A Stress Testing Benchmarking Study

  title={A Stress Testing Benchmarking Study},
  author={Karen M. Alsante and Linda Lin Martin and Steven W. Baertschi},
portant part of the drug development process, and the pharmaceutical industry’s considerable interest in this topic has led to the publication of an article by the Pharmaceutical Research and Manufacturer’s of America (PhRMA) in Pharmaceutical Technology (1). Although the concept of stress testing is not new to the pharmaceutical industry, the procedure was not clearly defined until the International Conference on Harmonization (ICH) provided a definition in its guidance on stability. The ICH… CONTINUE READING


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Available Guidance and Best Practices for Conducting Forced Degradation Studies,

D. W. Reynolds
Pharm. Technol • 2002

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