Drug Synergism and Dose-Effect Data Analysis, Tallarida, Ronald J.
Автор: Ronald J. Tallarida; Leonard S. Jacob Название: The Dose—Response Relation in Pharmacology ISBN: 1468462679 ISBN-13(EAN): 9781468462678 Издательство: Springer Рейтинг: Цена: 6986.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Another line of investigation is concerned with the kinetic theories of drug-receptor interaction, the effort there being to provide a general theory that is applicable to wide classes of drugs. Second, many students fail to appreciate the differences in and the limitations of the various theories, beginning with the classical theory of A.
Автор: Naitee Ting Название: Dose Finding in Drug Development ISBN: 144192115X ISBN-13(EAN): 9781441921154 Издательство: Springer Рейтинг: Цена: 20896.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. It introduces the drug development process and explains the practical concerns in selecting doses for a new drug.
Автор: Pazhayattil Ajay Babu, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija Название: Solid Oral Dose Process Validation: The Basics, Volume 1 ISBN: 3030024717 ISBN-13(EAN): 9783030024710 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
Автор: Pazhayattil Ajay, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija Название: Solid Oral Dose Process Validation, Volume Two: Lifecycle Approach Application ISBN: 3030274837 ISBN-13(EAN): 9783030274832 Издательство: Springer Рейтинг: Цена: 11878.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.
Описание: Optimal dose individualization has become more important in improving clinical efficacy and safety. Therefore, the role of optimal dose finding in early clinical drug development so as to maximize successful clinical use is emphasized.
Описание: Naltrexone is an opiate antagonist drug developed in the 1970s and approved by the FDA in 1984 as a safe and effective treatment for opiate and drug abuse. This book describes the history of naltrexone, including its potential therapeutic uses, its effects on the immune system, and its pharmacological properties.
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