Precision of the reportable value—Statistical optimization of the number of replicates

Author:

Burdick Richard K.,Ermer Joachim

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference18 articles.

1. Stimuli to the revision process: analytical target profile;Barnett;Struct. Appl. Throughout Anal. Lifecycle, Pharmacopoeial Forum,2016

2. Stimuli to the Revision Process: Proposed New USP General Chapter: The Analytical Procedure Lifecycle ⟨1220⟩;Martin;Pharm. Forum,2017

3. International Council on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH),2005

4. Method Validation in Pharmaceutical Analysis. A Guide to Best Practice,2015

5. Stimuli to the Revision Process: Analytical Control Strategy;Kovacs;Pharmacopoeial Forum,2016

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