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pharmino ☆ 2012-03-23 16:25 (5211 d 01:18 ago) (edited on 2012-03-24 13:11) Posting: # 8326 Views: 2,558 |
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Dear All, First, let me correct my first post: "Nice page" --> incorrect "Professional page" --> correct Now, I'm used to use the search button, but can't find a thread covering my dilemma which is the following: I was addressed these questions: 1. Check whether the inactive ion metabolized to the stated impurity or not. 2. Check the possibility of measuring the bioavailability of the stated impurity during a biostudy. From where I'm standing it seems not to make any sense. I can't find a reason why these questions are important in the biostudy point of view. In the scientific discussion of the innovator's drug it is stated that "From presented in vitro and in vivo data there are no indications of metabolism, which is expected due its polar and acidic properties" (regarding the inactive ion). But I'm required to present articles on this topic, but since no one cares about the inactive ion's pharmacokinetics there are no articles dealing with this very-very interesting question. Further, I have not met any biostudies yet in which impurities of the inactive ion of the salt was measured. Is it because of lack of experience or am I right? Many thanks in advance. * I edited the original post because it came up in the third place when I Googled for the exact API and impurity which may be disadvantageous for me. Sorry. |
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Dr_Dan ★★ Germany, 2012-03-26 13:14 (5208 d 05:30 ago) @ pharmino Posting: # 8334 Views: 1,966 |
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Dear pharmino I experienced a similar situation and my reply to the assessor's comment was something like this: The purpose of a bioequivalence study is not to describe the full pharmacokinetics of a drug entity (or all metabolization steps) but to detect differences between galenic formulations. Evaluation of bioequivalence should be based upon measured concentrations of the parent compound. The requested information should have been provided by the originator. If your product satisfies the criteria of having the same qualitative and quantitative composition in terms of active principles and of having the same pharmaceutical form, then the generic nature is given and it is evident that all data available for the original product also apply for your preparation. Therefore your application refers to Article 10, Directive 2001/83/EC, as amended. The whole information on pharmaco-toxicological and clinical experience can be transferred from the originator product to your product and you do not need to provide additional data. Of course the assessor did not like that answer but finally he had to accept it. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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