Comments to published Biowaiver Monographs


Comments and new data to published Biowaiver Monographs can be posted clicking the link and then using the "Post a new message" option. 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.

 

 

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.

 

 

Question & Answer


Any questions with respect to biowaivers? Post your question here- maybe, another worker in this field posts an answer. Alan Parr, Moderator of the Discussion Forum. 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.