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Reformulation
What are some of the regulatory, technical, and clinical hurdles that could potentially impact efforts to reformulate an OTC drug in a new topical application? How might such hurdles be avoided or mitigated to achieve efficient consumer testing?
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At minimum, one needs to demonstrate “bioequivalence” of the new formulation in terms of pharmacokinetics (ADME - administration, distribution, metabolism, elimination), and also its safety.
Further, the new formulation should offer an advantage to patients; why else should a regulatory agency approve a new formulation?
If the formulation is novel, it could be patented; if we talk about a generic drug, its patent would have expired so the drug could be a part of this invention, perhaps.