Bioavailability and Bioequivalence

Studies to measure bioequivalence (BE) and bioavailability (BA) of a product are important elements in support of lead optimization and IND-enabling. Creative Biolabs offers BA/BE services through our full-fledged, state-of-the-art PK studies.

Bioavailability (BA) is the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action. It estimates the fraction of the drug absorbed. Bioequivalence (BE) is the relationship between two proprietary preparations of the same drug in the same dosage form that have a similar bioavailability. We measure several PK parameters and estimate the BA and BE of a drug for our customers.

Creative Biolabs offers BA/BE data for the following substances:

• New chemical entities
• New formulations of active substances
• New dosage forms of a registered drug
• Variations of a marketed product: change of main excipients or manufacturing process, change of salt or ester, line extension, etc.
• The administration in another population, i.e. children
• The acceptance of wider than standard side batch ranges

Bioavailability

Bioavailability is defined as the fraction (percentage) of an administered dose of unchanged medicine that reaches the bloodstream (systemic circulation). To achieve a therapeutic effect, the active pharmaceutical ingredient (API) needs to enter the body and reach correct dose at the target site. Besides, API needs to reach the target site within a certain time and be available there for a defined time.

Creative Biolabs provides several in vivo and in vitro methods to measure BA, which include:

• Fasting studies
• Fed/food-effect studies
• Single-dose studies and multiple-dose studies
• Measurement of metabolite
• Drug-drug interaction PK studies
• PD studies

We evaluate several characteristics in plasma, whole blood or urine for BA, which include:

• Normal primary parameters: AUC_t, AUC_inf, C_max, T_max, A_et, Ae_inf
• Also recommended: t_½, MRT and in steady-state studies: AUC_tau, C_max, C_min, fluctuation index

Bioequivalence

When giving an intravenous injection (IV) directly into the bloodstream, the bioavailability is defined as 100%. For a particular drug formulation, we provide an estimation of the relative fraction dose that is absorbed into the systemic circulation. For instance, for orally administered drug products, BA/BE can be documented by comparing a systemic exposure profile to that of IV.

We are able to study the BA/BE with dosage forms including immediate release (IR), controlled release (CR) modified release (MR), extended release (ER), solid oral, oral dispersible tablets (ODT), parenteral formulations, sublingual, injections, gels, dry powder, sprays, and suspensions.

Bioanalytical Services

We offer comprehensive bio-analytical services for several sample matrices (such as blood, serum, plasma and urine). Our state-of-the-art infrastructure is spread over 2,000 sq. ft. and is equipped a sample processing area with cutting edge capabilities. It enables simultaneous conduction of multiple studies in quick turnaround time. Our fully GLP-compliant bioanalytical lab offers LC-MS/MS and HPLC instruments for the estimation of drugs and metabolites.

Our bioanalytical support services include:

• Project management
• Study design
• Protocol writing
• Report writing
• Quality control and quality assurance
• Regulatory affairs (CTA)

For more detailed information, please feel free to contact us or directly sent us an inquiry.

For Research Use Only.