SCOPUS 정보 검색 플랫폼

Quality Assurance Journal

Volumn 6, Issue 3, 2002, Pages 143-157

A qualitative examination of FDA warning letters - What can we learn from GCP inspections?

(1) Wilsher, Colin R a,b,c

a PFIZER GLOBAL RESEARCH AND DEVELOPMENT (United Kingdom)

b BANGOR UNIVERSITY (United Kingdom)

c NONE (United Kingdom)

Author keywords

FDA; GCP; Inspection; Warning letters

Indexed keywords

ARTICLE; DOCUMENTATION; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; LICENSING; PRIORITY JOURNAL; QUALITY CONTROL; VALIDATION PROCESS;

EID: 0036723313 PISSN: 10878378 EISSN: None Source Type: Journal
DOI: 10.1002/qaj.186 Document Type: Article

Times cited : (1)

References (6)

1
- 0010052127
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of European Communities. 2001; 121:43-44

2
- 0010057804
- FDA audits of clinical studies
- (1992) Appl Clin Trials , vol.1 , Issue.5 , pp. 24-30
- Horowitz, A.M.¹

3
- 0010054253
- QUASAR
- (2000) J Br Assoc Res Qual Assur , vol.72 , pp. 28-29
- Wilsher, C.R.¹

4
- 0010057806
- FDA regulatory inspections in the UK
- (2001) CRFocus , vol.12 , Issue.1 , pp. 45-46
- Hepworth-Jones, B.¹

5
- 0009984087
- CPMP/ICH/135/95
- (1996) International Conference Harmonisation Harmonised Tripartite Guidelines for Good Clinical Practice

6
- 0009980610
- The facts about source documents
- 29 June
- (1999) DIA Annual Meeting
- Woollen, S.W.¹

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.