[实验研究与计划] Pharmaceutical Stress Testing

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电梯直达

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lookspace 发表于 2014-8-1 08:43:18 | 只看该作者回帖奖励

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Stress testing is the main tool that is used to predict stability problems,
develop analytical methods, and identify degradation products/pathways.
Since there are no detailed regulatory guidelines that direct how stress testing
is to be done, nor has there ever been a text/reference book on the
subject, stress testing has evolved into an artful science that is highly dependent
on the experience of the company or the individuals directing the studies. This
book provides readers with a single source reference that benchmarks the
current best practices of experienced pharmaceutical scientists/researchers.
Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and
topics such as mass balance, photostability, oxidative susceptibility, and the
chemistry of drug degradation are addressed in an objective, detailed scientific
manner, with ample references to relevant guidances and the scientific literature.
Compiling a book to be used as a scientific reference for the topic of
pharmaceutical stress testing was a daunting task. Stress testing, as it relates
to traditional small molecule pharmaceuticals, is very broad and scientifically
complex. Thus, this book seeks to be a practical and scientific guide
which will, hopefully, stimulate new ideas and further development of the
science.
This undertaking is done with some trepidation, since I realize that discussion
of this topic could lead to attempts to formalize or standardize (i.e.,
regulatory standardization) an area of pharmaceutical science that relies on
scientific expertise and flexibility. Each new drug compound, formulation,
route of administration, delivery device, etc. has the potential to present
unique challenges and unanticipated problems, and should be approached
with such a mindset. The pharmaceutical researcher must be free to design
and develop new ways to predict and measure stability-related issues
through stress testing. Nonetheless, it is hoped that this book will provide
a useful and practical scientific guide that is a welcome addition to the
library of many pharmaceutical scientists. I am confident that the ‘‘artful
science’’ of stress testing will evolve beyond what is represented in this book
as other scientists further the science and fill in topics that are poorly covered
or missing.