - from undergraduate and graduate students, over scientists and teachers, to professionals. Marine biotechnology is concerned with the study of biochemical materials and processes from marine sources, that play a vital role in the isolation of novel drugs, and to bring them to industrial and pharmaceutical development. Today, a multitude of bioprocess techniques is employed to isolate and produce marine natural compounds, novel biomaterials, or proteins and enzymes from marine organisms, and to bring them to applications as pharmaceuticals, cosmeceuticals or nutraceuticals, or for the production of bioenergy from marine sources. All these topics are addressed by the Springer Handbook of Marine Biotechnology. The book is divided into ten parts. Each part is consistently organized, so that the handbook provides a sound introduction to marine biotechnology - from historical backgrounds and the fundamentals, over the description of the methods and technology, to their applications - but it can also be used as a reference work. Key topics include: - Marine flora and fauna - Tools and methods in marine biotechnology - Marine genomics - Marine microbiology - Bioenergy and biofuels - Marine bioproducts in industrial applications - Marine bioproducts in medical and pharmaceutical applications - and many more...

Handbook Of Pharmaceutical Controlled Release Technology

Handbook of Pharmaceutical Controlled Release Technology PDF
Author: Donald L. Wise
Publisher: CRC Press
ISBN: 9780824703691
Size: 28.56 MB
Format: PDF, ePub, Docs
Category : Medical
Languages : en
Pages : 902
View: 3374

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The Handbook of Pharmaceutical Controlled Release Technology reviews the design, fabrication, methodology, administration, and classifications of various drug delivery systems, including matrices, and membrane controlled reservoir, bioerodible, and pendant chain systems. Contains cutting-edge research on the controlled delivery of biomolecules! Discussing the advantages and limitations of controlled release systems, the Handbook of Pharmaceutical Controlled Release Technology covers oral, transdermal, parenteral, and implantable delivery of drugs discusses modification methods to achieve desired release kinetics highlights constraints of system design for practical clinical application analyzes diffusion equations and mathematical modeling considers environmental acceptance and tissue compatibility of biopolymeric systems for biologically active agents evaluates polymers as drug delivery carriers describes peptide, protein, micro-, and nanoparticulate release systems examines the cost, comfort, disease control, side effects, and patient compliance of numerous delivery systems and devices and more!

Handbook Of Bioentrepreneurship

Handbook of Bioentrepreneurship PDF
Author: Holger Patzelt
Publisher: Springer Science & Business Media
ISBN: 9780387483450
Size: 59.41 MB
Format: PDF, ePub, Mobi
Category : Business & Economics
Languages : en
Pages : 296
View: 5693

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Providing an important and timely overview of research on the exciting area of entrepreneurship in biotechnology, The Handbook of Bioentrepreneurship examines one of the most promising industries of the 21st century. While genetically engineered food and biopharmaceuticals have made biotechnology part of our everyday life, starting a bioventure is among the most complex and risky entrepreneurial tasks given long development cycles, high technological and market uncertainty, and high capital intensity. Providing unparalleled in-depth and detailed analysis, this Handbook sheds light on business models and strategies, financing, cooperation networks between firms and universities, among other issues. With new developments in biotechnology increasingly in the news, this is an important source for readers interested in public policy, entrepreneurship, and business in the 21st century.

Handbook Of Pharmaceutical Public Policy

Handbook of Pharmaceutical Public Policy PDF
Author: Thomas Fulda
Publisher: CRC Press
ISBN: 9781439804261
Size: 70.15 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 681
View: 5711

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Get an invaluable view of the impact of economics and politics on pharmaceuticals in the United States Pharmacy and pharmaceutical drug use are highly regulated and the various regulatory forces interact with diverse goals. Pharmaceutical Public Policy is a comprehensive review of the legislation, trends, business developments, and policy interpretations that have shaped drug use during the last 50 years. This unique single source explains drug regulatory activity, the major insurance and payment systems, and the impact of economics and politics on drug use in the United States. Leading experts provide a thorough and objective look at public policy issues, making this text perfect for upper level undergraduate and graduate level pharmacy, medical, and public health educators and students. Pharmacists and pharmacy students must learn more than just the physical sciences and clinical aspects of the pharmaceutical industry. The rationale for policies, rules, and regulations is integral to understanding how to best serve patients and make the entire pharmaceutical sector more equitable and cost-effective. Pharmaceutical Public Policy examines the most pressing issues facing the industry, including control of the rising costs for drugs and ensuring correct drug usage by patients. This insightful text offers an in depth perspective of the policies and the debates that surround them. Chapters are well-referenced and many include helpful figures and tables to illustrate facts and ideas. Topics in Pharmaceutical Public Policy include: pharmacy law and regulation Medicare and prescription drug coverage FDA drug approval process Medicaid and prescription drugs public health pharmacy Department of Veterans Affairs pharmacy programs Department of Defense pharmacy programs innovative state drug program practices state and federal regulation of pharmacy the future of the pharmaceutical industry managed care pharmacy PBM’s (pharmacy benefit managers) risk minimization importation and reimportation biotechnology and pharmacogenetics policy and issues product promotion competition between drugs drug insurance design patient compliance abuse of prescription drugs health care systems and insurance in Europe much more Pharmaceutical Public Policy is a one-of-a-kind resource that explains just who the players are and the complexity of the issues that are examined in most pharmaceutical policy debates, and is perfect for pharmacy students, educators, other health professionals, trade association leaders, and policymakers.