Drug Stability

Principles and Practices

Jens Thuro Carstensen (Autor)

Buch | Hardcover

616 Seiten

1995 | 2nd Revised edition
Marcel Dekker Inc (Verlag)
978-0-8247-9635-8 (ISBN)

Infos

This work combines basic theory, current industrial practice and useful regulatory aspects in an overview of pharmaceutical stability. Details new to this edition include information on the effect micro-environmental pH has on the stability and behaviour of solid-drug substances.

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This work combines basic theory, current industrial practice and useful regulatory aspects in an overview of pharmaceutical stability. It examines data analysis of packaged drug's stability, experimental methods for achieving stable marketed products and the stability principles of drugs in dissolved, dispersed and solid states. This second edition: presents new information on the effect micro-environmental pH has on the stability and behaviour of solid-drug substances; discusses the advantages and limitations of harmonization; features updated coverage of computer programs for determining the stability function; and more.

Inhalt

Overview; Solution Kinetics; Kinetic pH Profiles; Oxidation in Solution; Catalysis, Complexation and Photolysis; Stability of Peptides and Proteins; Disperse and Aggregated Systems; Physical Characteristics of Solids; Solid State Stability; Interactions of Moisture with Solids; Statistical Aspects; Preformulation; Packaging; Physical Testing; Modus Operandi for a Stability Program; 1993 ICH Guidelines; 1987 FDA Stability Guideline.

Produkt-Details

• Reihe/Serie: Drugs and the Pharmaceutical Sciences ; v. 68
• Zusatzinfo: illustrations
• Verlagsort: New York
• Sprache: englisch
• Maße: 165 x 241 mm
• Gewicht: 953 g
• Themenwelt: Technik
• ISBN-10: 0-8247-9635-7 / 0824796357
• ISBN-13: 978-0-8247-9635-8 / 9780824796358
• Zustand: Neuware