[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

[aid]

We know bioequivalence studies are generally performed on the highest strength of a product.

When can a Bioequivalence study be performed on a lower strength where the applied product has multiple strengths?

[Pharma Digests]

As per EMA guideline in following scenarios lower strength can consider:

1. If the highest strength cannot be administered to healthy volunteers for safety/tolerability reasons. for example: antipsychotic drugs

2. If the pharmacokinetics of the drug is non linear, that means AUC doesn’t increase in proportion to dose administered, and if there is less than proportional increase in AUC due to saturation of uptake mechanism and there are no excipients that alter GI motility or transport proteins.

Do let me know if you know any other situations when BE is acceptable only on the lower strength.

Second scenario is a little complicated to understand, just do a little research to understand it better.

[Author]

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