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,+ {" X$ {( ]3 S1 E) W$ B
develop analytical methods, and identify degradation products/pathways. % Q# j$ _8 Y }( m+ C0 n% ZSince there are no detailed regulatory guidelines that direct how stress testing+ S# s5 ~( o" G: V. ^: ? ?
is to be done, nor has there ever been a text/reference book on the! v x) N$ K: u) p
subject, stress testing has evolved into an artful science that is highly dependent $ f9 u/ V+ S* W @4 j3 mon the experience of the company or the individuals directing the studies. This) k; L7 ~* O- i/ s5 p
book provides readers with a single source reference that benchmarks the ; Z: b$ B$ J y" r9 W1 X" W- gcurrent best practices of experienced pharmaceutical scientists/researchers. 0 ?7 m& u2 W5 l- @" [' {2 c; U0 GQuestions like ‘‘How hot, how long, what conditions are appropriate?’’ and # R9 |1 d: B4 s- B0 @topics such as mass balance, photostability, oxidative susceptibility, and the % B5 o2 }' ~- |1 U, {. g9 i" Wchemistry of drug degradation are addressed in an objective, detailed scientific & }) v4 r) B) `% n# }$ F* J8 imanner, with ample references to relevant guidances and the scientific literature. 7 Y: D: h( L3 wCompiling a book to be used as a scientific reference for the topic of 7 m: d, N$ Y6 A& B4 X! d ^pharmaceutical stress testing was a daunting task. Stress testing, as it relates + x) i0 G6 `; K' s& P! Rto traditional small molecule pharmaceuticals, is very broad and scientifically7 T. L; |3 a% o* l/ s9 W
complex. Thus, this book seeks to be a practical and scientific guide+ ^. }1 O7 K* x- t: z- {( q
which will, hopefully, stimulate new ideas and further development of the, d4 H9 O, J* A; @6 }
science. % J9 N ]! Q4 E8 qThis undertaking is done with some trepidation, since I realize that discussion9 v' w* m2 g1 l
of this topic could lead to attempts to formalize or standardize (i.e., 4 t. Y7 n! }4 [0 Y9 l8 \( @2 \regulatory standardization) an area of pharmaceutical science that relies on 4 W! M- I$ l6 tscientific expertise and flexibility. Each new drug compound, formulation, . I% a; `1 ~! i. ?' K- hroute of administration, delivery device, etc. has the potential to present ) j S$ B2 S; J1 u! i; S; X; Q/ bunique challenges and unanticipated problems, and should be approached* h1 K) k0 l0 y5 o4 @
with such a mindset. The pharmaceutical researcher must be free to design4 c. c6 c* g* h5 c- R; f
and develop new ways to predict and measure stability-related issues% A7 e0 w8 V5 X4 q9 t
through stress testing. Nonetheless, it is hoped that this book will provide% K: y7 A0 |2 w( |( i- H
a useful and practical scientific guide that is a welcome addition to the3 Z- \$ Z! r* I/ k
library of many pharmaceutical scientists. I am confident that the ‘‘artful, G. p+ ?7 b4 ~: U2 ]' \
science’’ of stress testing will evolve beyond what is represented in this book 1 s- n4 j$ ~$ C, X6 ?% Sas other scientists further the science and fill in topics that are poorly covered, D1 D2 m7 Q& F' B( b# ^
or missing.% l+ Z+ r; v6 \* M
