Analytical Method Development and Optimization - Validation of analytical methods can be more easily accomplished by breaking the task down into a series of planned steps. - BioPharm International

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Analytical Method Development and Optimization
Validation of analytical methods can be more easily accomplished by breaking the task down into a series of planned steps.


BioPharm International


References

1. International Conference on Harmonization (ICH). Q2(R1), Validation of analytical procedures. Current Step 4 Version. Geneva, Switzerland; 2005.

2. Eurachem Guide. Fitness for Purpose of Analytical Methods. Teddington, UK; 1998.

3. Center for Drug Evaluation and Research. Guidance for Industry. Bioanalytical Method Validation. Bethesda MD; 2001.

4. Center for Biologics Evaluation and Research. Draft Guidance for Industry. Analytical procedures and methods validation. Bethesda, MD; 2000.

5. Muire-Sluis A. Presented at Biological Assay Development and Validation; 2004 Apr 26–28; San Diego, CA.

6. United States Pharmacopoeia. USP 30 <1225>. Validation of Compendial Methods. 2007.

7. Pharmacopoeial Forum 32 <1226> Verification of Comendial Test Procedures. PF, Vol 32 (4), July August 2006.

8. Schenerman MA, et al. CMC strategy forum report: analysis and structure characterization of monoclonal antibodies. BioProcess Int 2004;(2):42–53.

9. Lucy PK, Beri RG. Key considerations in process transfer. BioProcess International 2003;(8):36–43.

10. Nguyen LT, et al. Characterization methods for the physical stability of biopharmaceuticals. PDA J Pharm Sci Technol. 2003;57(6):429–45.

11. ICH. Q6B, Specifications: test procedures and acceptance criteria for biotechnological/biological products. ICH Harmonized Tripartite Guideline. Geneva, Switzerland; 1999.

12. ICH. Q7A, Good manufacturing practice guide for active pharmaceutical ingredients. Draft Consensus Guideline. Geneva, Switzerland; 2000.

13. Capen R. Revising USP <111> Design and analysis of bio-assays: current status and future plans. Presented at Biological Assay Development and Validation; 2004 Apr 26–28; San Diego, CA.

14. Callahan J. New USP guidelines for parallelism. Presented at Biological Assay Development and Validation; 2004 Apr 26–28; San Diego, CA.

15. American Society for Testing and Materials (ASTM). ASTM E 1488-02, Standard guide for statistical procedures to use in developing and applying test methods. West Conshohocken, PA; 2002.

16. ASTM. ASTM E 1169-02, Standard guide for conducting ruggedness tests. West Conshohocken, PA; 2002.

17. ASTM. ASTM D 4853-97, Standard guide for reducing test variability. West Conshohocken, PA; 1997.

18. ASTM. ASTM D 4854-95, Standard guide for estimating the magnitude of variability from expected sources in sampling plans. West Conshohocken, PA; 1995.

19. ASTM. ASTM D 4855–97, Standard practice for comparing test methods. West Conshohocken, PA: ASTM; 1997.

20. Krause, SO, Validation of Analytical Methods for Biopharmaceuticals—A guide to risk-based validation and implementation strategies. PDA/DHI Publishing. Bethesda, MD; 2007 Apr.


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