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Stress testing is the main tool that is used to predict stability problems,; [7 _; v0 f6 F5 t1 F5 d
develop analytical methods, and identify degradation products/pathways.
/ r8 w9 S* F4 m! R2 i3 a" {Since there are no detailed regulatory guidelines that direct how stress testing
+ C( S: c4 H6 `" a% {is to be done, nor has there ever been a text/reference book on the
2 O3 e- ?+ n3 a3 tsubject, stress testing has evolved into an artful science that is highly dependent0 c* Z5 i' j- n. A" U8 U( v5 g# s( t
on the experience of the company or the individuals directing the studies. This
4 h7 Q! Z+ g; Y+ r; Xbook provides readers with a single source reference that benchmarks the2 Q( P( |: i- [- m1 \" ^
current best practices of experienced pharmaceutical scientists/researchers.
* G+ X2 v0 ~7 a# Q& eQuestions like ‘‘How hot, how long, what conditions are appropriate?’’ and
3 J1 h& B( K* n6 r# ? K( Qtopics such as mass balance, photostability, oxidative susceptibility, and the
4 ?1 V( E* L8 e4 d' rchemistry of drug degradation are addressed in an objective, detailed scientific: |4 V; x2 G9 M) U* Z& H
manner, with ample references to relevant guidances and the scientific literature.2 M+ \; I' H' V6 Q
Compiling a book to be used as a scientific reference for the topic of
+ H2 n- [" }! upharmaceutical stress testing was a daunting task. Stress testing, as it relates
" _/ [4 C) j: |4 z% ^3 J/ Z+ l5 |to traditional small molecule pharmaceuticals, is very broad and scientifically$ p. \- F, ^/ F! }* |9 N8 x
complex. Thus, this book seeks to be a practical and scientific guide
) Z! R6 q l, M" p5 ywhich will, hopefully, stimulate new ideas and further development of the
7 x7 c. ]2 a: J1 T& Pscience.) C7 z8 T4 S/ `; S# Q% K) M# Z
This undertaking is done with some trepidation, since I realize that discussion
- L2 H0 A* Z1 `0 X5 V0 R8 Vof this topic could lead to attempts to formalize or standardize (i.e.,4 c' {: b% e1 g: J) {
regulatory standardization) an area of pharmaceutical science that relies on
\- i7 M \/ K* l) ~( Oscientific expertise and flexibility. Each new drug compound, formulation,& E0 ~/ A# J, U$ j2 {! o1 C! I& L
route of administration, delivery device, etc. has the potential to present! s5 k( ^$ r/ p! h
unique challenges and unanticipated problems, and should be approached
4 g. G" g, V, h% J* ?with such a mindset. The pharmaceutical researcher must be free to design5 }8 B- k5 B. T7 ?* c' f4 M. M: L
and develop new ways to predict and measure stability-related issues
3 q! |& j% v" r$ b: b# j6 Othrough stress testing. Nonetheless, it is hoped that this book will provide" g7 I! I9 M' s1 {) g
a useful and practical scientific guide that is a welcome addition to the( u% \6 n* s, [
library of many pharmaceutical scientists. I am confident that the ‘‘artful; L; w2 r8 [; _
science’’ of stress testing will evolve beyond what is represented in this book: {' n4 F) q% l2 a7 ]2 u
as other scientists further the science and fill in topics that are poorly covered u' Q/ [$ m" _6 I5 o0 x
or missing.
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