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I would like to know what parameter should we include in TPP (target product profile) preparation of a new molecule in terms of DMPK profile.
Eagerly waiting for your expert comment.
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The following message was posted to: PharmPK
Good question, indeed.
I am no big expert, but according to my experience, there may not be one definite answer: that would depend on the intended ultimate use of the drug in therapy, on anticipated issues in development, on projected market...
For instance, in the case of early CYP inhibition data:
- for an oral antihypertensive drug to be taken daily by the patient for years, the risk of drug-drug interaction may turn out to be important both for current therapeutic practice and with regards to the number of competitive drugs already on the market; in such a context, CYP inhibition should probably be considered - on the contrary, for an antibiotic to be given IV in the case of critical infection and for a period of time not exceeding 2-3 weeks, the DDI risk may not be as important, especially if there is no other drug on the market (because of antibiotic resistance, for instance); in that case, the rationale of inclusion of CYP inhibition in the TPP is much weaker.
You may have to decide what property is really relevant for compound selection (and then, what the threshold value would be). Quite challenging, but isn't that nice? Best of luck
Frederic Massiere, Novexel
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