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Glossary Bioequivalence

...similarity in drug absorption and effect between two formulations

Bioequivalence refers to the relationship between two drugs that have the same active ingredients and are expected to have the same effect on the body. For two drugs to be considered bioequivalent, they must show similar bioavailability, meaning they release their active ingredients into the bloodstream at the same rate and extent. This concept is crucial for approving generic drugs, ensuring they perform just as effectively as their brand-name counterparts.

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Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model

research Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model

15 citations , January 2024 in “The AAPS Journal”

This study demonstrates that bioequivalence for proposed 50-mg ritlecitinib capsules versus clinical 100-mg capsules can be supported using a PBPK model-based biowaiver, achieving over 90% probability of success.

Bioequivalence of a Single 10-mg Dose of Finasteride 5-mg Oral Disintegrating Tablets and Standard Tablets in Healthy Adult Male Han Chinese Volunteers: A Randomized Sequence, Open-Label, Two-Way Crossover Study

research Bioequivalence of a single 10-mg dose of finasteride 5-mg oral disintegrating tablets and standard tablets in healthy adult male Han Chinese volunteers: A randomized sequence, open-label, two-way crossover study

10 citations , October 2009 in “Clinical Therapeutics”

This study found that the orally disintegrating tablet and standard tablet formulations of finasteride met bioequivalence criteria in fasting healthy adult male Han Chinese volunteers, although there was a significant difference in time to maximum concentration.

research Bioequivalence Study of Finasteride

6 citations , December 2011 in “Drug Research”

This study concluded that Flaxin tablets and the reference formulation are bioequivalent in terms of absorption rate and extent when administered as a single 5 mg dose to healthy male volunteers.

research Bioequivalence Study of Two Different Coated Tablet Formulations of Finasteride in Healthy Volunteers

4 citations , December 2011 in “Drug Research”

This study found that two different 5 mg finasteride tablet formulations are bioequivalent in terms of the rate and extent of absorption in healthy volunteers.

Evaluation of Bioequivalence of Five 0.1 mg Dutasteride Capsules Compared to One 0.5 mg Dutasteride Capsule: A Randomized Study in Healthy Male Volunteers

research Evaluation of bioequivalence of five 0.1 mg dutasteride capsules compared to one 0.5 mg dutasteride capsule: a randomized study in healthy male volunteers

3 citations , January 2015 in “Journal of drug assessment”

This study found that five 0.1 mg dutasteride capsules are bioequivalent to one 0.5 mg dutasteride capsule in healthy adult males under fasting conditions, and both were well tolerated.

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