Design of Hybrid Molecules for Drug Development, Decker, Michael
Автор: Bonate Peter, Howard Danny Название: Pharmacokinetics in Drug Development / Clinical Study Design and Analysis (Volume 1) ISBN: 0971176744 ISBN-13(EAN): 9780971176744 Издательство: Springer Рейтинг: Цена: 204970.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. Geared toward graduate level students and scientists in the areas of clinical pharmacology and PK, the volumes will fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs, including first-time-in-man, biopharmaceuticals, and special population studies. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.
Автор: Indra K. Reddy, Reza Mehvar Название: Chirality in Drug Design and Development ISBN: 0824750624 ISBN-13(EAN): 9780824750626 Издательство: Taylor&Francis Рейтинг: Цена: 265410.00 T Наличие на складе: Невозможна поставка. Описание:
Covering every essential element in the development of chiral products, this reference provides a solid overview of the formulation, biopharmaceutical characteristics, and regulatory issues impacting the production of these pharmaceuticals. It supports researchers as they evaluate the pharmacodynamic, pharmacokinetic, and toxicological characteristics of specific enantiomers and chiral drug compounds and addresses in one convenient reference all the major challenges pertaining to drug chirality that have been neglected in the literature. Chirality in Drug Design and Development collects the latest studies from an interdisciplinary team of experts on chiral drug design.
State-of-the-Art Methods for Drug Safety Assessment
Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment.
The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation.
Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.
Автор: Abdel-Magid Название: Fundamentals of Early Clinical Drug Development - From Synthesis Design to Formulation ISBN: 0471692786 ISBN-13(EAN): 9780471692782 Издательство: Wiley Рейтинг: Цена: 147790.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: An informative look at the intricacies of today`s drug development process Once a discovery organization has identified a potential new drug candidate, it is the daunting task of synthetic organic chemists to identify the chemical process suitable for preparation of this compound in a highly regulated environment.
Автор: Zhang Название: Drug Metabolism in Drug Design and Development - Basic Concepts and Practice ISBN: 047173313X ISBN-13(EAN): 9780471733133 Издательство: Wiley Рейтинг: Цена: 150950.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Drug Metabolism in Drug Design and Development provides a practical description of what happens during the drug design and development process and focuses on issues such as: what data are needed; what experiments and analytical methods are typically employed; and how to interpret and apply data.
Автор: Wu-Pong Название: Biopharmaceutical Drug Design & Development.199 ISBN: 089603691X ISBN-13(EAN): 9780896036918 Издательство: Wiley Рейтинг: Цена: 83110.00 T Наличие на складе: Невозможна поставка.
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