Generics and Bioequivalence, 

Автор: Isadore Kanfer
Название: Bioequivalence Requirements in Various Global Jurisdictions
ISBN: 3319680773 ISBN-13(EAN): 9783319680774
Издательство: Springer
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Цена: 25155.00 р.
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Описание:

Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the

Автор: Niazi Sarfaraz K
Название: Handbook Of Bioequivalence Testing
ISBN: 0849303958 ISBN-13(EAN): 9780849303951
Издательство: Taylor&Francis
Цена: 22968.00 р.
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Описание: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete and timely description of every aspect of bioequivalence testing, including worldwide regulatory requirements for filing for approval of generic drugs, applying for a waiver, securing regulatory approval of reports, and obtaining regulatory certification of facilities conducting bioequivalence studies.

Автор: Vinod P. Shah; Howard I. Maibach; John Jenner
Название: Topical Drug Bioavailability, Bioequivalence, and Penetration
ISBN: 1493938568 ISBN-13(EAN): 9781493938568
Издательство: Springer
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Цена: 18284.00 р.
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Описание: This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations.

Автор: Lawrence X. Yu; Bing V. Li
Название: FDA Bioequivalence Standards
ISBN: 1493912518 ISBN-13(EAN): 9781493912513
Издательство: Springer
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Цена: 25155.00 р.
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Автор: Vinod P. Shah; Howard I. Maibach; John Jenner
Название: Topical Drug Bioavailability, Bioequivalence, and Penetration
ISBN: 1493912887 ISBN-13(EAN): 9781493912889
Издательство: Springer
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Цена: 22359.00 р.
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Описание: This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.

Автор: Patterson
Название: Bioequivalence and Statistics in Clinical Pharmacology
ISBN: 1584885300 ISBN-13(EAN): 9781584885306
Издательство: Taylor&Francis
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Цена: 13168.00 р.
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Описание: Bioequivalence and Statistics in Clinical Pharmacology covers the applications and basic elements of the theory of statistical methods in clinical pharmacology. It establishes techniques used in the assessment of bioequivalence and describes the use of statistics in clinical pharmacology studies of safety, ECG monitoring, efficacy, and population pharmacokinetics. The authors demonstrate study design, analysis, and interpretation of data using real data examples. The book emphasizes regulatory applications related to drug development and features a wide range of datasets as well as SAS and SPLUS code available on the Internet.

Автор: Lawrence X. Yu; Bing V. Li
Название: FDA Bioequivalence Standards
ISBN: 1493955586 ISBN-13(EAN): 9781493955589
Издательство: Springer
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Цена: 19564.00 р.
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Описание:

.- 1 Bioequivalence History

.- Alex Yu, Duxin Sun, Bing Li, and Lawrence X. Yu

.- 2 Fundamentals of Bioequivalence

.- Mei-Ling Chen

.- 3 Basic Statistical Considerations

.- Fairouz T. Makhlouf, Stella C. Grosser, Donald J. Schuirmann

.- 4 The Effects of Food on Drug Bioavailability and Bioequivalence

.- Wayne I. DeHaven and Dale P. Conner

.- 5 Biowaiver and Biopharmaceutics Classification System

.- Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, and Lawrence X. Yu

.- 6 Bioequivalence of Highly Variable Drugs

.- Barbara M. Davit and Devvrat T. Patel

.- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments

.- Hao Zhu, Ramana Uppoor, Mehul Mehta, and Lawrence X. Yu

.- 8 Bioequivalence for Narrow Therapeutic Index Drugs

.- Wenlei Jiang and Lawrence X. Yu

.- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies

.- Peng Zou and Lawrence X. Yu

.- 10 Clinical Endpoint Bioequivalence Study

.- John R Peters

Автор: Isadore Kanfer
Название: Bioequivalence Requirements in Various Global Jurisdictions
ISBN: 3319885421 ISBN-13(EAN): 9783319885421
Издательство: Springer
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Цена: 30745.00 р.
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Автор: Chaganti Subba Rao
Название: Cracking the Generics Code: Your Single-Source Success Manual for Winning in Multi-Source Product Markets!
ISBN: 9390211646 ISBN-13(EAN): 9789390211647
Издательство: Неизвестно
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Цена: 8267.00 р.
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Описание:

Cracking the Generics Code unravels the mystery of the DNA for success in the international generic drug markets.

Автор: Shargel, Leon , Kanfer, Isadore
Название: Generic Drug Product Development
ISBN: 0367384396 ISBN-13(EAN): 9780367384395
Издательство: Taylor&Francis
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Цена: 9798.00 р.
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Описание:

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives.

The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.

The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

Автор: Greene Jeremy A.
Название: Generic
ISBN: 142142164X ISBN-13(EAN): 9781421421643
Издательство: Неизвестно
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Цена: 5897.00 р.
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Описание: Greene`s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.