Implications of differences in bioanalytical regulations between Canada, USA and South America

Bioanalysis

Volumn 3, Issue 3, 2011, Pages 253-258

  Arnold, Mark E ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG;

ANALYTIC METHOD; BIOEQUIVALENCE; CANADA; CERTIFICATION; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG QUALITY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; GOVERNMENT REGULATION; HEALTH CARE ORGANIZATION; REGISTRATION; REVIEW; SOUTH AMERICA; UNITED STATES;

BRAZIL; CANADA; DRUG INDUSTRY; HUMANS; INTERNATIONAL COOPERATION; PHARMACEUTICAL PREPARATIONS; SOUTH AMERICA; UNITED STATES;

EID: 79951763925     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.187     Document Type: Review

References (14)

1. Kaitin K. The landscape for pharmaceutical innovation: drivers of cost-effective clinical research. Pharmaceutical Outsourcing 11(3), 28,30,32 (2010).
2. Hughes B. Evolving R&D for emerging markets. Nat. Rev. Drug Discov. 9(7), 417 (2010).
3. Timmerman P, Lowes S, Fast DM, Garofolo F. Request for global harmonization of the guidance for bioanalytical method validation and sample analysis. Bioanalysis 2(4), 683 (2010). 4 Bansal S, Arnold M, Garofolo F. International harmonization of bioanalytical guidance. Bioanalysis 2(4), 685-687 (2010).
4. van Amsterdam P, Lausecker B, Luedtke S, Timmerman P, Brudny-Kloeppel M. Towards harmonized regulations for bioanalysis: moving forward! Bioanalysis 2(4), 689-691 (2010).
5. Savoie N, Garofolo F, van Amsterdam P et al. 2010 white paper on recent issues in regulated bioanalysis and global harmonization of bioanalytical guidance. Bioanalysis 2(12), 1945-1960 (2010).
6. van Amsterdam P, Arnold M, Bansal S et al. Building the global bioanalysis consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation. Bioanalysis 2(11), 1801-1803 (2010).
7. Guidance for industry: conduct and analysis of bioavailability and bioequivalence studies - part A: oral dosage formulations used for systemic effects. Health Canada (1992).
8. US FDA, Centre for Drug Evaluation and Research, Centre for Veterinary Medicine. Guidance for Industry: Bioanalytical Method Validation. (2001).
9. Notice to industry: removal of requirement for 15% random replicate samples. Health Canada (2003).
10. Viswanathan CT, Bansal S, Booth B et al. Bioanalytical method validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9(1), E30-E38 (2007).
11. Fast D, Kelley M, Viswanathan C et al. Workshop report and follow-up - AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples - implications of crystal city recommendations. AAPS J. 11(2), 238-241 (2009).
12. Guidelines for elaborating a relative bioavailability/bioequivalence study s technical report. Resolution 895. ANVISA, Brazil (2003).
13. Guide for validation of analytical and bioanalytical methods. Resolution 899. ANVISA, Brazil (2003).
14. Clarification Regarding the Application of RE No. 899/2003 - Validation of Bioanalytical Methods. ANVISA, Brazil (2008).