-
1
-
-
0003438209
-
Valid Analytical Methods and Procedures
-
ISBN 0-85404-482-5
-
C. Burgess: Valid Analytical Methods and Procedures. The Royal Society of Chemistry, 2000, ISBN 0-85404-482-5.
-
(2000)
The Royal Society of Chemistry
-
-
Burgess, C.1
-
2
-
-
0010796189
-
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
-
Draft Guidance for Industry, FDA Center for Drug Evaluation and Research (CDER), September
-
Draft Guidance for Industry; Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production, FDA Center for Drug Evaluation and Research (CDER), September 1998.
-
(1998)
-
-
-
3
-
-
84889476550
-
US CGMP regulations
-
(21 CFR§ 211.160 (b)(4))
-
US CGMP regulations (21 CFR§ 211.160 (b)(4)).
-
-
-
-
4
-
-
84889472963
-
The Royal Society of Chemistry
-
AMC Technical Brief No. 13, September
-
AMC Technical Brief No. 13, The Royal Society of Chemistry, September 2003, (http://www.rsc.org/lap/rsccom/amc/amc_index.htm).
-
(2003)
-
-
-
5
-
-
0000790022
-
Analyst
-
M. Thompson and R.J. Howarth. Analyst 105 (1980) 1188-1195.
-
(1980)
, vol.105
, pp. 1188-1195
-
-
Thompson, M.1
Howarth, R.J.2
-
6
-
-
84889469425
-
-
ISO 3534:3.12
-
ISO 3534:3.12.
-
-
-
-
7
-
-
84889269791
-
-
ISO 3534:3.13
-
ISO 3534:3.13.
-
-
-
-
8
-
-
0003703662
-
Quantifying Uncertainty in Analytical Measurement
-
EURACHEM/CITAC Guide, S L R Ellison, M Rosslein, A Williams (Eds), 2nd Edition
-
EURACHEM/CITAC Guide, Quantifying Uncertainty in Analytical Measurement, S L R Ellison, M Rosslein, A Williams (Eds), 2nd Edition, 2000.
-
(2000)
-
-
-
9
-
-
0010857708
-
Reportable values for out-of-specification test results
-
February
-
L.D. Torbeck: Reportable values for out-of-specification test results. Pharmaceutical Technology, Special supplement, February 1999.
-
(1999)
Pharmaceutical Technology
, Issue.SPEC. SUPPL.
-
-
Torbeck, L.D.1
-
10
-
-
0003663974
-
Validation Of Analytical Procedures: Methodology
-
ICH Harmonised Tripartite Guideline Q2B
-
ICH Harmonised Tripartite Guideline Q2B, Validation Of Analytical Procedures: Methodology, 1996.
-
(1996)
-
-
-
11
-
-
84884400014
-
Analytical Chemistry
-
W. Horwitz: Analytical Chemistry, 54 (1982) 67A-76A.
-
(1982)
, vol.54
-
-
Horwitz, W.1
-
12
-
-
0003458464
-
Statistical Process Control
-
2nd edition, Heinemann Newnes, London
-
J.S. Oakland, R.F. Followell: Statistical Process Control, 2nd edition, Heinemann Newnes, London, 1990.
-
(1990)
-
-
Oakland, J.S.1
Followell, R.F.2
-
13
-
-
84889468301
-
Center for Drug Evaluation and Research (CDER) Reviewer Guidance
-
November
-
Center for Drug Evaluation and Research (CDER) Reviewer Guidance, Validation of Chromatographic Methods, November 1994.
-
(1994)
Validation of Chromatographic Methods
-
-
-
14
-
-
84946031884
-
Technometrics
-
F.E. Grubbs: Technometrics, 11(1) (1969)1.
-
(1969)
, vol.11
, Issue.1
, pp. 1
-
-
Grubbs, F.E.1
-
15
-
-
0020750980
-
Technometrics
-
B. Rosner: Technometrics, 25(2) (1983) 165.
-
(1983)
, vol.25
, Issue.2
, pp. 165
-
-
Rosner, B.1
-
17
-
-
0002924740
-
Biometrics
-
W.J. Dixon: Biometrics, 9 (1953) 74-89.
