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,$ ?5 D4 |: b2 O3 P! ?( @
develop analytical methods, and identify degradation products/pathways.+ x n6 F7 \5 U% B
Since there are no detailed regulatory guidelines that direct how stress testing9 u# j0 F4 v M
is to be done, nor has there ever been a text/reference book on the 1 a3 \0 I8 Q( a% q# z8 j8 [1 h4 D# ]subject, stress testing has evolved into an artful science that is highly dependent, S! {+ k9 q! m- c2 c9 p* n
on the experience of the company or the individuals directing the studies. This5 i/ \6 }, S: s
book provides readers with a single source reference that benchmarks the: q3 ^& x8 i& N
current best practices of experienced pharmaceutical scientists/researchers.1 f6 o, [( S9 B7 U
Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and 4 h, L0 D# W1 r# n( u3 R* I: atopics such as mass balance, photostability, oxidative susceptibility, and the; R! ]. a$ B! C
chemistry of drug degradation are addressed in an objective, detailed scientific6 {# r* |$ @% D, e
manner, with ample references to relevant guidances and the scientific literature. 6 D& _% Y& L! JCompiling a book to be used as a scientific reference for the topic of9 C2 T' o) }* Q2 c+ f
pharmaceutical stress testing was a daunting task. Stress testing, as it relates' v. S* F3 ^& F7 |
to traditional small molecule pharmaceuticals, is very broad and scientifically 1 u& ?9 X1 K: K$ `% P+ bcomplex. Thus, this book seeks to be a practical and scientific guide( m7 E3 W3 ^; l+ z( v7 u* J
which will, hopefully, stimulate new ideas and further development of the : V" ?0 ^# g% m: E& wscience. / }' }2 @) |5 F( W5 Z* wThis undertaking is done with some trepidation, since I realize that discussion" {- ?8 m. M$ B: `
of this topic could lead to attempts to formalize or standardize (i.e.,1 p6 ?" v2 Y2 j, S+ ~
regulatory standardization) an area of pharmaceutical science that relies on / k6 ^* i2 \5 _( \8 w; h% H0 ^9 ^# ^scientific expertise and flexibility. Each new drug compound, formulation,- o" C- V% C' `' _! A7 J
route of administration, delivery device, etc. has the potential to present' D) H G& R% [3 g( q; h
unique challenges and unanticipated problems, and should be approached8 X2 m$ F' a# j+ W( }& A
with such a mindset. The pharmaceutical researcher must be free to design 3 W3 h9 Y: ^- O1 Oand develop new ways to predict and measure stability-related issues# m1 |3 X5 z, ^, o( Y/ F4 `
through stress testing. Nonetheless, it is hoped that this book will provide% ^4 m2 U4 T3 ` W2 R, b! f
a useful and practical scientific guide that is a welcome addition to the) x$ u1 c x2 J' N. v u
library of many pharmaceutical scientists. I am confident that the ‘‘artful4 R- C8 u% G: v( e: Z
science’’ of stress testing will evolve beyond what is represented in this book! B! C% V4 Z) F( a3 H& M# t7 @
as other scientists further the science and fill in topics that are poorly covered3 J# `' k- W* o" `$ M+ C. B
or missing.- n, x% N# Y8 Z* W
; p" b5 H `9 I% V 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
