Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on January 5, 2024 by The Health Master
BA / BE Studies
What is BA / BE
Bioavailability (BA): Bioavailability refers to the relative amount of drug from an administered dosage form which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.
Bioequivalence (BE): Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.
Also read: Suggestion on bio-equivalence studies under Rule 122 DAA
DCGI Notices
2021
DCGI dt 02-08-2021 – Updated list of BA-BE Study centre & Bio Analytical Laboratory under New CT RULE 2019
2020
DCGI Notice 13-03-20 – Requirement of process validation report for permission to conduct Clinical trial / BA-BE studies
DCGI has issued notice on 21-02-2020 regarding sub acute toxicity study report for injectable products for BA BE study in human for export
DCGI has issued notice on 21-02-2020 regarding stability data for BA BE study in human for export
DCGI has issued notice on 21-02-2020 regarding Processing of application for BA BE permission issued in Form CT-07 import license issued in CT-17
DCGI has issued notice on 21-02-2020 regarding permission to conduct BA BE studies and clinical trial
DCGI has issued a notice 27-01-2020 regarding Processing of post approval to BA BE permission issued in Form CT-07, import license issued in CT-17
DCGI has issued a notice 22-01-2020 regarding – List of Reference Products for Conduct of BE Study. Click below for more information:
How to obtain approval of BA / BE
The list of documents required for BA or BE approval is provided below. Download the pdf file and prepare the documents accordingly.
List of approved BA / BE Centres
Download the below pdf files for list of approved BA / BE Centres
List of registered BA BE Study Centres and & Bio Analytical Laboratories under New CT Rules 2019 as on 31-01-2023
List of BA-BE approved Centres as on 02-08-2021, click below link
List-of-BA-BE-approved-Centres- as on 02-08-2021
List of BA / BE approved Centres as on 10-06-2021, click below link
List of BA / BE approved Centres as on 29-02-2019, click below link
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BA / BE Studies: Bioavailability & Bioequivalence
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
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