Bioavailability (BA) and Bioequivalence (BE) studies are important for both marketing generic products and developing a new chemical entity. For the former, these are the quintessential studies required for approval. The potential to-be-marketed generic product (test product) is examined against a commercially-available brand product (reference product) under the same molar dose and under similar conditions to confirm that the mean plasma concentration over time is comparable. Key pharmacokinetic parameters examined include area under the curve (AUC), peak concentration (Cmax), and time to peak concentration (Tmax). For new chemical entities, obtaining PK data early in clinical development establishes understanding of a PK/PD (pharmacodynamic) phenomenon which will provide the critical link to understanding dosing and appropriate Phase 3 clinical design.
The MENA region such asJordanandAlgeriais establishing itself as a new destination for these trials. These locations provide key advantages such as reduced timelines, lower cost and most important, reliable and robust data accepted by the regulatory agencies.
A recent article in the Journal of Clinical Studies Volume 6, issue 2, 2014* describes that the increase demand for Bioavailability (BA) and Bioequivalence (BE) studies has attracted global attention. Sponsors are conducting BA/BE studies in emerging economies while using and relying on quality local CROs to take advantage of the cost-benefit analysis to yield a quality study in a stipulated time. Sponsors are moving from the usual regions such as US, Japan, Australia, and EU that have strict regulatory constraints leading to delays and higher costs to regions such as Africa and India. Surveys have shown that data generated from these regions are as reliable as more established regions such North America and Western Europe (see our previous blog dated April 15, 2014).
The general regulatory considerations for BA/BE studies include study design and protocol, bioanalysis, selection of appropriate analytes, BE metric and data treatment, and statistical approaches and analysis. In a small survey for Sponsor’s conducting BA/BE studies, common outsourced activities are clinical activities (80%), sample analysis (75%), results reporting (65%), data and statistical analysis (75%), quality assurance (45%), study design (55%), and site monitoring (45%).
*:Prospects of Conducting Bioavailability/Bioequivalence (BA/BE) Studies and Outsourcing in Semi-Regulated Countries (page 16 ‑ 19).
Selection of a CRO is a critical component for a successful trial. ARIANNE conducts clinical trials including Bioavailability/Bioequivalence studies in Emerging Economies including MENA and S. Africa. Our local staff is well versed in their country requirements and fluent in the native languages as well as English. ARIANNE has a strong international regulatory understanding, and a corporate commitment to develop long-term relationships with a strong team approach to assist your global needs. Visit us at www.ariannecorp.com.