Article

International Regulations for Bioequivalence Approval of Locally Acting Orally Inhaled Drug Products

2021-01-09

Abstract excerpt

Bioequivalence (BE) is established between the brand drug and the generic drug to allow the linking of preclinical and clinical testing conducted on the reference listed drug. Regulatory agencies around the globe have come up with the guidance for locally acting orally inhaled drug products (OIDPs) for bioequivalence approaches. The prime intent of the present article is to compare approaches of different internat...

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Literature Corpus work: bde7f733-37ae-5b82-bee2-975f84781f98
DOI: 10.22541/au.161019131.19061881/v1

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