Bioavailability/Bioequivalence Detection

Bioavailability refers to the extent and rate at which the active pharmaceutical ingredients or active parts of the drugs are absorbed and available at the site of action of the drug action. It is an indicator reflecting the degree and speed of absorption of the active ingredient into the body and has become an important means to evaluate the quality of preparations. It is generally divided into absolute bioavailability and relative bioavailability. Absolute bioavailability refers to the relative amount of the active ingredient of the drug absorbed into the body circulation obtained by intravenous preparations (usually considered as 100% ) as the reference preparations; relative bioavailability refers to the relative amount of active ingredients absorbed into the systemic circulation by preparations administered by other nonintravenous routes (such as tablets and oral solutions). If the bioavailability of two drug products is similar, the drug products are called bioequivalent.

CD Formulation laboratory is cGMP-compliant and equipped with state of the art analytical instruments. We have experienced analysis experts who can work with our formulation and manufacturing team to provide you with bioavailability/ bioequivalence detection services. Our scientists develop and utilize robust bioanalytical methods for evaluating the bioavailability/bioequivalence of your drugs, and our data is accurate and reproducibility, which can help you to conduct an appropriate risk assessment of the finished drug.

Our Methods of Bioavailability/Bioequivalence Detection

The research method with pharmacokinetic parameters as the endpoint is the commonly used bioequivalence research method. A complete bioequivalence study includes biological sample analysis, experimental design, statistical analysis and result evaluation.

• Pharmacokinetic studies
• Clinical comparison trial
• In vitro studies

Methods of Biological Sample Analysis

Deliverable

• Data analysis
• Provide full study report

Our Advantages

If you have a requirement about bioavailability/ bioequivalence detection services, please contact us by phone or email, our colleagues will reply to you within three working days. content uniformity test

References

1. Chow S C. Bioavailability and Bioequivalence in Drug Development[J]. Wiley Interdisciplinary Reviews: Computational Statistics, 2014, 6(4): 304-312.
2. Shah V P, Midha K K, Dighe S, et al. Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies[J]. Journal of Pharmaceutical Sciences, 1992, 81(3): 309-312.