Bioavailability &
Bioequivalence
studies
Gain First-to-Market Advantage with
our BA/BE and Phase I PK services
Bioavailability &
Bioequivalence
studies
Gain First-to-Market Advantage with
our BA/BE and Phase I PK services
Be First-to-Market with our Bioavailability & Bioequivalence (BABE) CRO Services
Bioavailability (BA) and Bioequivalence (BE) studies are carried out for developing a new formulation or for marketing a generic drug. In order to market a generic drug, BABE studies are required for approval from health authorities like US FDA. The drug that is being tested is studied against a well- known and commercially available drug, at same concentrations and under conditions that are similar. Companies file their Abbreviated New Drug Application (ANDA) according to 505 (j) or 505b (2) to the US FDA for marketing authorization in USA. Selection of the right clinical research organization is vital for a successful market launch.
With over 90% of the prescriptions in the US market being fulfilled by generics companies, the competition in this space is growing exponentially. This makes it imperative for generics companies to be first-to-market, while adhering to stringent regulatory requirements, ensuring high quality outputs, and maintaining a cost advantage. Navitas Life Sciences is the leading clinical research organization (CRO) with over 100+ marketing authorizations obtained through bioavailability and bioequivalence (BABE) studies. Our capabilities include
BABE Capabilities
Generics
Modified release
Complex generics
Clinical endpoint bioequivalence studies
Special studies
Inhalation studies
Bring Your Generic Product to Market Quickly & Effectively with Our End-to-End Services
Design & plan your study with our experts to ensure successful outcomes
Complex Generics
Complex generics are generic products with a complex active ingredient, complex route of delivery or even a complex formulation. Conducting BABE studies for complex generics requires specialized expertise over that required for simple generics. There is a need for better planning, quality and regulatory assessment, in order to bring complex generics drugs to market. At Ecronacunova, we adapt our studies to address these challenges and to ensure first to market strategy, for exclusivity and for better patient benefit. We have supported multiple companies in filing for both 505 (j) or 505b (2) pathways as required by US FDA for marketing authorization.
Proven Expertise
The ever-growing pharmaceutical industry and innovations in drug development necessitate competency to carry out a wide variety of studies. Ecronacunova have proven expertise in a wide variety of studies which include variation in doses, dosage forms, single and double blind, dose escalation, PK/PD end point studies, Glucose clamp studies, proof of concept and exploratory, repeat “first in man”, nutritional, special population, drug interaction, injection study, inhalation study and many more. We understand the strategic importance of delivering high quality studies which is why we have an impressive record with the FDA
Be first-to-market with your generic product
Get Yourself The Ecron Acunova Edge
Ecronacunova brings together domain experts to cater to your bioequivalence and bioavailability study requirements
Ecronacunova brings together domain experts to cater to your bioequivalence and bioavailability study requirements
Your preferred partner for end-to-end BA/BE studies
Leverage Any of Our 450+ Validated Bioanalytical Methods For Your Study
In case we don’t have the method you need already, our Bioanalysis experts can develop a validated method for you within 4 weeks
Leverage Any of Our 450+ Validated Bioanalytical Methods For Your Study
In case we don’t have the method you need already, our Bioanalysis experts can develop a validated method for you within 4 weeks
Right Infrastructure
Inhalation Chambers
Right Infrastructure