Conduct Quality Bioavailability Studies with Lotus Labs
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 Bioavailability studies from all the 4 locations spread over two major cities of India like Bangalore (3) and Chennai (1).
Bioavailability (BA) is defined as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
Measuring the bioavailability becomes an important tool to evaluate the new formulation developed by the pharmaceutical company. Lotus Labs Pvt Ltd. conducts Bioavailability studies to provide other useful pharmacokinetic information related to distribution, elimination, the effects of nutrients on absorption of the drug, dose proportionality, linearity in pharmacokinetics of the active moieties and, where appropriate, inactive moieties.
Expertise in Bioavailability Studies
Bioavailability data can also provide information indirectly about the properties of a drug substance before entry into the systemic circulation, such as permeability and the influence of pre-systemic enzymes and/or transporters (e.g., p-glycoprotein).Once the product is proved to have an adequate bioavailability then the same product can be chosen for bio equivalence to compare with the innovator drug from that particular regulatory. We have an extensive database to conduct the bio availability studies to enhance the confidence of the sponsor Pharma Companies. Apart from that we have a wide experience to conduct the bioavailability studies with highly technical staff ranging an average experience of 6 years and expertise in conducting studies with orals including IR and MR formulations, suspensions and other formulations.
Bioavailability for orally administered drug products can be documented by developing a systemic exposure profile. A profile can be obtained by measuring the concentration of active ingredients and/or active moieties and, when appropriate, its active metabolites over time in samples collected from the systemic circulation. Systemic exposure patterns reflect both release of the drug substance from the drug product and a series of possible pre-systemic/systemic actions on the drug substance after its release from the drug product.