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1.
In silico prediction of pharmaceutical degradation pathways: a benchmarking study.
Mol Pharm
; 11(11): 4179-88, 2014 Nov 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-25364862
2.
Pharmaceutical Forced Degradation (Stress Testing) Endpoints: A Scientific Rationale and Industry Perspective.
J Pharm Sci
; 112(12): 2948-2964, 2023 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-37690775
3.
Assessing the Relevance of Solution Phase Stress Testing of Solid Dosage Form Drug Products: A Cross-Industry Benchmarking Study.
J Pharm Sci
; 111(2): 298-305, 2022 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-34111446
4.
Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 2: Safety considerations of impurities in pharmaceutical products and surveying the impurity landscape.
AAPS PharmSciTech
; 15(1): 237-51, 2014 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-24363207
5.
Recent trends in product development and regulatory issues on impurities in active pharmaceutical ingredient (API) and drug products. Part 1: Predicting degradation related impurities and impurity considerations for pharmaceutical dosage forms.
AAPS PharmSciTech
; 15(1): 198-212, 2014 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-24281749
6.
Degradation Rate Observations as a Function of Drug Load in Solid-State Drug Products.
J Pharm Sci
; 108(5): 1746-1755, 2019 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-30550816
7.
The Degradation Chemistry of Prasugrel Hydrochloride: Part 1-Drug Substance.
J Pharm Sci
; 108(9): 2842-2857, 2019 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-30981754
8.
Isolation, identification, and synthesis of two oxidative degradation products of olanzapine (LY170053) in solid oral formulations.
J Pharm Sci
; 97(2): 883-92, 2008 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-17879984
9.
Artifactual degradation of secondary amine-containing drugs during accelerated stability testing when saturated sodium nitrite solutions are used for humidity control.
J Pharm Biomed Anal
; 149: 206-213, 2018 Feb 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-29126082
10.
Mechanistic Studies of the N-formylation of Edivoxetine, a Secondary Amine-Containing Drug, in a Solid Oral Dosage Form.
J Pharm Sci
; 106(5): 1218-1238, 2017 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-28159638
11.
Formation of copper(I) from trace levels of copper(II) as an artifactual impurity in the HPLC analysis of olanzapine.
J Pharm Biomed Anal
; 125: 186-93, 2016 Jun 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-27023131
12.
Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 3. Oral Drug Products.
J Pharm Sci
; 105(5): 1586-1594, 2016 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-27056630
13.
Determination of the Degradation Chemistry of the Antitumor Agent Pemetrexed Disodium.
J Pharm Sci
; 105(11): 3256-3268, 2016 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-27539558
14.
Artifacts Generated During Azoalkane Peroxy Radical Oxidative Stress Testing of Pharmaceuticals Containing Primary and Secondary Amines.
J Pharm Sci
; 104(12): 4287-4298, 2015 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-26565996
15.
Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 2: Topical Drug Product.
J Pharm Sci
; 104(9): 2688-701, 2015 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-25711373
16.
Investigation of the mechanism of racemization of litronesib in aqueous solution: unexpected base-catalyzed inversion of a fully substituted carbon chiral center.
J Pharm Sci
; 103(9): 2797-2808, 2014 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-24633856
17.
The assessment of impurities for genotoxic potential and subsequent control in drug substance and drug product.
J Pharm Sci
; 102(5): 1404-18, 2013 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-23436613
18.
On-column nitrosation of amines observed in liquid chromatography impurity separations employing ammonium hydroxide and acetonitrile as mobile phase.
J Chromatogr A
; 1319: 57-64, 2013 Dec 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-24182763
19.
Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products administered by injection.
J Pharm Sci
; 102(11): 3888-99, 2013 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-24009146
20.
A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision.
J Pharm Sci
; 99(7): 2934-40, 2010 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-20135694
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