Toward a generic approach for: Stress testing of drug substances and drug products

Silke Klick; Pim G. Muijselaar; Joop Waterval; Thomas Eichinger; Christian Korn; Thijs K. Gerding; Alexander J. Debets; Cari Sänger-Van De Griend; Cas Van Den Beld; Govert W. Somsen; Gerhardus J. De Jong

Toward a generic approach for: Stress testing of drug substances and drug products

Silke Klick^*
, Pim G. Muijselaar
, Joop Waterval
, Thomas Eichinger
, Christian Korn
, Thijs K. Gerding
, Alexander J. Debets
, Cari Sänger-Van De Griend
, Cas Van Den Beld
, Govert W. Somsen
, Gerhardus J. De Jong

^*Corresponding author for this work

AIMMS

Research output: Contribution to Journal › Review article › Academic › peer-review

Abstract

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.

Original language	English
Pages (from-to)	48-66
Number of pages	19
Journal	Pharmaceutical Technology
Volume	29
Issue number	2
Publication status	Published - Feb 2005

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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title = "Toward a generic approach for: Stress testing of drug substances and drug products",

abstract = "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.",

author = "Silke Klick and Muijselaar, \{Pim G.\} and Joop Waterval and Thomas Eichinger and Christian Korn and Gerding, \{Thijs K.\} and Debets, \{Alexander J.\} and \{S{\"a}nger-Van De Griend\}, Cari and \{Van Den Beld\}, Cas and Somsen, \{Govert W.\} and \{De Jong\}, \{Gerhardus J.\}",

year = "2005",

month = feb,

language = "English",

volume = "29",

pages = "48--66",

journal = "Pharmaceutical Technology",

issn = "1543-2521",

publisher = "Advanstar Communications Inc.",

number = "2",

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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.

UR - https://www.scopus.com/pages/publications/13444273611

UR - https://www.scopus.com/pages/publications/13444273611#tab=citedBy

M3 - Review article

AN - SCOPUS:13444273611

SN - 1543-2521

VL - 29

SP - 48

EP - 66

JO - Pharmaceutical Technology

JF - Pharmaceutical Technology

IS - 2

ER -

Toward a generic approach for: Stress testing of drug substances and drug products

Abstract

UN SDGs

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