Bioanalytical method validation: A quality assurance auditor view point

Journal of Pharmaceutical Sciences and Research

Volumn 1, Issue 3, 2009, Pages 1-10

  Kalakuntla, Rama Rao ^a   Kumar, K Santosh ^b  

^a Apotex Pharmachem India Pvt Ltd   (India)

^b RANBAXY RESEARCH LABORATORIES   (India)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANTICOAGULATION; BIOANALYTICAL METHOD VALIDATION; BODY FLUID; CALIBRATION; CHROMATOGRAPHY; DILUTION; DRUG STABILITY; EXTRACTION; QUALITY CONTROL; REVIEW; SENSITIVITY ANALYSIS; STANDARD;

EID: 77953399225     PISSN: None     EISSN: 09751459     Source Type: Journal    
DOI: None     Document Type: Review

References (5)

1. Vinod P Shah. The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation. The AAPS Journal 2007; 9(1) Article 5.
2. Organization for economic co-operation and development. OECD series on principles of Good Laboratory Practice and compliance monitoring number 4 (revised). GLP consensus document: Quality Assurance and GLP environment directorate. Organization for economic co-operation and development, Paris 1999.
3. Food and Drug Administration. Guidance for industry; Bionalytical Method Validation, Center for Drug Evaluation and Research, May 2001.
4. Surendra Bansal and Anthony Destefano. Key elements of bioanalytical method validation for small molecules. The AAPS Journal 2007; 9(1) Article 11.
5. William Nowatzke and Eric Woolf. Best practices during bionalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls and study samples. The AAPS Journal 2007; 9(2) Article 13.