Guideline on Equivalence Studies for the Demonstration of Therapeutic Equivalence for Products that are Locally Applied, Locally Acting in the Gastrointestinal Tract
A few weeks ago, the EMA published a draft guidance the defines the in vitro and in vivo requirements to demonstrate equivalence for locally acting GI products. Altasciences has been at the forefront of the clinical research of locally acting GI products, as we have conducted more than 80 clinical studies on products such as Mesalamine (5-ASA). As discussed in the draft guidance, the studies required for locally acting GI products range from in vitro assessments to in vivo bioequivalence pharmacokinetic studies to therapeutic equivalence studies, but exactly which studies are required depend on the product. Products that show some degree of drug absorption and systemic bioavailability require a bioequivalence study in order to address systemic safety. This is the case with Mesalamine, which is absorbed systemically.
At Altasciences, we have worked on multiple formulations of Mesalamine, from rectal enema to suppository, oral delayed-release and oral sustained-release products. We can apply this experience to designing and performing bioequivalance studies on a number of other locally acting GI products.