Comments to published Biowaiver Monographs

 General Opinion on Monographs

"...for our Agency those monograph in some situations are very helpful. Primarily, when applicant submits documentation for variation type II -changes in formulation in post-marketing phase of drug life cycle - the decision whether in vivo BE study is necessary or not, may be made, partly, based on your monographs. As you know SUPAC guideline does not recognize the possibility to waive the in vivo BE study if any qualitative change in formulation is made. However we consider that some excipients may be replaced with another only if appropriate in vitro investigations are performed and in this situation consultation with your monograph about all necessary details connected with the excipients could be essential. Also, we find that information about solubility, permeability and dosage form 'behavior' very reliable, ... So, BCS drug classification can be performed more easily." Mr. Ivan KovaCevic & Marija Ilic, Medicines and Medical Devices Agency of Serbia.


“Copyright of published monographs”

Sharif Ahmed wrote:
Saturday 28-07-2012

I wanted to know if the biowaiver monographs can be published as part of other books or journals. Are these copyrighted material. If they are how do we seek permission?

Replies to this question: 

Alan wrote:
Wednesday 05-09-2012

The biowaiver mongraphs are copyright protected and as such any use of these monographs requires approval from the orginating source (in this case JPS). Should you wish to use these materials please request apprpriate permission. This response is from the BCS & Biowaivers Special Interest Group (SIG).

“biowaiver of the drug again”

ahmad wrote:
Wednesday 15-12-2010

If biowaiver of one drug is done in one country ,can it be done in another country?

Replies to this question: 

Alan Parr wrote:
Wednesday 22-12-2010

The decision to accept or not accept a biowaiver for a given molecule/product is made by the specific regulatory agency that the biowaiver is being filed with. Since this decision is made by each individual regulatory agency it is possible for a biowaiver to be accepted by multiple countries, but it is also possible that a biowaiver could be allowed by one country and not another. You will need to check with the country of interest as to whether they will or will not accept a biowaiver for the compound/product in question.

“Relevance of Biowaiver Monographs”

Petteri Malkavaara wrote:
Monday 02-11-2009

I have read the BCS and Biowaiver topic with interest and found the biowaiver monographs to be particularly relevant in my work (I am responsible for the study protocols of our clinical trials).
changed Monday 02-11-2009

Replies to this question: 

Alan Parr wrote:
Wednesday 15-02-2012

The SIG on BCS appreciates your positive comment.



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