International Stability Testing

Buch | Hardcover

350 Seiten

1998
Crc Press Inc (Verlag)
978-1-57491-078-0 (ISBN)

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In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.

David J. Mazzo

ICH Stability Guidelines. Photostability Testing. ICH Guidelines for Biological & Biotechnological Products. Stress Testing: Drug Substance Characterization. Statistical & Regulatory Aspects: FDA Perspective. Matrixing & Bracketing Designs: European Perspective. Preservative Activity During Studies. Substances Solid-State Characterization & Stability. Europe: Requirements. Postapproval FDA Requirements. Japan. Australia. WHO. Non-ICH Areas.

Erscheint lt. Verlag	31.8.1998
Verlagsort	Bosa Roca
Sprache	englisch
Maße	178 x 254 mm
Gewicht	810 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pflege
	Medizin / Pharmazie ► Pharmazie ► PTA / PKA
ISBN-10	1-57491-078-7 / 1574910787
ISBN-13	978-1-57491-078-0 / 9781574910780
Zustand	Neuware