TY - JOUR
T1 - Toward a generic approach for
T2 - Stress testing of drug substances and drug products
AU - Klick, Silke
AU - Muijselaar, Pim G.
AU - Waterval, Joop
AU - Eichinger, Thomas
AU - Korn, Christian
AU - Gerding, Thijs K.
AU - Debets, Alexander J.
AU - Sänger-Van De Griend, Cari
AU - Van Den Beld, Cas
AU - Somsen, Govert W.
AU - De Jong, Gerhardus J.
PY - 2005/2
Y1 - 2005/2
N2 - The Impurity Profiling Group has developed a generic approach for conducting stress testing on drug substances and drug products. The proposed strategy is evaluated and verified with historical data and new experiments. Results demonstrate that the proposed approach is reasonable and generates relevant, generally predictive results for the development of a stability-indicating method.
AB - The Impurity Profiling Group has developed a generic approach for conducting stress testing on drug substances and drug products. The proposed strategy is evaluated and verified with historical data and new experiments. Results demonstrate that the proposed approach is reasonable and generates relevant, generally predictive results for the development of a stability-indicating method.
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M3 - Review article
AN - SCOPUS:13444273611
SN - 1543-2521
VL - 29
SP - 48
EP - 66
JO - Pharmaceutical Technology
JF - Pharmaceutical Technology
IS - 2
ER -