Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition, Chow

Автор: Chow
Название: Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition BABE-Solution bundle version
ISBN: 1439813582 ISBN-13(EAN): 9781439813584
Издательство: Taylor&Francis
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Цена: 230700.00 T
Наличие на складе: Поставка под заказ.
Описание: Containing four new chapters, along with several new and updated sections, this third edition reviews the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. It presents the current status of regulations on bioavailability and bioequivalence, including guidelines/guidances issued by the FDA, EMEA, and WHO. This edition addresses frequently asked questions and explores sample size determination, meta-analysis, and pharmacokinetics. It also offers a basic version of PharmaSoftware Solutions, Inc.’s BABE Solution 2008, with bioequivalence assessment for in vivo bioequivalence studies.

Автор: El-Kattan
Название: Oral Bioavailability Assessment: Basics and Strate gies for Drug Discovery and Development
ISBN: 1118916697 ISBN-13(EAN): 9781118916698
Издательство: Wiley
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Цена: 154120.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Specifically geared to personnel in the pharmaceutical and biotechnology industries, this book describes the basics and challenges of oral bioavailability one of the most significant hurdles in drug discovery and development.

Автор: Niazi Sarfaraz K
Название: Handbook Of Bioequivalence Testing
ISBN: 0849303958 ISBN-13(EAN): 9780849303951
Издательство: Taylor&Francis
Цена: 153120.00 T
Наличие на складе: Поставка под заказ.
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: Niazi
Название: Handbook Bioequivalence Testing 2E
ISBN: 1482226375 ISBN-13(EAN): 9781482226379
Издательство: Taylor&Francis
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Цена: 193950.00 T
Наличие на складе: Невозможна поставка.
Описание: This year`s session was marked by substantial steps forward to support the reform process launched in 2009 with the aim to modernise the institutional framework and ensure a more efficient functioning of the commission. In addition the session adopted guidelines on precautionary conservation measures aimed at minimizing undesirable effects on stocks and improving fisheries economic profitability.

Автор: Patterson
Название: Bioequivalence and Statistics in Clinical Pharmacology
ISBN: 1584885300 ISBN-13(EAN): 9781584885306
Издательство: Taylor&Francis
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Цена: 87790.00 T
Наличие на складе: Поставка под заказ.
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.