EMA – Publication of a Question and answers on ICH M12 Guideline on drug interaction studies

In response to questions posted to ICH M12 comment period, several Questions and Answers have been developed to provide clarity around some of the concepts related to evaluation of drug interaction covered in the Guideline. This Question and Answer (Q&A) document is intended to provide additional clarification and improve harmonization of drug interaction assessment. The scope and organization of this Q&A document follow that of ICH M12. More information on the ICH M12 Guideline on drug inte...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2024-10-19
DOI
https://doi.org/10.58079/12j9p
Primary Topic
Schizophrenia research and treatment
Type
article
Field-Weighted Citation Impact
0.00
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article

EMA – Publication of a Question and answers on ICH M12 Guideline on drug interaction studies

Industrias Culturais (Universidade de Coimbra)
Schizophrenia research and treatment
article

EMA – Publication of a Question and answers on ICH M12 Guideline on drug interaction studies

article en

Abstract

In response to questions posted to ICH M12 comment period, several Questions and Answers have been developed to provide clarity around some of the concepts related to evaluation of drug interaction covered in the Guideline. This Question and Answer (Q&A) document is intended to provide additional clarification and improve harmonization of drug interaction assessment. The scope and organization of this Q&A document follow that of ICH M12. More information on the ICH M12 Guideline on drug inte...

Industrias Culturais (Universidade de Coimbra)
Good health and well-being
Openalex Percentile: Top 56%
Schizophrenia research and treatment
DOIOpen Access PDFOpenAlex
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EMA – Publication of a Question and answers on ICH M12 Guideline on drug interaction studies · Industrias Culturais (Universidade de Coimbra) (2024) | TGRS Research Map | TGRS