-
2
-
-
0039107708
-
-
United States Pharmacopeia 23. Section 1225, United States Pharmacopeia Convention Inc., Rockville, MD
-
United States Pharmacopeia 23. Section 1225, "Validation of Compendial Methods." United States Pharmacopeia Convention Inc., Rockville, MD, 1995, pp. 1982-1984.
-
(1995)
Validation of Compendial Methods
, pp. 1982-1984
-
-
-
3
-
-
85035161932
-
-
Guidance Notes on Applications of Product Licenses (MAL2) A20-7 and A2E-2. HMSO
-
Department of Health Medicines Act 1968, Guidance Notes on Applications of Product Licenses (MAL2) A20-7 and A2E-2. HMSO, 1987.
-
(1987)
Department of Health Medicines Act 1968
-
-
-
7
-
-
0003646348
-
-
Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, Nov
-
"Reviewer Guidance. Validation of chromatographic Methods." Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD, Nov, 1994.
-
(1994)
Reviewer Guidance. Validation of Chromatographic Methods
-
-
-
8
-
-
0003228192
-
-
"International Conference on Harmonization; Guideline on Validation of Analytical Procedures: Definitions and Terminology; Availability." US Department of Health and Human Services (HHS). March 1
-
"International Conference on Harmonization; Guideline on Validation of Analytical Procedures: Definitions and Terminology; Availability." US Department of Health and Human Services (HHS). Federal Register, 60(40), 11260-11265 (March 1, 1995).
-
(1995)
Federal Register
, vol.60
, Issue.40
, pp. 11260-11265
-
-
-
10
-
-
85035166345
-
-
Code of Federal Regulations (21 CFR), April 1
-
Code of Federal Regulations (21 CFR), Foods and Drugs, Parts 200 to 299, April 1, 1994.
-
(1994)
Foods and Drugs
, Issue.200-299 PART
-
-
-
12
-
-
0000353092
-
-
E. Debesis, J. P. Boehlert, T. E. Givand, J. C. Sheridan, Pharm. Technol, 6(9), 120-137 (1982).
-
(1982)
Pharm. Technol
, vol.6
, Issue.9
, pp. 120-137
-
-
Debesis, E.1
Boehlert, J.P.2
Givand, T.E.3
Sheridan, J.C.4
-
17
-
-
3142511615
-
-
D. R. Williams, BioPharm, 5(Nov), 34-36, 51 (1987).
-
(1987)
BioPharm
, vol.5
, Issue.NOV
, pp. 34-36
-
-
Williams, D.R.1
-
18
-
-
0023244958
-
-
A. C. Mehta, Talanta, 34, 609-613 (1987).
-
(1987)
Talanta
, vol.34
, pp. 609-613
-
-
Mehta, A.C.1
-
19
-
-
0023360126
-
-
E. L. Inman, J. K. Frischmann, P. J. Jimenez, G. D. Winkel, M. L. Persinger, B. S. Rutherford, J. Chromatogr. Sci., 25, 252-256 (1987).
-
(1987)
J. Chromatogr. Sci.
, vol.25
, pp. 252-256
-
-
Inman, E.L.1
Frischmann, J.K.2
Jimenez, P.J.3
Winkel, G.D.4
Persinger, M.L.5
Rutherford, B.S.6
-
20
-
-
0000065560
-
-
W. G. DeRuig, R. W. Stephany, G. Dijkstra, J. A. O. A. C., 72, 487-490 (1989).
-
(1989)
J. A. O. A. C.
, vol.72
, pp. 487-490
-
-
DeRuig, W.G.1
Stephany, R.W.2
Dijkstra, G.3
-
22
-
-
0024511806
-
-
G. Szepesi, M. Gazdag, K. Mihalyfi, J. Chromatogr., 464, 265-278 (1989).
-
(1989)
J. Chromatogr.
, vol.464
, pp. 265-278
-
-
Szepesi, G.1
Gazdag, M.2
Mihalyfi, K.3
-
24
-
-
0025383205
-
-
L. M. C. Buydens, J. A. van Leeuwen, M. Mulholland, B. G. M. Vandeginste, G. Kateman. TRAC, 9(2), 58-62 (1990).
-
(1990)
TRAC
, vol.9
, Issue.2
, pp. 58-62
-
-
Buydens, L.M.C.1
Van Leeuwen, J.A.2
Mulholland, M.3
Vandeginste, B.G.M.4
Kateman, G.5
-
25
-
-
3142524212
-
-
P. A. D. Edwardson, G. Bhaskar, J. E. Fairbrother, J. Pharm. Biomed. Anal., 8, 629-637 (1990).
-
(1990)
J. Pharm. Biomed. Anal.
, vol.8
, pp. 629-637
-
-
Edwardson, P.A.D.1
Bhaskar, G.2
Fairbrother, J.E.3
-
26
-
-
0025605035
-
-
A. R Buick. M. V. Doig, S. C. Jeal, G. S. Land, R. D. McDowall, J. Pharm. Biomed. Anal., 8, 629-637 (1990).
-
(1990)
J. Pharm. Biomed. Anal.
, vol.8
, pp. 629-637
-
-
Buick, A.R.1
Doig, M.V.2
Jeal, S.C.3
Land, G.S.4
McDowall, R.D.5
-
27
-
-
0025362288
-
-
M. J. Cardone, S. A. Willavize, M. E. Lacy, Pharm. Res., 7, 154-160 (1990).
-
(1990)
Pharm. Res.
, vol.7
, pp. 154-160
-
-
Cardone, M.J.1
Willavize, S.A.2
Lacy, M.E.3
-
30
-
-
0001646014
-
-
W. L. Paul, Pharm. Technol., 15(March), 130-160 (1991).
-
(1991)
Pharm. Technol.
, vol.15
, Issue.MARCH
, pp. 130-160
-
-
Paul, W.L.1
-
33
-
-
0006153323
-
-
C. Desain, BioPharm., 15, 30-34 (1992).
-
(1992)
BioPharm.
, vol.15
, pp. 30-34
-
-
Desain, C.1
-
37
-
-
0000069766
-
-
G. C. Hokanson, Pharm Tech., 18(Sept), 118-130 (1994).
-
(1994)
Pharm Tech.
, vol.18
, Issue.SEPT
, pp. 118-130
-
-
Hokanson, G.C.1
-
45
-
-
0028936323
-
-
D. Dadgar, P. E. Burnett, M. G. Choc, K. Gallicano, J. W. Hopper, J. Pharm. Biomed. Anal., 13, 89-97 (1995).
-
(1995)
J. Pharm. Biomed. Anal.
, vol.13
, pp. 89-97
-
-
Dadgar, D.1
Burnett, P.E.2
Choc, M.G.3
Gallicano, K.4
Hopper, J.W.5
-
47
-
-
3142597012
-
-
W. Horwitz, ChemTech, 1994(March), 186-191 (1994).
-
(1994)
ChemTech
, vol.1994
, Issue.MARCH
, pp. 186-191
-
-
Horwitz, W.1
|