SCOPUS 정보 검색 플랫폼

Journal of Pharmaceutical and Biomedical Analysis

Volumn 24, Issue 5-6, 2001, Pages 755-767

Validation in pharmaceutical analysis. Part I: An integrated approach

(1) Ermer, Joachim a

a SANOFI AVENTIS DEUTSCHLAND GMBH (Germany)

Author keywords

Acceptance limits; Pharmaceutical analysis; Quality assurance; Specification limits; Validation

Indexed keywords

ACCURACY; ANALYTIC METHOD; CONFERENCE PAPER; DRUG IMPURITY; DRUG INDUSTRY; DRUG STABILITY; EVALUATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; REPRODUCIBILITY; VALIDATION PROCESS;

CHEMISTRY, PHARMACEUTICAL; EVALUATION STUDIES; GUIDELINES; QUALITY CONTROL; SENSITIVITY AND SPECIFICITY;

EID: 0035097208 PISSN: 07317085 EISSN: None Source Type: Journal
DOI: 10.1016/S0731-7085(00)00530-6 Document Type: Conference Paper

Times cited : (249)

References (29)

1
- 85030209302
- Febr.
- (1988) Erläuterungen des BGA zum Antrag auf Zulassung eines Arzneimittels

2
- 0005684377
- Addendum
- (1990) The Rules Governing Medicinal Products in the European Community , vol.3

3
- 0005661410
- U.S. Food and Drug Administration, Center for Drugs and Biologics, Department of Health and Human Services
- (1994) CDER Guideline on Validation of Chromatographic Methods, Reviewer Guidance of Chromatographic Methods

4
- 0003637741
- U.S. Food and Drug Administration, Center for Drugs and Biologics, Department of Health and Human Services
- (1987) Guidelines for Submitting Samples and Analytical Data for Methods Validation

5
- 0005753819
- Section 〈1225〉, United States Pharmacopeial Convention, Rockville
- (1995) Validation of Compendial Methods

6
- 0005731989
- National Health and Welfare, Health Protection Branch, Health and Welfare Canada
- (1992) 'Acceptable Methods', Drug Directorate Guidelines

8
- 0003663994
- November
- (1996) ICH: Q2B Analytical Validation-Methodology

9
- 0005660924
- March, revised October 1999, Step 2
- (1995) ICH: Q3A, Impurities in New Drug Substances

10
- 0005757053
- November, revised October 1999, Step 2
- (1996) ICH: Q3B, Impurities in New Drug Products

11
- 0005751611
- July
- (1997) ICH: Q3C, Residual Solvents

12
- 0005662134
- ICH: Q6A, Specifications: Test procedures and acceptance criteria for new drug substances and new drug products
- October
- (1999) Chemical Substances

13
- 0003582181
- March
- (1999) ICH: Q6B, Specifications: test procedures and acceptance criteria for biotechnological/biological products

14
- 0004137386
- Febr.
- (1998) LC-GC International , pp. 96-105
- Huber, L.¹

15
- 0008296790
- (1997) Pharmeuropa 9.1 , pp. 148-156
- Daas, A.G.J.¹ Miller, J.H.Mc.B.²

16
- 0005763349
- (1997) Pharmeuropa 9.1 , pp. 139-143
- Van de Vaart, F.J.¹

17
- 4243907223
- 29-30 Nov., London
- (1999) Analytical validation: formal requirements and practical approaches, solution for scientists symposium
- Renger, B.¹

18
- 45449119706
- US Food and Drug Administration, Center for Drug Evaluation and Research (CDER)
- (1998) Draft guidance for industry on investigating out of specification (OOS) test results in pharmaceutical production

19
- 0005745480
- (1998) Pharmacopeial Forum , vol.24 , pp. 7051-7056
- Whitfield, R.G.¹ Hughes, D.W.² Layloff, T.P.³ Cox, R.R.⁴ Gressett, G.E.⁵ Jimenez, P.J.⁶ Andersen, J.⁷ Reck, R.R.⁸ Schniepp, S.⁹

20
- 0005667622
- LC-GC International, March
- (1998) , pp. 160-164
- Persson, B.-A.¹ Vessman, J.² McDowall, R.D.³

21
- 33845216655
- Statistical parameters and analytical figures of merit
- C.M. Riley, T.W. Rosanske (Eds.), Elsevier, Oxford
- (1996) Development and Validation of Analytical Methods , pp. 15
- Riley, C.M.¹

22
- 0028878470
- (1995) Chromatographia , vol.40 , pp. 15-22
- Meyer, V.R.¹

23
- 0026665284
- (1992) S.T.P. Pharma Pratiques , vol.2 , Issue.4 , pp. 205-226
- Caporal-Gautier, J.¹ Nivet, J.M.² Algranti, P.³ Guilloteau, M.⁴ Histe, M.⁵ Lallier, M.⁶ N'Guyen-Huu, J.J.⁷ Russotto, R.⁸

24
- 0038748909
- Draft Guidance (Food and Drug Administration), August
- (2000) Guidance for industry: analytical procedures and methods validation, chemistry, manufacturing, and controls documentation

26
- 0005667623
- NOVIA GmbH, Saarbrücken, Germany
- MVA-Method validation in analytics (PC-software, Windows NT)

27
- 0003854902
- Verlag Chemie, Weinheim
- (1985) Statistische Methoden in der Wasseranalytik
- Funk, W.¹ Dammann, V.² Vonderheid, C.³ Oehlmann, G.⁴

28
- 0005660927
- Begriff, Verfahren, Auswertung. Beuth Verlag GmbH, Berlin
- DIN 32 645: Chemische Analytik: Nachweis-, Erfassungs- und Bestimmungsgrenze, Ermittlung unter Wiederholbedingungen

29
- 0005696306
- EURACHEM Guidance Document No. WDG 2: Accreditation for chemical laboratories: Guidance on the interpretation of the EN 45000 series of standards and ISO/IEC Guide 25
- (1993)

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.