Biopharmaceutics classification system

Validation
1

Could you provide me links about BCS classification as per FDA .I’m looking for Azithromycin classification , in Pharma specialists database I found that is classified III and IV, WHO classification IV, I need information about class III.

Thanks

2

Please refer to ICH guidelines as follows,
BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS (M9), Final version
Adopted on 20 November 2019
OR
M9 Biopharmaceutics Classification SystemBased Biowaivers
Guidance for Industry by USFDA (CDER, CBER), May 2021
Following is the link of the USFDA

https://www.fda.gov/media/148472/download#:~:text=II.-,BIOPHARMACEUTICS%20CLASSIFICATION%20OF%20THE%20DRUG%20SUBSTANCE%20(2),permeability%20(BCS%20Class%20III).

Additional information:
Conflicting evidence has been found regarding the BCS classification of azithromycin. According to the FDA Zithromax® Clinical Pharmacology and Biopharmaceutics review, azithromycin might be either a BCS class I or III compound.12 On the other hand, WHO has classified azithromycin as BCS class II (poor solubility) or IV (poor solubility and permeability) compound.

Reference:
Investigating the Critical Variables of Azithromycin Oral Absorption Using In Vitro Tests and PBPK Modeling,
Journal of Pharmaceutical Sciences
Volume 110, Issue 12, December 2021, Pages 3874-3888

1 Like
3

Thank you so much this conflicting poses a problem to choose the
right BCS classification.
Best regards

4

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