SCOPUS 정보 검색 플랫폼

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 51, Issue 1, 2001, Pages 1-7

Biopharmaceuticals approved in the EU 1995-1999: A European Union-United States comparison

(2) Reichert, Janice M a Healy, Elaine M a

Author keywords

Biopharmaceutical; Centralized procedure; Drug development; European Medicines Evaluation Agency; Food and Drug Administration

Indexed keywords

ANTISENSE OLIGONUCLEOTIDE; BECAPLERMIN; BETA1A INTERFERON; CONSENSUS INTERFERON; DESULFATOHIRUDIN; FOMIVIRSEN; IMIGLUCERASE; INFLIXIMAB; INSULIN ASPART; INSULIN LISPRO; INTERFERON BETA SERINE; INTERLEUKIN 2 RECEPTOR ANTIBODY; LEPIRUDIN; PALIVIZUMAB; RECOMBINANT BLOOD CLOTTING FACTOR 7A; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT FOLLITROPIN; RECOMBINANT HUMAN INSULIN; RECOMBINANT PROTEIN; RETEPLASE; SALCATONIN; TASONERMIN; UNCLASSIFIED DRUG;

ARTICLE; DATA BASE; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG MARKETING; EUROPE; FOOD AND DRUG ADMINISTRATION; RECOMBINANT DNA TECHNOLOGY; UNITED STATES;

BIOPHARMACEUTICS; DRUG APPROVAL; EUROPEAN UNION; FORMULARIES; UNITED STATES;

EID: 0035168430 PISSN: 09396411 EISSN: None Source Type: Journal
DOI: 10.1016/S0939-6411(00)00131-4 Document Type: Article

Times cited : (12)

References (13)

1
- 0032740491
- The European Agency for the evaluation of medicinal products' centralized procedure for product approval: Current status
- (1999) Drug Inf. J. , vol.33 , Issue.4 , pp. 969-978
- Healy, E.M.¹ Kaitin, K.I.²

2
- 0028094443
- European Community harmonization of the licensing and manufacturing of medicinal products
- (1994) Food Drug Law J. , vol.49 , Issue.1 , pp. 141-170
- Friedel, E.¹ Freundlich, M.²

3
- 85002299933
- Council Directive 87/22, 1987 O.J. (L 15) 38

4
- 85002299925
- Prescription Drug User Fee Act of 1992. US Public Law 102-571 (1992 Oct 29); 21 USC 379; 106 Stat 4491

5
- 85001928877
- Food and Drug Administration Modernization Act of 1997. US Public Law 105-115 (1997 Nov 21); 21 USC 355a; 111 Stat 2296

6
- 0034283885
- New biopharmaceuticals in the USA: Trends in development and marketing approvals 1995-1999
- (2000) Trends Biotechnol. , vol.18 , Issue.9 , pp. 364-369
- Reichert, J.M.¹

7
- 85002237634
- The effects of PDUFA and FDAMA on the development and approval of therapeutic medicines
- in press
- (2000) Drug Inf. J.
- Reichert, J.M.¹ Chee, J.² Kotzampaltiris, C.S.³

8
- 85002344514
- Fourth annual performance report: Prescription Drug User Fee Act of 1992. Fiscal Year 1996 Performance Report to Congress. US Food and Drug Administration, Rockville, MD, December 1996

9
- 85002444628
- Final performance report: Prescription Drug User Fee Act of 1992. Fiscal Year 1997 Report to Congress. Food and Drug Administration, Rockville, MD, December 1997

10
- 85002227697
- Fiscal Year 1998 performance report to Congress for thePrescription Drug User Fee Act of 1992 as amended by the Food and Drug Administration Modernization Act of 1997. http://www.fda.gov/ope/opehome.html

11
- 85001965479
- Fiscal Year 1999 performance report to Congress for the Prescription Drug User Fee Act of 1992 as reauthorized and amended by theFood and Drug Administration Modernization Act of 1997. http://www.fda.gov/ope/opehome.html

12
- 85001965476
- CPMP/495/96 http://www.eudra.org

13
- 85001903241
- Temodal European public assessment report http://www.eudra.org

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.