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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.

research Bioequivalence study of generic finasteride in healthy male volunteers.

2 citations , September 2011 in “Chiang Mai Medical Journal - เชียงใหม่เวชสาร”

This study demonstrated that the 5-mg generic finasteride tablet is bioequivalent to the original tablet when tested in healthy Thai male volunteers.

research Pharmacokinetics and Bioequivalence of Finasteride Tablets in Healthy Subjects

1 citations , January 2003 in “Zhongguo yaoke daxue xuebao”

This study determined that finasteride test and reference tablets are bioequivalent in human participants, as no significant differences were found in their pharmacokinetic parameters.

research Bioequivalent Assessment of Finasteride Granules in Chinese Healthy Volunteers

January 2009 in “Chinese Journal of Drug Application and Monitoring”

This study concluded that finasteride granules are bioequivalent to finasteride tablets based on pharmacokinetic evaluation in healthy male volunteers.

research Bioequivalent assessment of finasteride tablets

January 2005 in “Chinese New Drugs Journal”

This study concluded that locally manufactured finasteride tablets are bioequivalent to imported ones based on pharmacokinetic profiles in male volunteers.

research Bioequivalence Study of Finasteride Tablets in Human Plasma by HPLC-MS

January 2012 in “Pharmacy Today”

This study concluded that two formulations of finasteride were bioequivalent based on Cmax, AUC, and Tmax data from healthy volunteers.

research Bioequivalence of finasteride tablet in healthy volunteers by LC-MS/MS

January 2010 in “Chinese Journal of Hospital Pharmacy”

This study found that finasteride test and reference tablets are bioequivalent in healthy male volunteers, with no significant differences in their pharmacokinetic parameters.

research Study on Bioequivalence of Finasteride Tablets in Human Body

January 2005 in “Zhongguo yaofang”

This study found that domestic and imported finasteride tablets were bioequivalent in terms of their pharmacokinetic parameters and relative bioavailability in human volunteers.

research Bioequivalence of finasteride tablets in healthy volunteers

January 2005 in “Zhōnghuá yàoxué zázhì”

This study concluded that two different finasteride tablet formulations are bioequivalent based on their pharmacokinetic profiles in a crossover trial with male subjects.

research Determination of Finasteride in Human Plasma by HPLC-MS and Study on the Bioequivalence of Domestic and Import Finasteride Tablets

January 2005 in “Yaowu fenxi zazhi”

This study concluded that domestic and imported finasteride tablets are bioequivalent, with no significant differences in their pharmacokinetics among healthy volunteers.

research Bioequivalence of two kinds of finasterides tablets in healthy volunteers

January 2004 in “Chinese Journal of New Drugs and Clinical Remedies”

This study concluded that two different brands of finasteride tablets are bioequivalent based on their pharmacokinetic parameters and relative bioavailability.

research Bioequivalance of single oral administration of finasteride tablet and capsule in healthy volunteers

January 2004

This study found that the finasteride tablet and capsule are bioequivalent to the control finasteride tablet in healthy volunteers.

research Studies on the pharmacokinetics and bioquivalence of domestic finasteride tablet in healthy volunteers

January 2004

This study concluded that domestic and imported finasteride tablets are bioequivalent, showing no significant differences in pharmacokinetic parameters among healthy volunteers.

research Bioequivalence Study of Finasteride Tablets in Healthy Volunteers

January 2003 in “The Chinese Journal of Clinical Pharmacology”

In this study, the authors concluded that the tested and reference finasteride tablets showed bioequivalence in healthy male volunteers.

research Clinical Considerations of Bioequivalence for Topical Dermatologic Drugs

1 citations , January 2014

This review discusses various methods to assess bioequivalence between dermatologic drugs and highlights the potential of visual inspection and percutaneous penetration research.

research Bioequivalence of Procare Tablet to Proscar^®Tablet (Finasteride 5 mg)