-
(1953)
, vol.9
, pp. 74-89
-
-
Dixon, W.J.1
-
18
-
-
0000519975
-
Analytical Chemistry
-
R.B. Dean, W.J. Dixon: Analytical Chemistry, 23 (1951) 636-638.
-
(1951)
, vol.23
, pp. 636-638
-
-
Dean, R.B.1
Dixon, W.J.2
-
19
-
-
0013247086
-
Analytical Chemistry
-
D.B. Rorabacher: Analytical Chemistry, 63 (1991) 139-146.
-
(1991)
, vol.63
, pp. 139-146
-
-
Rorabacher, D.B.1
-
20
-
-
84916829774
-
Statistical Adjustment of Data
-
W. Edwards Deming: Statistical Adjustment of Data. 1943, 171 (Dover Reprint).
-
-
-
Edwards Deming, W.1
-
21
-
-
34250091204
-
Fresenius Z Anal Chem
-
P.L. Davies: Fresenius Z Anal Chem, 331 (1988) 513-519.
-
(1988)
, vol.331
, pp. 513-519
-
-
Davies, P.L.1
-
22
-
-
84945952294
-
J Amer. Stat. Soc.
-
P.L. Davies: J Amer. Stat. Soc. 88 (1993) 782-801.
-
(1993)
, vol.88
, pp. 782-801
-
-
Davies, P.L.1
-
24
-
-
84889413956
-
-
21 CFR§160(b)
-
21 CFR§160(b).
-
-
-
-
25
-
-
84889307047
-
Analytical Chemistry
-
R. Kellner, J.-M. Mermet, M. Otto, M. Valcörel, H.M. Widmer (Eds.), 2nd Edition, Chapter 6, Analytical Quality Management, 67-89, Wiley-VCH, ISBN 3-527-30590-4
-
C. Burgess in Analytical Chemistry, R. Kellner, J.-M. Mermet, M. Otto, M. Valcörel, H.M. Widmer (Eds.), 2nd Edition, Chapter 6, Analytical Quality Management, 67-89, 2004, Wiley-VCH, ISBN 3-527-30590-4
-
(2004)
-
-
Burgess, C.1
-
26
-
-
0003635329
-
Quality Control in Analytical Chemistry
-
2nd Edition, Section 3.4.2, John Wiley & Sons Ltd
-
G. Kateman, L. Buydens: Quality Control in Analytical Chemistry, 2nd Edition, Section 3.4.2, John Wiley & Sons Ltd., 1993.
-
(1993)
-
-
Kateman, G.1
Buydens, L.2
-
27
-
-
85038078320
-
Statistical Methods in Analytical Chemistry
-
2nd Edition, Section 1.8.4, John Wiley & Sons Ltd.
-
P.C. Meier, R.E. Zund: Statistical Methods in Analytical Chemistry, 2nd Edition, Section 1.8.4, John Wiley & Sons Ltd., 2000.
-
(2000)
-
-
Meier, P.C.1
Zund, R.E.2
-
28
-
-
0004239676
-
Cumulative Sum Techniques
-
Oliver and Boyd for Imperial Chemical Industries Limited, Edinburgh
-
R.H. Woodward, P.L. Goldsmith: Cumulative Sum Techniques, Oliver and Boyd for Imperial Chemical Industries Limited, Edinburgh, 1964.
-
(1964)
-
-
Woodward, R.H.1
Goldsmith, P.L.2
-
29
-
-
0003766997
-
Juran's Quality Handbook
-
5th Edition, McGraw Hill, New York, Section 45.17
-
Juran's Quality Handbook, 5th Edition, McGraw Hill, New York, Section 45.17, 1999.
-
(1999)
-
-
-
30
-
-
84889372298
-
-
Values derived from the nomogram (Figure 12) of British Standard BS 5703 Part II (1980) which was devised using numerical simulation
-
Values derived from the nomogram (Figure 12) of British Standard BS 5703 Part II (1980) which was devised using numerical simulation.
-
-
-
|