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1.
Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Guidelines on Model Fitting and Recommendations on Time Course for In Vitro Cytochrome P450 Induction Studies Including Impact on Drug Interaction Risk Assessment.
Drug Metab Dispos
; 49(1): 94-110, 2021 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-33139460
2.
Perspectives from the Innovation and Quality Consortium Induction Working Group on Factors Impacting Clinical Drug-Drug Interactions Resulting from Induction: Focus on Cytochrome 3A Substrates.
Drug Metab Dispos
; 47(10): 1206-1221, 2019 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-31439574
3.
Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance.
Drug Metab Dispos
; 46(9): 1285-1303, 2018 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-29959133
4.
Risk/science-based approach to validation: a win-win-win for patients, regulators, and industry.
PDA J Pharm Sci Technol
; 58(1): 15-23, 2004.
Artículo
en Inglés
| MEDLINE | ID: mdl-15053051
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