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Bioavailability and Bioequivalence Studies

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.

Host factors that regulate drug bioavailability include intestinal anatomy, host genetics, and host metabolism.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

According to different research purposes, our experimental design can also be adjusted in the following aspects.
  • 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

  1. 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
All of our services are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.