Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry

Journal of Pharmaceutical and Biomedical Analysis

Volumn 126, Issue , 2016, Pages 83-97

  Kadian, Naveen ^a   Raju, Kanumuri Siva Rama ^a,b   Rashid, Mamunur ^a   Malik, Mohd Yaseen ^a   Taneja, Isha ^a,b   Wahajuddin, Muhammad ^a,b  

^a CENTRAL DRUG RESEARCH INSTITUTE   (India)

^b Academy of Scientific and Innovative Research   (India)

Author keywords

ANVISA; Bioanalysis; EMA; MHLW; Regulatory guidance; USFDA; Validation

Indexed keywords

ARTICLE; COMPARATIVE STUDY; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HUMAN; LIMIT OF DETECTION; LIMIT OF QUANTITATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RECEPTOR BINDING ASSAY; STANDARD; CHEMICAL ANALYSIS; INTERNATIONAL COOPERATION; PROCEDURES; STANDARDS; VALIDATION STUDY;

DRUG;

CHEMISTRY TECHNIQUES, ANALYTICAL; DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; INTERNATIONALITY; PHARMACEUTICAL PREPARATIONS; VALIDATION STUDIES AS TOPIC;

EID: 84965125884     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2016.03.052     Document Type: Article

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