Part III New Chemical Entity

A : Table of Content

B : Non-Clinical Overview

Ref. PART III: NONCLINICAL DOCUMENT of the ASEAN Common Technical Dossier (ACTD)

The primary purpose of nonclinical written and tabulated summaries should be to provide a comprehensive, factual synopsis of the nonclinical data. The interpretation of the data, the clinical relevance of the findings, cross-linking with the quality aspects of the pharmaceutical, and the implications of the nonclinical findings for the safe use of the pharmaceutical (i.e. as applicable to labeling) should be addressed in the nonclinical overview.

Please refer:

The ASEAN Common Technical Dossier (ACTD) for the Registration of Pharmaceuticals For Human Use – Part III : Nonclinical Document

B1 : Overview of the Non-Clinical Testing Strategy

Please refer:

The ASEAN Common Technical Dossier (ACTD) for the Registration of Pharmaceuticals For Human Use – Part III : Nonclinical Document

B2 : Pharmacology

Please refer:

The ASEAN Common Technical Dossier (ACTD) for the Registration of Pharmaceuticals For Human Use – Part III : Nonclinical Document

B3 : Pharmacokinetics

Please refer:

The ASEAN Common Technical Dossier (ACTD) for the Registration of Pharmaceuticals For Human Use – Part III : Nonclinical Document

B4 : Toxicology