Pharmaceutical Stress Testing

Stress testing is the main tool that is used to predict stability problems,
' I( ?8 P; p& `3 Mdevelop 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
3 t2 u& R8 m6 N$ o# J( [' x5 |2 Csubject, stress testing has evolved into an artful science that is highly dependent
# f# B6 @4 B  X$ y% Z0 y2 E% gon the experience of the company or the individuals directing the studies. This
& m' n8 u6 d0 e+ S) J) p: qbook provides readers with a single source reference that benchmarks the
current best practices of experienced pharmaceutical scientists/researchers.
6 n$ j5 Q4 _5 B3 ]Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and
3 z) t( \, I- Vtopics such as mass balance, photostability, oxidative susceptibility, and the
  A; _4 Y- N! u% Y1 a0 }, Jchemistry of drug degradation are addressed in an objective, detailed scientific
' B) E; o  k% ]/ f& v" A, c, d6 Bmanner, 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
$ h+ }. a& m1 G( Z5 T& K% c/ Hto traditional small molecule pharmaceuticals, is very broad and scientifically
complex. Thus, this book seeks to be a practical and scientific guide
. z' }; f% p3 P. l$ O4 wwhich will, hopefully, stimulate new ideas and further development of the
( O5 q% A9 ?' _' g9 R8 tscience.
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.,
( W1 r, y! c( h$ m# H! Vregulatory standardization) an area of pharmaceutical science that relies on
0 Z$ A( M: K0 t7 ?scientific expertise and flexibility. Each new drug compound, formulation,
3 k6 j6 _; b% {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
2 I3 F: e" x' Na useful and practical scientific guide that is a welcome addition to the
" A! R; `% ]& j+ e1 w% Rlibrary of many pharmaceutical scientists. I am confident that the ‘‘artful
8 V  x( `3 ?, C: l! k" rscience’’ of stress testing will evolve beyond what is represented in this book
- ^( x1 ^/ r$ c. ^as other scientists further the science and fill in topics that are poorly covered
  `, H0 G3 g) K3 Por missing.

呜呜呜呜  ，英语烂的我只有哭了哈

楼主高大上。刚看前俩词我以为是个测试，读完发现是本书，貌似还不粗的书，我理解的对吗？

看了我头好大

顶一下 只是英文不太好