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There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
Acquisto del libro
Formulation and Analytical Development for Low-Dose Oral Drug Products, Jackey Zheng
- Lingua
- Pubblicato
- 2009
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- (Copertina rigida)
Metodi di pagamento
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- Titolo
- Formulation and Analytical Development for Low-Dose Oral Drug Products
- Lingua
- Inglese
- Autori
- Jackey Zheng
- Editore
- John Wiley & Sons,
- Pubblicato
- 2009
- Formato
- Copertina rigida
- ISBN10
- 0470056096
- ISBN13
- 9780470056097
- Serie
- Valutazione
- 5 su 5
- Descrizione
- There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.