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Al-Achi, Antoine

Integrated Pharmaceutics: Applied Preformulation, Product Design, and Regulatory Science

Al-Achi, Antoine - Integrated Pharmaceutics: Applied Preformulation, Product Design, and Regulatory Science, ebook

134,70€

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ISBN: 9781118356715
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Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.

Keywords: Drug Formulation & Delivery, Integrated Pharmaceutics, Antoine Al-Achi, Mali Ram Gupta, William Stagner, quality by design, process analytical technology, polymorphism characterization, stability protocols, biopharmaceutical classification system, Dosage Forms, Product Design, Preformulation, Regulatory Science, Pharmaceutics, Industrial Pharmacy, Physical Pharmacy, Compounding, Pharmaceutical Regulations, Process Validation, Pharmaceutical Statistics, Design of Experiments, Quality Systems, Drug Approval Processes, NDA filing and approval, ANDA approval, Generic Drug Approval, Biosimilar Drugs

Author(s)
 
 
Publisher
John Wiley and Sons, Inc.
Publication year
2013
Language
en
Edition
1
Page amount
1016 pages
Category
Natural Sciences
Format
Ebook
eISBN (PDF)
9781118356715
Printed ISBN
9780470596920

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