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, E$ V2 p6 L; E% l3 K! f5 |
develop analytical methods, and identify degradation products/pathways.- O6 o, _% @ r0 |# E
Since there are no detailed regulatory guidelines that direct how stress testing 3 X4 y9 i( u0 k! i# h( {; I" [is to be done, nor has there ever been a text/reference book on the e* z- t0 P9 t) O1 q
subject, stress testing has evolved into an artful science that is highly dependent 8 e" G8 l- u9 J' E% Y4 won the experience of the company or the individuals directing the studies. This $ \* S+ |5 [: e6 Q& gbook provides readers with a single source reference that benchmarks the; [7 t! i/ s7 L
current best practices of experienced pharmaceutical scientists/researchers.+ v3 f m q Q; M
Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and . f8 R7 B' k6 @topics such as mass balance, photostability, oxidative susceptibility, and the # O; d2 m: P; `. ?6 lchemistry of drug degradation are addressed in an objective, detailed scientific0 Q; f, b( f+ m# H$ }8 u% v& I
manner, with ample references to relevant guidances and the scientific literature. 7 w2 O, h# g4 ?) a, e, T" z8 OCompiling a book to be used as a scientific reference for the topic of& w, ~# G7 L! H/ S- B/ Y
pharmaceutical stress testing was a daunting task. Stress testing, as it relates - ?6 E. u& c5 z6 T. hto traditional small molecule pharmaceuticals, is very broad and scientifically3 R& N' B8 _. l; N% ?( G' `! i
complex. Thus, this book seeks to be a practical and scientific guide 7 q0 T1 ]- M4 g5 l3 `which will, hopefully, stimulate new ideas and further development of the 0 O, m/ i- U6 W% [1 }* kscience.1 S p W) k8 V- D6 V
This undertaking is done with some trepidation, since I realize that discussion" [: l- v1 D3 r1 C
of this topic could lead to attempts to formalize or standardize (i.e., ' h2 w+ z+ U1 J% J! O2 P% Mregulatory standardization) an area of pharmaceutical science that relies on + d* D0 f0 y) v5 F3 j% l1 vscientific expertise and flexibility. Each new drug compound, formulation, ^, G% L- A) [route of administration, delivery device, etc. has the potential to present4 j1 q6 f; v, [
unique challenges and unanticipated problems, and should be approached $ y/ l, I6 z- j5 N7 ~with such a mindset. The pharmaceutical researcher must be free to design& p. g1 d5 I3 {8 `! D$ `
and develop new ways to predict and measure stability-related issues 1 L' B$ {3 w) V! cthrough stress testing. Nonetheless, it is hoped that this book will provide5 b- E) c! j2 M' _; B8 }3 U
a useful and practical scientific guide that is a welcome addition to the ) @) P9 G. _6 g; K6 g. K' U! dlibrary of many pharmaceutical scientists. I am confident that the ‘‘artful+ w! K8 x5 O! V* f" E
science’’ of stress testing will evolve beyond what is represented in this book 6 n0 A. `# Q2 H' i2 M& Pas other scientists further the science and fill in topics that are poorly covered' l- q, D# Q! Y5 D7 Z
or missing.( b7 i3 K, P- x; o9 K3 i }
