Bioavailability / Bioequivalence

Bioavailability / Bioequivalence Services

Our team is specialized in conducting bioavailability / bioequivalence studies, offering a comprehensive range of services that help pharmaceutical, biotechnology and generic drug companies optimize their formulations and meet regulatory requirements. Our expertise ensures study designs meet safety, efficacy, regulatory standards and accelerating the path to market.

GenBiosis conduct bioavailability / bioequivalence studies as follows:

Fasting, Fed and Food – effect studies
Parallel, Crossover, Partial Replicate and Full Replicate
Long housing studies
Long duration studies with ambulatory sampling
Proof-of-concept studies
Special population studies
Multiple dose studies
Phase I studies

Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of generic version to its proprietary version of a drug or formulations of innovator drug in different clinical trial phases.

GenBiosis Labs has an experienced clinical team comprising trained and experienced physicians, pharmacologists, pharmacists, science post-graduates and graduates with extensive experience in clinical research. Our services include clinical conduct, monitoring, bio-analysis, project management, medical writing and statistical support as per regulatory requirements.

Injection

Intramuscular, intravenous, subcutaneous

Tablets

Immediate release, extended release, sustained release, modified release, delayed release, ODT, chewable

Capsules

Extended release, modified release, delayed release, soft gelatin

Suspension, Solutions, Granules

Oral suspension, oral solution, reconstitutable granules

Sublingual

Sublingual tablets, fast-dissolving tablets, rapid melt strips

Bioanalytical

Expertise & Capabilities:

Expert knowledge and experience in conducting bioanalytical assays for unstable compounds, compounds having metabolite back-conversion, endogenous compounds, chiral compounds, etc.
Dedicated teams ensure that all work is conducted in compliance with SOPs and all applicable regulatory guidelines.
A highly experienced team involved in method development and method validation of simple to complex assays employing the most sensitive LC-MS/MS.
Have the capabilities to conduct extensive literature searches for difficult assays.
Meticulous method development strategies with experiments covering precision, accuracy, and all important stability studies.
Our state-of-the-art BA laboratories offer bioanalytical testing using methods such as LC-MS/MS (Liquid Chromatography-Mass Spectrometry) to accurately measure drug concentrations in biological samples, providing precise data for BA/BE studies.

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Services

Bioavailability

Clinical Trial Services

Medical Writing Services

Regulatory Services

Contact

info@gen-biosis.com

Corporate office and BA/BE Centre, Majestic Plaza, Sr. No. 21/5, Near Manipal Hospital, Kharadi, Pune – 411 014, Maharashtra.