Bioavailability (BA) refers to the degree and rate at which the administered drug is absorbed by the circulatory system, thereby accessing the sites of action. BA is one of the essential tools in drug development, since it must be considered when calculating dosages for non-intravenous routes of administration based on absorption. BA includes absolute bioavailability and relative bioavailability. Absolute bioavailability compares the bioavailability of the drugs in systemic circulation following non-intravenous administration and intravenous administration. Briefly, in absolute bioavailability, the standard is always intravenous administration. Relative bioavailability measures the bioavailability of a formulation of a certain medicine when compared with another formulation of the same medicine. Relative bioavailability is a measure used to assess bioequivalence between drug products. Bioequivalence (BE) is a study that compares the pharmacokinetic characteristics of a generic drug to that of the innovator. If the two products are considered to be bioequivalent, it means they are actually the same.
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Figure 1. The time-concentration curve for intravenous and oral routes.
Bioavailability and bioequivalence studies play an important role in the development of both new drugs and their generic equivalents. There are several approaches to assess BE, and each regulatory authority has its own regulations for conducting BA/BE research. At Creative Bioarray, our scientists fully understand the specifications and requirements of each regulatory authority and conduct your BA/BE investigations by employing rigorous laboratory practices and careful operating procedures.
Comprehensive BA/BE Solutions:
- Protocol design and development
- Trial operation and management
- Data management
- Pharmacokinetic study
- Bioanalysis
- Statistical analysis
- Report production
Compound Classes
- Small molecules
- Metabolites
- Lipids
- Peptides
Why Choose Bioavailability/Bioequivalence Tests from Creative Bioarray?
- A highly beneficial regulatory environment enable a fast study start within two to three weeks
- In-depth understanding of EC/CA requirements and specificities
- Bioanalytical laboratories for parallel samples dosing
- Highly experienced biostatistics and PK team to design studies and analyze data
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Creative Bioarray has conducted a number of BA/BE investigations, most frequently in dosing form optimization. We have validated methods for a wide range of compounds that can support your BA/BE investigations. Contact us today to discuss how we can help with your BA/BE trials.
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