Pharmaceutical Stress Testing

Stress testing is the main tool that is used to predict stability problems,
! N) |4 e7 P4 i4 i7 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
9 [; P2 M1 {. C3 D. K: X, ^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.
- ^/ h9 {- k$ |5 C, X4 t5 lQuestions like ‘‘How hot, how long, what conditions are appropriate?’’ and
+ m, n+ R' ^7 i- q  }4 q4 b0 rtopics such as mass balance, photostability, oxidative susceptibility, and the
0 a! [5 A3 O6 d/ A3 q9 O2 O7 f6 Kchemistry of drug degradation are addressed in an objective, detailed scientific
manner, with ample references to relevant guidances and the scientific literature.
" G1 Z  N8 f. a: j5 X9 V1 MCompiling 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
" A+ ^) n+ @0 y8 |to traditional small molecule pharmaceuticals, is very broad and scientifically
complex. Thus, this book seeks to be a practical and scientific guide
4 N7 K" z4 u# h2 J4 ?) j2 d0 ~' }which will, hopefully, stimulate new ideas and further development of the
6 n2 K& s/ [$ H; U( [! Y. v( [  |science.
) z3 E+ ?6 E5 ]& H! G# h9 tThis undertaking is done with some trepidation, since I realize that discussion
of this topic could lead to attempts to formalize or standardize (i.e.,
. c. g% d" e) h! |! Vregulatory standardization) an area of pharmaceutical science that relies on
$ ?% X+ T1 R' F+ d8 {6 Dscientific expertise and flexibility. Each new drug compound, formulation,
route of administration, delivery device, etc. has the potential to present
& O: ^  }5 U& `- Ounique challenges and unanticipated problems, and should be approached
8 n0 b& A& z* W4 H( f* lwith such a mindset. The pharmaceutical researcher must be free to design
5 K4 `* y$ }7 t6 G8 Q0 ^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
% e" _$ ?5 n  S4 \1 n* M9 J$ rlibrary of many pharmaceutical scientists. I am confident that the ‘‘artful
science’’ of stress testing will evolve beyond what is represented in this book
% O: n2 ?3 q( [9 a1 e7 ^7 D  a* yas other scientists further the science and fill in topics that are poorly covered
% {1 ^2 W0 r. j3 Eor missing.
: t( q- x( m* [7 m5 [: a3 _

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