Pharmaceutical Stress Testing

Stress testing is the main tool that is used to predict stability problems,
  K$ n; W, _- X% Gdevelop analytical methods, and identify degradation products/pathways.
Since there are no detailed regulatory guidelines that direct how stress testing
% @% J- n2 k8 @" z1 h, Xis to be done, nor has there ever been a text/reference book on the
4 n2 d+ _/ h) }+ I% m- B' [subject, stress testing has evolved into an artful science that is highly dependent
7 S4 k. T/ L4 J$ J- d. l3 }9 fon the experience of the company or the individuals directing the studies. This
- M. r0 p3 j5 Y; D$ b  Ibook provides readers with a single source reference that benchmarks the
current best practices of experienced pharmaceutical scientists/researchers.
& {" Y/ b2 K! o% W4 r$ V2 rQuestions like ‘‘How hot, how long, what conditions are appropriate?’’ and
* M% L8 t4 W0 f; e+ J2 Otopics such as mass balance, photostability, oxidative susceptibility, and the
chemistry of drug degradation are addressed in an objective, detailed scientific
& G7 I, R# Y, K) u$ c* A  Smanner, 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
( V4 W3 Z8 V6 Eto traditional small molecule pharmaceuticals, is very broad and scientifically
+ G. c) U3 v4 m* E, [8 ecomplex. Thus, this book seeks to be a practical and scientific guide
! ]8 P4 R3 r( B% v6 H- E7 [0 Vwhich will, hopefully, stimulate new ideas and further development of the
% c6 o  J) C, |! m' Oscience.
. f6 n2 v0 S6 W, A0 qThis 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
scientific expertise and flexibility. Each new drug compound, formulation,
route of administration, delivery device, etc. has the potential to present
7 G. v9 _" v8 {/ }  s( }- L2 c* yunique challenges and unanticipated problems, and should be approached
with such a mindset. The pharmaceutical researcher must be free to design
/ O7 F, n" H& W5 Q3 b& nand develop new ways to predict and measure stability-related issues
1 |6 F' q, M* w, b* c2 B8 Athrough stress testing. Nonetheless, it is hoped that this book will provide
' {! S; l" q2 j1 e$ w  ra useful and practical scientific guide that is a welcome addition to the
library of many pharmaceutical scientists. I am confident that the ‘‘artful
7 ^9 v! d9 j- n* d# yscience’’ of stress testing will evolve beyond what is represented in this book
" R3 v8 C& r. B- n2 m6 a. x" _as other scientists further the science and fill in topics that are poorly covered
2 W( n5 d: R6 {: F$ S; c% W4 Sor missing.

, j5 F9 ~6 j# [5 D% a

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