Analytical transfers and testing;Transferts analytiques et contrôles

S.T.P. Pharma Pratiques

Volumn 12, Issue 5, 2002, Pages 258-259

  Galiay, Michel ^a  

^a SANOFI   (France)

Author keywords

Acceptance criteria; Analytical transfers; Qualification; Testing

Indexed keywords

NEW DRUG;

ANALYTIC METHOD; CONFERENCE PAPER; DRUG DETERMINATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG RESEARCH; LABORATORY; QUALITY CONTROL; SOCIOECONOMICS; VALIDATION PROCESS;

EID: 0036770698     PISSN: 11571497     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (6)

1. ISPE Guideline. - Analytical procedure/Technology transfer.
2. KRINGLER R., KHAN-MALEK R., SNIKERIS F., MUNDEN P., AGUT C., BAUER M. - A unified approach for design and analysis of transfer studies for analytical methods - Drug Information J., 35, 1271-1288, 2001.
3. MINOIS-OFFROY F. et al. - Rapport de commission SFSTP « Transferts analytiques ». - STP Pharma Prat., à paraître.
4. PISARIK L. et al. - Les transferts de production. - STP Pharma Prat., 10 (2), 61-74, 2000.
5. SCHUIRMANN D.J. - A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. - J. Pharmacokin. Biopharm., 15, 6 657-680, 1987.
6. VIAL J., JARDY A., ANGER P., BRUN A., MENET J.M. - Methodology for transfer of liquid chromatography methods based on statistical considerations. - J. Chromatogr. A. 815, 173-182, 1998.