Drug stability

Drug stability: principles and practices

by Carstensen, Jens Thurø Rhodes, Christopher Thomas

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Title Statements

  • Full title :Drug stability : principles and practices / ed. by Jens T. Carstensen, C.T. Rhodes.

Edition Statements

  • Publication Date:2000.
  • Edition:3rd edition rev. and expanded

Publication Statements

  • Publisher(s):M. Dekker
  • Place of Publication:New York
  • Language:eng
  • Publication Date:2000.

Notes

Previous editions cataloged under: Cartensen, Jens Thurø, 1926- Drug stability.

The Physical Object

  • Description:1 vol. (VII-773 p.) : : ill. ; : 24 cm.

Edition Identifiers

  • ISBN:9780824703769, 0824703766
  • oclc:ocn490757807
  • LC Classification:RS424
  • Dewey Decimal:615/.18

Table of Contents

Introductory overview -- Solution kinetics -- Kinetic pH profiles -- Oxidation in solution -- Catalysis, complexation, and photolysis -- Solid state stability -- Interactions of moisture with solids -- Physical characteristics of solids -- Performulation -- Physical testing -- Development and validation of HPLC stability-indicationg assays -- Stability testing of clinical trial materials -- A rational approach to stability testing and analytical development for NCE, drug substance, and drug products: marketed product stability testing -- Packaging, package evaluation, stability, and shelf-life -- Industrial stability testing in the United States and computerization of stability data -- Stability of polypeptides and proteins -- Regulatory aspects of stability testing in Europe -- Regulatory and scientific aspects of stability testing: present and possible future trends -- Appn.: Guidance for industry: stability testing of drug substances and drug products (draft).

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Subjects

Drug Stability Médicaments -- Stabilité Stabilité de médicament

Writers

Carstensen, Jens Thurø Rhodes, Christopher Thomas

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