Bioequivalence Guidelines

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Guidelines on Bioequivalence

: Posted By Nabila; 12 Jun 2018; Jumlah paparan: 21825

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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 Permohonan BEDE

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( 9 Ratings )

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

Email: npra@npra.gov.my
Phone: +603-7883 5400
Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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Guidelines on Bioequivalence

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