What is a Bioequivalence Study?
A bioequivalence study is a clinical trial that seeks to compare a medication produced by two different companies. One of the two medications is usually already being sold commercially, whereas the other is not. What is a Phase 1 Study? Once a drug compound has gone through preclinical testing, it is then ready to be administered in human beings. This testing is usually conducted in a small group (20 to 100) of healthy volunteers. The main objective of this type of study is to determine the safe dosage range at which a drug can be administered, the method of absorption and the elimination of the drug by the human body. How is a Study Designed? Once data is made available from our clients, our professional protocol writers, alongside our medical team, evaluate the needs and requests put forward by our clients. Once this data has been evaluated, our team of experts puts together a protocol indicating how the study will be conducted, which is then submitted to an independent review commit
Related Questions
- What indicates the period effect and sequence effect in a typical 2-way crossover bioequivalence study with a proper washout period?
- Why randomization is required for a typical Bioequivalence study (open label, cross over, balanced study)?
- Can the IP’s shipped to the CRO before the IRB approval for a typical Bioequivalence study ?
