Guidelines on Bioequivalence

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Announcement

1) Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian BE Synchron Research Services dan Panexcell Clinical Lab Susulan Penemuan Pemeriksaan United States Food and Drug Administration (US FDA)

2) Rejection of Bioequivalence (BE) Studies Conducted at The BE Centres Synchron Research Services and Panexcell Clinical Lab Following Inspection Findings by The United States Food and Drug Administration (US FDA) [Translated Version]

 

Useful Guidance Documents 

1) Malaysian Guideline for BE Inspection, 1st Edition

2) Malaysian Guideline for Application of CTIL and CTX, 7th Edition

3) Manual Permohonan Penilaian Penentuan Keperluan Pemeriksaan Kajian BE

4) Malaysian Guideline for GCP Inspection, Edition 2.1 

5) Malaysian Guideline for Independent Ethics Committee Registration and Inspection, 1st Edition

 

FAQ

1) Desktop Evaluation on The Need of BE Study Specific Inspection

2) Syarat-syarat Tambahan Permohonan BEDE (7 Oktober 2021)