ISBN: 9783030274832
Код товара 143677
Solid Oral Dose Process Validation, Volume Two: Lifecycle Approach Application
ISBN: 9783030274832
Код товара 143677
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Если Вы закажете книгу до 15.04.2024, то мы привезём её ориентировочно 05.06.2024.
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Автор
Pazhayattil Ajay, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija
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Издатель
Springer
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Тип обложки
Hardcover
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Размеры
234 x 156 x 8
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Год издания
2019
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Вес (г)
349
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ISBN
9783030274832
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Язык
ENG
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Кол-во страниц
108
О чём книга?
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.
Preface, Introduction, Chapter 1: Stage 1 Quality by Design Product Development QbD product development methodologies.- Chapter 2: Stage 1 Scale Up, Tech Transfer Process.- Considerations for process scale up and transfer.- Chapter 3: Stage 2 Batch determ
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