Pharmaceutical Stress Testing

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
5 S; i8 v/ ^1 z! {& Tbook 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
% y7 {, A% N9 Jchemistry of drug degradation are addressed in an objective, detailed scientific
manner, with ample references to relevant guidances and the scientific literature.
9 |2 g3 d( g+ w( wCompiling 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
% m% H' L7 n. f4 e1 }) fwhich will, hopefully, stimulate new ideas and further development of the
7 ~( \* X; \' ?7 C1 j0 ~) vscience.
7 r) A% C9 B% g, {# nThis undertaking is done with some trepidation, since I realize that discussion
# h  X3 q, |( Z7 L( sof this topic could lead to attempts to formalize or standardize (i.e.,
6 U4 ?2 u+ {/ {# d4 V+ T$ u) u  `regulatory standardization) an area of pharmaceutical science that relies on
scientific expertise and flexibility. Each new drug compound, formulation,
7 C' ]! M) E7 S  O2 T, \route of administration, delivery device, etc. has the potential to present
* \+ `& c: w( munique challenges and unanticipated problems, and should be approached
with such a mindset. The pharmaceutical researcher must be free to design
9 Z2 j" d" ~9 Hand develop new ways to predict and measure stability-related issues
through stress testing. Nonetheless, it is hoped that this book will provide
& u0 p8 ~5 _* [2 G7 x$ ca useful and practical scientific guide that is a welcome addition to the
- J/ ]$ u4 H; rlibrary of many pharmaceutical scientists. I am confident that the ‘‘artful
science’’ of stress testing will evolve beyond what is represented in this book
. `0 X; e  B, z9 ras other scientists further the science and fill in topics that are poorly covered
or missing.
# Z- W: m" G  k+ L, D

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