Comments to published Biowaiver Monographs

Comments to published Biowaiver Monographs

Comments and new data to published Biowaiver Monographs can be posted by sending an email with the form below. In particular, data not yet covered in the monograph are most wellcome! Please, name the Biowaiver Monograph your new message concerns. Disclaimer: The content of items posted in the Discussion Forum represents the opinion of the submitting author(s). It should not be construed as representing the opinion of either the Special Interest Group or the FIP. Alan Parr, Moderator of the Discussion Forum. 

“BCS class for topical proucts”

Dixit Yogi wrote:

I need comment on consideration of BCS class for topical proucts. Do it really required to be considered?


Alan Parr wrote:         

We would recommend that you review a paper by V. Shah et. al. (A science based approach to topical drug classification system (TCS), International Journal of Pharmaceutics 491 (2015) 21–25) for guidance in this area.  Additionally, the FDA has SUPAC guidelines for topical products that you should review as well.



“Biowaiver for Bisoprolol”

Mir Shahroz wrote:

This is regarding Bisoprolol tablets&59#;\r\nAny one have any references of any regulatory agency (WHO, US-FDA, EU, ANVISA MCC, TFDA, etc.) which confirm Biowaiver for Bisoprolol tablets?? \r\n\r\nIn WHO&59#; there is a proposal but not included till now.


Alan Parr wrote:

A monograph for immediate-release solid oral dosage forms for bisoprolol fumarate does exists (please see monograph section of our website ( ) for this monograph) and we would refer you to this monograph since it should be able to address your question on this topic.



“Diclofenac Biowaiver monograph”

Christos Reppas wrote:
Monday 29-11-2010

In the biowaiver monograph for diclofenac (JPS 2009), Table 3, the solubility in pH 3.0 is not in line with the rest of the solubility 
data. Is this a typo or this is the correct number indeed? 

changed Wednesday 06-04-2011


Alan Parr wrote:
Wednesday 22-12-2010

Dear Dr. Reppas,

I checked with the author of the diclofenac monograph and he indicated that the solubility value in question was accurately reported from the literature. The author also indicated that this value was not experimentally tested, but was taken directly from the literature. Please note that the manuscript that this value came from is actually reference article #29 instead of the reference article #19 which was listed in the monograph. Please let me know if you have any additional questions about this topic.
changed Tuesday 05-04-2011



Christos Reppas wrote:
Monday 04-04-2011

Dear Dr Parr, thank you for replying back to me.
No further questions.

“Rifampicin Biowaiver Monograph”

Monday 17-08-2009

I have read your article "Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Rifampicin" published in JPS
(online) with lots of interest. It has a compilation of all the literature reports of solubility and permeability characteristics of Rifampicin. However, the whole article missed
out an important and relevant article from our laboratory (from NIPER, Mohali, India), which also discusses about the same subject. It has been published in Clinical Research and
Regulatory Affairs, 23(1):1–10, (2006). This article describes rifampicin as BCS class IV compound, based on the solubility and
permeability results obtained from our laboratory as well as the published literature.
Dr. T. Thanga Mariappan, Senior Scientist,
Piramal Health Care Ltd, Mumbai, India.
changed Tuesday 18-08-2009

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