Burdick Richard K., Leblond David J., Pfahler Lori B. Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry 9783319843384

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Автор: Burdick Richard K., Leblond David J., Pfahler Lori B.
Название: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
ISBN: 9783319843384
Издательство: Springer
Классификация:

Аптечная служба и отпуск лекарственных средств

Вероятность и статистика

Промышленная химия

Технологии производства фармацевтических препаратов

ISBN-10: 3319843389
Обложка/Формат: Paperback
Страницы: 379
Вес: 0.55 кг.
Дата издания: 04.05.2018
Серия: Statistics for biology and health
Язык: English
Издание: Softcover reprint of
Иллюстрации: 68 tables, color; 80 illustrations, color; 33 illustrations, black and white; xi, 379 p. 113 illus., 80 illus. in color.; 68 tables, color; 80 illustr
Размер: 234 x 156 x 21
Читательская аудитория: General (us: trade)
Ссылка на Издательство: Link
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Поставляется из: Германии
Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
Дополнительное описание: Chapter 1. Introduction.- Chapter 2. Statistical Methods for CMC Applications.- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance.- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance.- Chapter 5. GMP M

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry, Burdick Richard K., Leblond David J., Pfahler Lori B.