An Overview of Bioavailability Studies
The best way to define Bioavailability studies is that it is kind of study that defines “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”
Reasons for studying bio-availability
There are numerous reasons for bioavailability studies. The study can:-
* Offers realistic data on potential health effects of contamination
* Assists in prioritizing sites for subsequent evaluation
* Changes proposed clean-up levels saving money and time to reach acceptable levels
* Modifies defaults making use of specific information
Eminent CRO’s (Clinical Research Organization) follows numerous procedures to evaluate bioavailability. Some of them are as follows:-
* Extraction using acids and bases
* Extraction using biological fluids
* Statistical estimation methods
* Site specific analysis that offers essential data that can influence a risk assessment
Estimating bioavailability has become an essential tool to estimate the new formulations that are developed by the pharmaceutical enterprises. Esteemed CRO’s in India carries on Bioavailability studies and other clinical trials to offer other essential Clinical Pharmacokinetic data associated with elimination, distribution, the impact of nutrients and where apt, passive moieties. Furthermore, bioavailability information can offer data indirectly about the properties of a drug substance before entering into systematic circulation, as impact and permeability of pre-systemic enzymes as well as transporters, for instance p-glycoprotein. As soon as the product is offered to have a sufficient bioavailability then the same product is chosen for bio equivalence to compare with the drug from a certain regulatory.
Esteemed CRO’s in India offers an extensive database for conducting clinical trials as well as bioavailability studies to improve the confidence level of the sponsor pharmaceutical enterprise. These CRO’s have extensive experience to perform bioavailability studies with an advanced technical medical staff. CRO’s have the experience in conducting studies with oral dosage form that includes MR and IR formulations, suspensions and other formulations.
Bioavailability for orally monitored drug products can be documented by setting up a systemic exposure profile. This profile can be attained by evaluating the mix of active ingredients or active fractions when apt. The systemic exposure patterns indicate both the release of drug substance from the drug product and a series of possible pre-systemic or systemic actions on the drug substance post its release from the drug specimen.
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