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

ADVERTISEMENT

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 Draft Guidance for Industry.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.


blog comments powered by Disqus

ADVERTISEMENT

Moscow Hosts IFPMA Biosimilars Conference
May 17, 2013
AbbVie and Alvine Will Collaborate on Celiac Disease Therapy
May 15, 2013
FDA Issues Pharmacoepidemiologic Safety Study Guidance
May 14, 2013
USP Launches Initiative to Fight Counterfeit Drugs in Sub-Saharan Africa
May 13, 2013
Amgen Forms New Joint Venture to Commercialize Vectibix in China
May 13, 2013
Upcoming Conferences
UPCOMING CONFERENCES

Access Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA | July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA | August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA | August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA | August 20-21, 2013
Request Brochure

See All Conferences >>

ADVERTISEMENT

Author Guidelines
FindPharma
Source: BioPharm International,
Click here