EMA/ICH - The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been adopted

The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been fully adopted on 23 July 2024. This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post-approval phases for orally administered immediate-release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. Deviations from the recommendation...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2024-10-19
DOI
https://doi.org/10.58079/12j9d
Primary Topic
Drug Solubulity and Delivery Systems
Type
article
Field-Weighted Citation Impact
0.00
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article

EMA/ICH - The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been adopted

Industrias Culturais (Universidade de Coimbra)
Drug Solubulity and Delivery Systems
article

EMA/ICH - The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been adopted

article en

Abstract

The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been fully adopted on 23 July 2024. This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post-approval phases for orally administered immediate-release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. Deviations from the recommendation...

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 66%
Drug Solubulity and Delivery Systems
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EMA/ICH - The ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms has been adopted · Industrias Culturais (Universidade de Coimbra) (2024) | TGRS Research Map | TGRS