Metrologic approaches to setting acceptance criteria: Unacceptable and unusual characteristics-Reference-Cited by-同舟云学术

Metrologic approaches to setting acceptance criteria: Unacceptable and unusual characteristics

Published:2008-11 Issue:3 Volume:48 Page:1042-1045
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Hauck Walter W.,Abernethy Darrell R.,Williams Roger L.

Publisher

Elsevier BV

Subject

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

Reference9 articles.

1. FDA, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations, 2002, accessed at www.fda.gov/cder/guidance/4964dft.pdf (accessed 29 August 2008).

2. Introduction to Statistical Quality Control;Montgomery,2001

3. Statistical Intervals, A Guide for Practitioners;Hahn,1991

4. US Pharmacopeia, USP 31–NF 26, The Dissolution Procedure: Development and Validation, US Pharmacopeia, Rockville, MD, 2008.

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