-
1
-
-
34547733084
-
-
Sobol, E.; Engel, M. E.; Rubitski, E.; Ku, W. W.; Aubrecht, J.; Schiestl, R. H. Mutat. Res. 2007, 633, 80
-
(2007)
Mutat. Res.
, vol.633
, pp. 80
-
-
Sobol, E.1
Engel, M.E.2
Rubitski, E.3
Ku, W.W.4
Aubrecht, J.5
Schiestl, R.H.6
-
3
-
-
33645840463
-
-
Muller, L.; Mauthe, R. J.; Riley, C. M.; Andino, M. M.; Antonis, D. D.; Beels, C.; DeGeorge, J.; De Knaep, A. G.; Fagerland, J. A.; Ellison, D.; Frank, R.; Fritschel, B.; Galloway, S.; Harpur, E.; Humfrey, C. D.; Jacks, A. S.; Jagota, N.; Mackinnon, J.; Mohan, G.; Ness, D. K.; O'Donovan, M. R.; Smith, M. D.; Vudathala, G.; Yotti, L. Regul. Toxicol. Pharmacol. 2006, 44, 198
-
(2006)
Regul. Toxicol. Pharmacol.
, vol.44
, pp. 198
-
-
Muller, L.1
Mauthe, R.J.2
Riley, C.M.3
Andino, M.M.4
Antonis, D.D.5
Beels, C.6
Degeorge, J.7
De Knaep, A.G.8
Fagerland, J.A.9
Ellison, D.10
Frank, R.11
Fritschel, B.12
Galloway, S.13
Harpur, E.14
Humfrey, C.D.15
Jacks, A.S.16
Jagota, N.17
MacKinnon, J.18
Mohan, G.19
Ness, D.K.20
O'Donovan, M.R.21
Smith, M.D.22
Vudathala, G.23
Yotti, L.24
more..
-
4
-
-
55849151593
-
-
EMEA Committee for Medicinal Products for Human Use, CPMP/SWP/5199: London, England.
-
Guideline on the Limits of Genotoxic Impurities; EMEA Committee for Medicinal Products for Human Use, CPMP/SWP/5199: London, England, 2006.
-
(2006)
Guideline on the Limits of Genotoxic Impurities
-
-
-
5
-
-
77955411749
-
Subpart B: Food Additive Safety, Section 170.39: Threshold of Regulation for Substances Used in Food-Contact Articles, Revised April 1, 2007
-
Title 21, Food and Drugs; Office of the Federal Register, National Archives and Records Service, General Services Administration: Washington, DC,; Chapter 1, Vol.
-
Subpart B: Food Additive Safety, Section 170.39: Threshold of Regulation for Substances Used in Food-Contact Articles, Revised April 1, 2007. Code of Federal Regulations; Title 21, Food and Drugs; Office of the Federal Register, National Archives and Records Service, General Services Administration: Washington, DC, 2007; Chapter 1, Vol. 3.
-
(2007)
Code of Federal Regulations
, vol.3
-
-
-
7
-
-
77955349920
-
-
Draft; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER): Rockville, MD.
-
Guidance for Industry, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches, Draft; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER): Rockville, MD, 2008.
-
(2008)
Guidance for Industry, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches
-
-
-
12
-
-
77955392664
-
-
The approach described in this paper is likely similar to others industry wide. In designing this methodology, focus was directed at generating strong process understanding through the use of QbD whereby robust control points can be identified, thus ensuring patient safety.
-
The approach described in this paper is likely similar to others industry wide. In designing this methodology, focus was directed at generating strong process understanding through the use of QbD whereby robust control points can be identified, thus ensuring patient safety.
-
-
-
-
13
-
-
78650213334
-
ICH Q3A(R2). Impurities in New Drug Substances
-
In; ICH Expert Working Group: Geneva, Switzerland.
-
ICH Q3A(R2). Impurities in New Drug Substances. In International Conference on Harmonisation, Harmonised Tripartite Guideline; ICH Expert Working Group: Geneva, Switzerland, 2006.
-
(2006)
International Conference on Harmonisation, Harmonised Tripartite Guideline
-
-
-
14
-
-
77955342764
-
-
The following are definitions for observed and potential impurities. Observed impurity: impurity detected in isolated batches of starting material, intermediate, or API. Potential impurity: impurity seen during process, but not detected in starting material, intermediate, or API
-
The following are definitions for observed and potential impurities. Observed impurity: impurity detected in isolated batches of starting material, intermediate, or API. Potential impurity: impurity seen during process, but not detected in starting material, intermediate, or API
-
-
-
-
15
-
-
77955351017
-
-
Alternatively, one could perform the appropriate genotoxicity assays on these higher-risk PGIs prior to conducting further studies. If negative in these assays, no further work would be required. If positive, however, agencies would likely require their specification in the API. Under our approach, if the PGI is ultimately deemed noncritical, specification in the API would not be necessary, thus avoiding longer-term low-level detection requirements during commercial production.
-
Alternatively, one could perform the appropriate genotoxicity assays on these higher-risk PGIs prior to conducting further studies. If negative in these assays, no further work would be required. If positive, however, agencies would likely require their specification in the API. Under our approach, if the PGI is ultimately deemed noncritical, specification in the API would not be necessary, thus avoiding longer-term low-level detection requirements during commercial production.
-
-
-
-
16
-
-
77955374688
-
-
For discussions on the mechanistic pathway of nitroaromatic hydrogenation chemistry, please see
-
For discussions on the mechanistic pathway of nitroaromatic hydrogenation chemistry, please see
-
-
-
-
18
-
-
77955385600
-
-
The design spaces for the crystallization and isolation procedures were evaluated separately.
-
The design spaces for the crystallization and isolation procedures were evaluated separately.
-
-
-
-
19
-
-
77955369252
-
-
For information on multiple regression analysis, please see
-
For information on multiple regression analysis, please see
-
-
-
|