Transfer of Analytical Procedures

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Volumn , Issue , 2005, Pages 281-300

  Broughton, Mark ^a   Ermer, Joachim ^b  

^a Aventis Pharma Resp Technology   (United Kingdom)

^b SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

Author keywords

Comparative studies; Dissolution; Method validation; Pharmaceutical analysis; Process description; Transfer of analytical procedures; Transfer process

Indexed keywords

EID: 84882971306     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/3527604685.ch7     Document Type: Chapter

References (10)

1. ISPE: Good Practice Guide: Technology Transfer (2003) (www.ispe.org).
2. J. Vial, A. Jardy, P. Anger, A. Brun, J.-M. Menet: Methodology for transfer of LC methods based on statistical considerations. J. Chromatogr. A 815 (1998) 173-182.
3. R. Kringle, R. Khan-Malek, F. Snikeris, P. Munden, C. Agut, M. Bauer: A unified approach for design and analysis of transfer studies for analytical methods. Drug Information J. 35 (2001) 1271-1288.
4. A. Brutsche: Transfer of analytical methods (Novartis). IAPT-Course 227: Transfer of analytical methods, Feb. 17-18 2004, Darmstadt (www.apv-mainz.de).
5. L. Peeters: Transfer of analytical methods (Johnson & Johnson) IIR Lifesciences Course: Analytical Method Validation, Oct. 20-22 2003, London.
6. M. Fischer: Transfer of analytical procedures (Lilly). European Compliance Academy Course: FDA-Compliance in Analytical Laboratories, April 28-30 2004, (www.concept-heidelberg.de).
7. USP: <1010> Analytical Data-Interpretation and Treatment. Pharmacopeial Forum 30 (2004) 236-263.
8. G. Limentani, M. Ringo, M. Bergquist, F. Ye, E. McSorley: A pragmatic approach to the design of scientifically rigorous method transfer and method equivalence studies using a statistical equivalence test. Proceedings of the Pharmaceutical and Biomedical Analysis Conference, Florence 2004, 14.
9. FDA: Dissolution testing of immediate release solid oral dosage forms (Guidance for Industry) 2001.
10. J.B. Crowther, M.I. Jimidar, N. Niemeijer, P. Salomons: Qualification of laboratory instrumentation, validation, and transfer of analytical methods. In: Analytical Chemistry in a GMP Environment. A Practical Guide. Eds. J.M. Miller and J.B. Crowther, Wiley, New York 2000, 423-458.