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Bioavailability and Bioequivalence Studies
The bioavailability and bioequivalence of various compounds need to be evaluated during drug discovery. As a leading specialist in preclinical bioavailability and bioequivalence services, Alfa Cytology is committed to providing our clients with cost-effective, repeatable, high-quality data.
Introduction to Bioavailability
Bioavailability (BA) refers to the concentration of a drug compound that reaches the systemic circulation or site of action. For example, most oral drugs enter the general circulation through the gastrointestinal tract. BA is generally measured by assessing the drug's active pharmaceutical ingredients (API) concentration and metabolites in the plasma or serum. Compounds with low bioavailability may not reach therapeutic levels in the systemic circulation or require very high doses, which can be expensive or toxic. Assessing BA early in the drug discovery process can reduce attrition rates and guide subsequent drug development processes.
Fig. 1 Factors affecting drug bioavailability. (Bashiardes, S.; & Christodoulou, C., 2024)
Introduction to Bioequivalence
Bioequivalence (BE) studies are usually conducted between two drugs or drug preparations to compare their BA. In the appropriately designed research, if a similar BA is obtained after administering the test drug and the reference drug/formulation at the same molar dose under the same conditions, BE is indicated. Therefore, BE is an important component in demonstrating therapeutic equivalence and a prerequisite for approval of generic or new drug preparations.
Our Services
As a key drug absorption indicator, BA is determined by comparing pharmacokinetic (PK) measurements of a drug target in the systemic system after extravascular or intravenous administration. Alfa Cytology provides professional testing services to help clients determine the bioavailability and bioequivalence of drugs. Indicators used to assess drug bioavailability include the maximum concentration of the drug in circulation throughout the body (C max), the time to reach that concentration (T max), and the area under the time-drug concentration curve (AUC).
Bioavailability
BA is usually measured and compared in different groups according to the chosen method of administration. Alfa Cytology's standard procedure for studying BA in rat drug compounds is as follows.
Fasting at right
Different administration methods
Sampling at multiple time points
LC-MS/MS
PK parameter analysis
Bioequivalence
The preclinical bioequivalence test service between multiple therapies provided by Alfa Cytology means that each therapy is applied to an animal body in cross-study, usually healthy individuals, but occasionally pancreatic cancer models are also used.
The LC-MS/MS measures the concentration of the tested compounds in plasma to generate a concentration-time curve for each dosing group based on PK parameters and perform a BE assessment.
Other Services
- Number and species of animals
- Parallel non-crossover design
- Sample size calculation
- Drug dosing routes
- Customize sampling time point
- Higher-order crossover designs
- Fed/food effects
- Drug dosage
Why Choose Us?
Customized solution
Highly-experienced expert team
Variety of preclinical models
Quick turnaround time
Worldwide service
Alfa Cytology leverages skilled bioequivalence and bioavailability studies to advance your generic drug or new formulation development. Our scientists and laboratory analysts develop and utilize powerful bioanalytical methods to assess the bioavailability and bioequivalence of your drugs. We will be your best partner with high quality and fast turnaround service. Please contact us for more information about our services.
Reference
- Bashiardes, S.; & Christodoulou, C. Orally Administered Drugs and Their Complicated Relationship with Our Gastrointestinal Tract. Microorganisms 2024, 12, 242. https://doi.org/10.3390/microorganisms12020242
