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Sample Preparation Method Validation

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Sample Preparation of Pharmaceutical Dosage Forms

Abstract

The analytical procedure describes all the steps and details associated with performing an analysis. The validation process establishes the performance characteristics of the analytical procedure to meet the output requirements for the intended analytical application. During most validation processes, little attention is spent on sample preparation conditions and their effect on the overall analytical method. Potential approaches and practices commonly used for the sample preparation component of the analytical procedure during the validation process are discussed.

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Author information

Authors and Affiliations

  1. Quality Laboratory Operations, Celgene Corporation, 86 Morris Avenue, Summit, NJ, 07901, USA

    Edmund J. Bishop Ph.D.

  2. Pharmaceutical and Analytical R&D, Hoffmann-La Roche Inc., Nutley, NJ, USA

    Dawen Kou Ph.D., Gerald Manius B.S. & Hitesh P. Chokshi Ph.D.

Authors
  1. Edmund J. Bishop Ph.D.
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  2. Dawen Kou Ph.D.
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  3. Gerald Manius B.S.
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  4. Hitesh P. Chokshi Ph.D.
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Corresponding author

Correspondence to Edmund J. Bishop Ph.D. .

Editor information

Editors and Affiliations

  1. Pfizer Global Research & Development, Analytical Research & Development Dept., Pfizer Inc., Eastern Point Road 4086, Groton, 06340, Connecticut, USA

    Beverly Nickerson

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Bishop, E.J., Kou, D., Manius, G., Chokshi, H.P. (2011). Sample Preparation Method Validation. In: Nickerson, B. (eds) Sample Preparation of Pharmaceutical Dosage Forms. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-9631-2_10

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