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Beer and a bupropion HCl chaser? US FDA issues draft BE guidance

By Gareth MacDonald+


Drugmakers seeking ANDAs for certain solid dose, extended-release drugs will need to test what impact alcohol has on their products under new draft guidance on bioequivalence issued by the US FDA.

The suggestion that: “An in vivo BE study of the drug product when administered with alcohol may be suggested in some cases” is just one recommendation in the draft guidance  that was issued to clarify what developers must do to prove their products are equivalent to reference drugs.

The document – which is being made available for stakeholder comments until March next year - sets out general the study characteristics that developers must use to determine bioequivalence, most of which involve measuring how quickly and how much of a drug active pharmaceutical ingredient (API) reaches its target.


The guidance also highlights some of the specific tests that are only applicable to some dosage forms.

For ANDA applicants developing some extended release solid oral dosage forms in vitro studies will be enough to assess the impact alcohol has on API release, but for others more extensive testing will according to the FDA which refers developers product-specific guidance.

In addition to covering aspects of bioequivalence testing that enable eye-catching headlines, the draft guidance also covers the FDAs testing requirements for developers seeking ANDAs for other drug dosage forms.

Equivalence in Europe

Publication of the new guidance document comes a few weeks after the US Food and Drug Administration's (FDA) counterpart, the European Medicines Agency (EMA) published its first set of product specific bioequivalence guidelines.

At the time the EMA said that the 16 guidance documents - coveringcapecitabine; carglumic acid; dasatinib; emtricitabine/tenofovir disproxil; erlotinib; imatinib; memantine; miglustat; oseltamivir; posaconazole; repaglinide; sirolimus; sorafenib; tadalafil; telithromycin; voriconazole - would "help companies design study programmes that meet the expectations of European Union regulators, allowing for better transparency and predictability of the scientific assessment during the authorisation process."

The European regulatory agency is expected to produce another raft of specific testing requirements next year.

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