Transfer of analytical methods: Metholodogy;Transfert des méthodes analytiques: Méthodologie

S.T.P. Pharma Pratiques

Volumn 12, Issue 6, 2002, Pages 337-343

  Minois Offroy, F ^g   Appriou, Y ^a   Brousset, V ^b   Chapuzet, E ^c   De Fontenay, G ^b   Dewe, W ^d   Dumas, E ^e   Ellie, C ^f   Galiay, M ^g   Lefebvre, N ^g   Mottu, P ^h   Quint, M P ⁱ   Schoeffter, F ^g  

^a Orgamol France SA   (France)

^b Allergan R and D Europe ^*  (France)

^c Qualilab   (France)

^d Eli Lilly Benelux   (Belgium)

^e PFIZER INC   (United States)

^f INSTITUT DE RECHERCHE PIERRE FABRE   (France)

^g SANOFI   (France)

^h Isochem   (France)

ⁱ MSD Chibret   (France)

Author keywords

Analytical transfer; Equivalence of results; Qualification of a laboratory

Indexed keywords

ANALYTIC METHOD; ARTICLE; BIOTECHNOLOGY; LABORATORY; PRACTICE GUIDELINE; STATISTICAL ANALYSIS;

EID: 17744402127     PISSN: 11571497     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. MENT W.-Technology transfer of analytical methods - FDA News and information, vol 2, N°3, 1-3, 17 Août 2001
2. PISARIK L., BLAIS P.Y., CARRAUD P., DOUERE F., FROISSANT A., KOEBERLE-RAMOND S., LAUGEL V., MUFFAT F., AND PROTHEAU-CHABRAT V.-Les transferts de production. - STP Pharma Prat., 10 (2) 61-74, 2000.
3. Guide technique pour l'élaboration des monographies. 3ème édition - Pharmeuropa, special issue dec. 1999.
4. Norme NF ISO 5725-1 à 6 -Recueil Afnor - Normes et règlements Essais et analyses - Maîtriser la conception et la réalisation - Volume 1: expression du besoin et conception
5. 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 Journal, vol 35, p1271-p1288 - 2001.
6. Technology transfer guideline: draft - ISPE Technical guideline - January 2002.
7. SCHUIRMANN D.J. - PHARMACOMETRICS. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavaiability - Journal of Pharmacokinetics and Biopharmaceutics, vol 15, N°6, 657-680, 1987.