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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.
Buchkauf
Formulation and Analytical Development for Low-Dose Oral Drug Products, Jackey Zheng
- Sprache
- Erscheinungsdatum
- 2009
- product-detail.submit-box.info.binding
- (Hardcover)
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- Titel
- Formulation and Analytical Development for Low-Dose Oral Drug Products
- Sprache
- Englisch
- Autor*innen
- Jackey Zheng
- Verlag
- John Wiley & Sons,
- Erscheinungsdatum
- 2009
- Einband
- Hardcover
- ISBN10
- 0470056096
- ISBN13
- 9780470056097
- Reihe
- Schlagwörter
- Sachbücher, Lehrbücher, Medizin & Gesundheit, Medizin, Universitätslehrbücher
- Bewertung
- 5 von 5 Sternen
- Beschreibung
- 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.