[Pharma Digests]

How difficult is it for generics to prove bioequivalence?

[aid]

It’s depend on molecule nature, dosage form, patient availability etc.

But there are stringent requirements for a generic drug to be claimed bioequivalent to a reference product. One requirement is that the bioavailability of the generic product should be closely similar to that of the reference product.

[FRD]

Which physicochemical properties of API should be considered for Bio study?

[aid]

@FRD
You should consider at least below physicochemical properties of API:
– Solubility of API
– pKa, LogP value of API
– Absorption site of API

[Author]

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