Comparator drugs for clinical trials

Pharmaceutical Engineering

Volumn 17, Issue 2, 1997, Pages 48-56

  Carney, Charles F ^{a,b,c,d,e,f,g,h,i}   Killeen, Michael J ^j,k,l,m,n,o   Schulteis, William M ^p,q,r  

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^b UNIVERSITY OF ROCHESTER   (United States)

^c STATE UNIVERSITY OF NEW YORK   (United States)

^d UNIVERSITY OF CONNECTICUT   (United States)

^e Ayerst Laboratories   (United States)

^f BIPI   (United States)

^g BI Corporation   (United States)

^h PMA   (United States)

ⁱ ISPE   (United States)

^j Clin Devmt and Mfg Department   (United States)

^k Morris Plains Facility ^*  (United States)

^l Warner Lambert Co   (United States)

^m PRATT INSTITUTE   (United States)

ⁿ Arnold Marie Schwartz Coll P   (United States)

^o PFIZER INC   (United States)

^p SANOFI   (France)

^q UNIVERSITY OF KANSAS   (United States)

^r University of Kansas ^*

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; DRUG DEVELOPMENT;

EID: 0030994295     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. Code of Federal Regulations, 21CFR314.126
2. European Commission Directorate-General III Industry : Annex III/3004/91-EN
3. European Commission Directorate-General III Industry : Annex III/3830/92-EN
4. USP DI Vol III, Approved Drug Products and Legal Requirements.
5. Checklist for Supplying Comparator Drug, published by Pharmaceutical Manufacturers of America (April 1991)
6. Agreement Regarding the Provision and Transfer of Control Drugs, Japan Pharmaceutical Industries Association (June 1991)
7. Federal Register, Vol. 58 No.175 September 13, 1993, pp 47948
8. Code of Federal Regulations, 21CFR 206.7
9. Code of Federal Regulations, 21CFR 312.110
10. Federal Register, Congressional Record April 25, 1996, pp H3925-H3934
11. Code of Federal Regulations, 21CFR 312.120