Trends in Stability Testing, with Emphasis on Stability During Distribution and Storage
- 1 January 1999
- journal article
- review article
- Published by Taylor & Francis in Drug Development and Industrial Pharmacy
- Vol. 25 (7) , 857-868
- https://doi.org/10.1081/ddc-100102246
Abstract
This paper reviews contemporary trends in the stability testing of pharmaceutical products. In particular, it considers the progress toward globalization and harmonization and indicates stability problems, which probably will be the focus of attention for pharmaceutical scientists and regulators in the near future. Attention is specifically directed to monitoring stability in the channels of distribution.Keywords
This publication has 24 references indexed in Scilit:
- Rational Policies for Stability TestingClinical Research and Regulatory Affairs, 1993
- Storage Conditions for Stability Testing in the Ec, Japan and Usa; the Most Important Market for Drug ProductsDrug Development and Industrial Pharmacy, 1993
- Cyclic Temperature stress testing of pharmaceuticalsDrug Development and Industrial Pharmacy, 1992
- Degradation Kinetics of Thiamine Hydrochloride in Directly Compressed Tablets II: Reliability of Accelerated Stability Testing for Evaluating Tablet FormulationsDrug Development and Industrial Pharmacy, 1988
- Cyclic Testing in Stability ProgramsDrug Development and Industrial Pharmacy, 1986
- Statistical Prediction of Drug Stability Based on Nonlinear Parameter EstimationJournal of Pharmaceutical Sciences, 1984
- Statistical Treatment of Stability DataDrug Development and Industrial Pharmacy, 1981
- Terminology regarding labeled and contained amounts in dosage formsJournal of Pharmaceutical Sciences, 1976
- Use of Models in Determining Chemical Pharmaceutical StabilityJournal of Pharmaceutical Sciences, 1964
- Prediction of Stability of Drugs and Pharmaceutical PreparationsJournal of Pharmaceutical Sciences, 1962