标题: Pharmaceutical Stress Testing [打印本页] 作者: lookspace 时间: 2014-8-1 08:43 AM 标题: Pharmaceutical Stress Testing Stress testing is the main tool that is used to predict stability problems, 6 i0 S9 b7 i9 K- b& d6 pdevelop analytical methods, and identify degradation products/pathways., p9 ~' P6 I _5 `$ {
Since there are no detailed regulatory guidelines that direct how stress testing; c9 @' Y, o; W: L
is to be done, nor has there ever been a text/reference book on the : x5 u3 M: v) ~8 U- q" F4 J$ Usubject, stress testing has evolved into an artful science that is highly dependent" P& W! |, Y: d( ~
on the experience of the company or the individuals directing the studies. This* R% N3 l6 }, {% a5 x; b
book provides readers with a single source reference that benchmarks the @1 V, o" o' [$ H/ n( B
current best practices of experienced pharmaceutical scientists/researchers.5 U1 A/ G* o8 _" ]+ o' V4 v8 d
Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and! A1 r8 I! A" X
topics such as mass balance, photostability, oxidative susceptibility, and the 5 M/ H a- X6 h+ C( u! r0 |chemistry of drug degradation are addressed in an objective, detailed scientific7 Q/ M( j* V3 S9 D5 `4 }5 S
manner, with ample references to relevant guidances and the scientific literature.$ F. R" c! O6 D4 e: e% G
Compiling a book to be used as a scientific reference for the topic of8 V0 w# M8 @9 B9 y, e
pharmaceutical stress testing was a daunting task. Stress testing, as it relates 0 K0 I5 v5 O. Oto traditional small molecule pharmaceuticals, is very broad and scientifically % i9 B. Q9 a9 V6 e7 c+ ~complex. Thus, this book seeks to be a practical and scientific guide * ~ o7 L- C8 m7 Q- b2 @7 Q0 _which will, hopefully, stimulate new ideas and further development of the : h* P# a! p9 Z4 r( k+ C( x1 G7 Zscience.7 j8 }4 A8 X, R; I
This undertaking is done with some trepidation, since I realize that discussion # U1 s m, J2 D' K o* Oof this topic could lead to attempts to formalize or standardize (i.e., 0 b( [4 h" k2 s" p& r* N2 iregulatory standardization) an area of pharmaceutical science that relies on 4 y; k& h( w8 f: X( Pscientific expertise and flexibility. Each new drug compound, formulation, - n7 i+ r ^, Q+ e- J3 f: k+ Oroute of administration, delivery device, etc. has the potential to present S& k' W) B1 K5 q
unique challenges and unanticipated problems, and should be approached3 T/ t' `7 d2 p0 l) y+ c& y) ^) c
with such a mindset. The pharmaceutical researcher must be free to design . u2 l/ D# f1 j, D) Vand develop new ways to predict and measure stability-related issues' A, p) r! q! a. i* ~& F: l/ ?
through stress testing. Nonetheless, it is hoped that this book will provide+ I0 M k+ o7 u- X
a useful and practical scientific guide that is a welcome addition to the! N& J p% H. u) n. ?: h& O
library of many pharmaceutical scientists. I am confident that the ‘‘artful ! v' B0 g! ]" @2 ?1 ]science’’ of stress testing will evolve beyond what is represented in this book % c! P# W& E4 A7 T: N+ Las other scientists further the science and fill in topics that are poorly covered6 ?. R, l% M+ S n
or missing.7 x8 I* Y# o0 G! X' B+ n
6 t3 @* G1 u7 E. y作者: 一场梦 时间: 2014-8-1 09:06 AM
呜呜呜呜 ，英语烂的我只有哭了哈作者: houfangjie1984 时间: 2014-8-1 09:17 AM
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？作者: bomengr 时间: 2014-8-1 09:20 AM
看了我头好大作者: 风流令狐冲 时间: 2014-8-1 01:02 PM
顶一下 只是英文不太好
