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
) Z6 }$ D# E/ I/ Sis 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
9 D/ S, u) V7 y; d: uon the experience of the company or the individuals directing the studies. This
book provides readers with a single source reference that benchmarks the
; q& K' I! A" n5 N  }3 F) ?0 G8 lcurrent best practices of experienced pharmaceutical scientists/researchers.
4 ?; e7 R5 O9 _7 t7 V# E) \8 r* a) W, uQuestions like ‘‘How hot, how long, what conditions are appropriate?’’ and
- P1 W9 l. P0 p+ atopics such as mass balance, photostability, oxidative susceptibility, and the
4 Y! J. n' Q4 u' j( Z: x4 @chemistry of drug degradation are addressed in an objective, detailed scientific
) N5 a+ J) Z0 Z- k4 X: w" qmanner, with ample references to relevant guidances and the scientific literature.
+ W0 j5 ?% j) P" g( {% D6 T. bCompiling a book to be used as a scientific reference for the topic of
6 c- ]3 o, X* y2 S& a3 Dpharmaceutical stress testing was a daunting task. Stress testing, as it relates
  ?. l  C/ N7 {% h) K/ ato traditional small molecule pharmaceuticals, is very broad and scientifically
complex. Thus, this book seeks to be a practical and scientific guide
7 [, p" O$ A6 mwhich will, hopefully, stimulate new ideas and further development of the
science.
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.,
regulatory standardization) an area of pharmaceutical science that relies on
% R* `0 c& a. j5 [2 i: R. ]9 Sscientific expertise and flexibility. Each new drug compound, formulation,
' ^# I" o: Y( E, Hroute of administration, delivery device, etc. has the potential to present
" e$ V5 u' g( T; qunique 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
a useful and practical scientific guide that is a welcome addition to the
library of many pharmaceutical scientists. I am confident that the ‘‘artful
3 f% H; A9 \. k6 xscience’’ of stress testing will evolve beyond what is represented in this book
6 v  q" W0 J2 ?4 O! Kas other scientists further the science and fill in topics that are poorly covered
5 d, G" m: ^  r) t6 {! v3 jor missing.
" Q  m0 E; J  H

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