Pharmaceutical Stress Testing

Stress testing is the main tool that is used to predict stability problems,
. x  Z5 h2 s1 q9 n  Udevelop analytical methods, and identify degradation products/pathways.
/ ~8 z8 ^5 s1 v) C  [* Y0 [Since there are no detailed regulatory guidelines that direct how stress testing
: q8 L- ^' s9 Zis to be done, nor has there ever been a text/reference book on the
3 {0 `, E9 F5 j. o% E7 u6 Zsubject, 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
! f7 L1 k1 u# N/ i5 ~0 l8 F( sbook provides readers with a single source reference that benchmarks the
current best practices of experienced pharmaceutical scientists/researchers.
2 W: `  U0 E1 ~7 Q' J" H  \Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and
0 q9 i- ^* n+ I& c: ]topics such as mass balance, photostability, oxidative susceptibility, and the
chemistry of drug degradation are addressed in an objective, detailed scientific
, U0 D* c* k1 d% E2 Wmanner, 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
7 N2 e: B" n1 |( a3 o! O* z$ Uto traditional small molecule pharmaceuticals, is very broad and scientifically
* a* f! H) _$ R& V6 ncomplex. Thus, this book seeks to be a practical and scientific guide
which will, hopefully, stimulate new ideas and further development of the
$ b; ^8 _1 [* g. T" B0 }science.
" M. R2 v4 E5 Y& N! K8 T' [, ?This undertaking is done with some trepidation, since I realize that discussion
4 Z  c# B7 X& J( b! y2 J8 p9 kof this topic could lead to attempts to formalize or standardize (i.e.,
+ R8 W1 u- p. o2 S, {" Q$ Wregulatory 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
' G: t, R+ l( P! C% y+ ounique challenges and unanticipated problems, and should be approached
  J% q  K+ {: E& ^with such a mindset. The pharmaceutical researcher must be free to design
7 D3 a! V4 e" Y! ?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
# G2 `4 F! w6 s2 ~library of many pharmaceutical scientists. I am confident that the ‘‘artful
science’’ of stress testing will evolve beyond what is represented in this book
, c: y0 L1 Q5 |/ Mas other scientists further the science and fill in topics that are poorly covered
% v7 B. S: [4 ]* c8 Por missing.
# d* x7 ~4 \* K" s1 `
3 |& o. p- W' n0 L; P8 C4 b

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