April 2006 in “Journal of Korean Pharmaceutical Sciences”

research Study on Human Bioequivalency of Two Preparations of Finasteride

January 2005 in “Journal of Elinical Research”

This study found that the pharmacokinetic profile of finasteride capsules and tablets in healthy volunteers is bioequivalent.

research P-215 Study on Bioequivalence of Finasteride Tablet in Healthy Volunteers

September 2005 in “日本医療薬学会年会講演要旨集”

Formulation of a Film-Coated Dutasteride Tablet Bioequivalent to a Soft Gelatin Capsule (Avodart): Effect of Gamma-Cyclodextrin and Solubilizers

research Formulation of a film-coated dutasteride tablet bioequivalent to a soft gelatin capsule (Avodart®): Effect of γ-cyclodextrin and solubilizers

4 citations , May 2019 in “Asian Journal of Pharmaceutical Sciences”

This study found that a dutasteride tablet formulation using cyclodextrin complex, solubilizing polymer, and surfactant achieved similar bioavailability in beagle dogs to that of a commercial capsule.

research Experimental models to investigate the efficacy and bioequivalence of low dose topical corticoids

March 2004 in “Journal of The American Academy of Dermatology”

This study found that the vehicle of hydrocortisone impacts its absorption and therapeutic effectiveness, as demonstrated by efficacy tests using UV-erythema and vasoconstriction models.

research Determination of Finasteride in Human Plasma by LC-MS and Study on its Bioequivalent

January 2007 in “Pharmaceutical Journal of Chinese People's Liberation Army”

In this study, the researchers found that two formulations of finasteride tablets were bioequivalent in Chinese healthy male volunteers.

research Cyberspace Chat: An Examination of Brand-Name vs Generic Finasteride: A look at Active Pharmaceutical Ingredient (API), Excipients, Bioequivalence, and Other Factors Affecting Efficacy

1 citations , January 2016 in “Hair transplant forum international”

This article compiles internet forum posts discussing differences between brand-name and generic finasteride pills, but it presents no new clinical findings.

Original Research—Endocrinology: Comparison of the Steady-State Pharmacokinetics, Metabolism, and Variability of a Transdermal Testosterone Patch Versus a Transdermal Testosterone Gel in Hypogonadal Men

research ORIGINAL RESEARCH—ENDOCRINOLOGY: Comparison of the Steady‐State Pharmacokinetics, Metabolism, and Variability of a Transdermal Testosterone Patch Versus a Transdermal Testosterone Gel in Hypogonadal Men

38 citations , February 2005 in “The journal of sexual medicine”

This study found that a testosterone patch and gel showed bioequivalent testosterone levels in hypogonadal men, but the patch mimicked a natural circadian profile, while the gel resulted in higher dihydrotestosterone levels.

research Pharmacokinetics of a new testosterone transdermal delivery system, TDS^®‐testosterone in healthy males

33 citations , December 2005 in “British Journal of Clinical Pharmacology”

This study found that the Transdermal Delivery System efficiently delivers testosterone systemically and showed bioequivalent hormone concentrations to a known topical gel in healthy males.

research [Determination of finasteride in human plasma by HPLC-MS].

2 citations , June 2003 in “PubMed”

The two finasteride formulations are bioequivalent.

Finasteride Quantification in Human Plasma by High-Performance Liquid Chromatography Coupled to Electrospray Ionization Tandem Mass Spectrometry: Application to a Comparative Pharmacokinetics Study

research Finasteride Quantification in Human Plasma by High-Performance Liquid Chromatography Coupled to Electrospray Ionization Tandem Mass Spectrometry. Application to a Comparative Pharmacokinetics Study

1 citations , April 2015 in “Drug research”

This study concluded that two different pharmaceutical formulations of finasteride were bioequivalent in terms of rate and extent of absorption based on pharmacokinetic evaluations in a randomized crossover study with 38 volunteers.