Non-inferiority trials

Smooth Drug Development offers services on therapeutic equivalence studies for drug registration.
To register a generic drug, for which the originator has been on the market less than 20 years, and for which a bioequivalence study conduct is not possible, within the registration dossier it is required to provide producer`s own data on pre-clinical studies (in case of full sameness of drug composition to that of the originator, it is allowed to provide literature data on the originator product) and on a therapeutic equivalence study.
Such studies are conducted in order to confirm that the generic product has the same therapeutic effect as the originator.
The design, endpoints and statistical approach of such studies are elaborated as in phase III studies.
Therapeutic equivalence studies are conducted in order to register products, for which a bioequivalence study is not possible, or in parallel with such studies to show that the drug is not just absorbed and distributed identically to as it is with the originator, but that it also has the same therapeutic effect.
Also, as requested by Sponsor, a therapeutic equivalence study may be conducted instead of a bioequivalence study for registration purpose. Such studies are conducted at several sites, its peculiarity is to select the most widespread therapeutic sphere and –since they deal with known drugs –stick to tight timelines.
Our company has extensive experience in conduct of therapeutic equivalence studies, starting from documentation elaboration up to clinical study report writing.
We work with a number of clinical sites specializing in the most widespread therapeutic areas and which have proven their capacity for good enrollment and good quality of data and documentation.
Smooth Drug Development conducts therapeutic equivalence studies since 2011.