Pharmaceutical Stress Testing

Stress testing is the main tool that is used to predict stability problems,
+ y9 |% p2 m9 P4 \; ?& r* A4 S; z- qdevelop analytical methods, and identify degradation products/pathways.
Since there are no detailed regulatory guidelines that direct how stress testing
% E& k, {$ L1 ^4 X: U4 k7 Cis 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
, x$ ?+ y8 u% s  Kbook provides readers with a single source reference that benchmarks the
6 ]3 `2 R, |: X! d! ?. F0 A* Dcurrent best practices of experienced pharmaceutical scientists/researchers.
Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and
9 N' n+ g; Z- Q  I5 qtopics such as mass balance, photostability, oxidative susceptibility, and the
* G" s6 X+ I+ Ichemistry 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
* W+ a$ r( U; o  w, Cpharmaceutical stress testing was a daunting task. Stress testing, as it relates
to traditional small molecule pharmaceuticals, is very broad and scientifically
* B+ P# @7 @/ Y1 x9 U$ l1 v6 Tcomplex. Thus, this book seeks to be a practical and scientific guide
which will, hopefully, stimulate new ideas and further development of the
9 {( R; D4 @- _) k: Z9 Zscience.
) w, F6 \0 y) _& j% P4 D3 V1 FThis undertaking is done with some trepidation, since I realize that discussion
' e! R8 m* l& b1 yof this topic could lead to attempts to formalize or standardize (i.e.,
regulatory standardization) an area of pharmaceutical science that relies on
% K& n( k- K4 `( K' l+ E% E: r# m, z8 [scientific expertise and flexibility. Each new drug compound, formulation,
- Z) O" m# U) l8 droute of administration, delivery device, etc. has the potential to present
unique challenges and unanticipated problems, and should be approached
6 m  V, m: `  F- P7 T. E0 @with such a mindset. The pharmaceutical researcher must be free to design
* m8 E, U; ~2 ~9 Zand develop new ways to predict and measure stability-related issues
# d9 T+ g# P% D2 ^- R9 s- O; \$ Athrough stress testing. Nonetheless, it is hoped that this book will provide
+ a: Y) j5 N0 ^/ S  K: h: Ka useful and practical scientific guide that is a welcome addition to the
" ]' J0 p4 g9 q1 t4 Ilibrary of many pharmaceutical scientists. I am confident that the ‘‘artful
% o) u) ]+ W3 v, kscience’’ 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
7 S' ?) H" L/ r# S. K0 m: E  j7 Sor missing.
1 s) c2 Q. N& d, K0 J# K

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