Expertise in Bioequivalence Studies
In the past 11 years history of Lotus Labs Pvt Ltd. we have gained a significant experience to encourage our sponsor by helping them out to conduct a quality Bioequivalence studies from all the 4 locations spread over two major cities of India like Bangalore (3) and Chennai (1).
Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
As noted in the statutory definitions, both Bioequivalence and product quality Bioavailability focus on the release of a drug substance from a drug product and subsequent absorption into the systemic circulation. Bioavailability is a benchmarking effort with comparisons to an oral solution, oral suspension, or an intravenous formulation. In contrast, demonstrating Bioequivalence is usually a more formal comparative test that uses specified criteria for comparisons and predetermined Bioequivalence limits for such criteria.
At Lotus Labs Pvt. Ltd. we conduct various studies on bioequivalence (BE) and pharmacokinetics in strict compliance with international regulatory requirements. The Bioequivalence studies are meticulously monitored by an independent Quality Assurance department. Our expertise in Bioequivalence studies has ensured the development of over 290 validated bio-analytical methods to analyze over 35,000 samples per month and constituted a dedicated team which is competent to develop and validate a minimum of 5 methods for Bioequivalence studies every month.
At Lotus Labs Pvt. Ltd., the experience in Bioequivalence studies addresses various formulations including Solid oral formulation (IR, ER, MR and dispersible tablets) and liquid oral formulations like syrups and suspensions. Lotus Labs, also, has considerable experience in various dosage forms including injectables like IM/IV and Subcutaneous (SC), topical preparation and nasal sprays.