A Regulatory Perspective on Pharmacokinetic/Pharmacodynamic Modelling

June 1999 in “ Statistical Methods in Medical Research ”

Stella G. Machado, Raymond Miller, Chengcheng Hu

pharmacokinetic modeling pharmacodynamic modeling tamsulosin benign prostatic hypertrophy piroxicam minoxidil NONMEM software BPH Rogaine

From the encyclopedia

tamsulosin →

Minoxidil →

An essential vasodilator with some anti-androgenic effects

Studysummary This paper reviews the role of pharmacokinetic/pharmacodynamic modeling in drug development, emphasizing its application for drug dosing guidance, safety resolution, and therapeutic monitoring improvement, without presenting new clinical results.

Automatically generated from the study's abstract, not written by a person, and not a review of the full paper. Not medical advice or a treatment recommendation. Read the original study, and consult a qualified healthcare professional before changing treatment. Full disclaimer ·

View this study on journals.sagepub.com →

Discuss this study in the Community →

Similar Research

5 / 1000+ results

Simultaneous Target-Mediated Drug Disposition-Pharmacodynamic Modeling of Finasteride and Dutasteride: Impact of Target Binding and Turnover on Non-Linear Pharmacokinetics

research Simultaneous Target-Mediated Drug Disposition-Pharmacodynamic (TMDD-PD) Modeling of Finasteride and Dutasteride: Impact of Target Binding and Turnover on Non-linear Pharmacokinetics

December 2025 in “The AAPS Journal”

Finasteride and dutasteride's effects are mainly due to target binding saturation and slow enzyme turnover.

research Pharmacodynamic modeling of finasteride, a 5 alpha-reductase inhibitor.

7 citations , July 1995 in “PubMed”

Finasteride, a drug that changes testosterone to a different hormone, was studied and its effects over time were modeled successfully.

Pharmacokinetic Interaction of Finasteride With Tamsulosin Hydrochloride: An Open-Label, Randomized, Three-Period Crossover Study in Healthy Chinese Male Volunteers

research Pharmacokinetic Interaction of Finasteride With Tamsulosin Hydrochloride: An Open-label, Randomized, 3-period Crossover Study in Healthy Chinese Male Volunteers

7 citations , November 2014 in “Clinical Therapeutics”

This study observed that coadministration of finasteride and tamsulosin in healthy Chinese males appears unlikely to result in a clinically significant pharmacokinetic interaction.

research Evaluating the safety profile of α-1 blockers, 5α-reductase inhibitors, and PDE5I for BPH: a disproportionality analysis of real-world adverse events based on FDA adverse event reporting system (FAERS)

March 2026 in “Figshare”

This study analyzed the FDA Adverse Event Reporting System and found distinct safety signals and adverse event patterns among α1-blockers, 5α-reductase inhibitors, and tadalafil used in treating benign prostatic hyperplasia, emphasizing known risks and identifying potential new ones that require further study.

Tamsulosin Treatment for Benign Prostatic Hyperplasia and Risk of Severe Hypotension in Men Aged 40-85 Years in the United States: Risk Window Analyses Using Between and Within Patient Methodology

research Tamsulosin treatment for benign prostatic hyperplasia and risk of severe hypotension in men aged 40-85 years in the United States: risk window analyses using between and within patient methodology

70 citations , November 2013 in “The BMJ”

This study observed a temporal association between tamsulosin use for benign prostatic hyperplasia and an increased risk of severe hypotension requiring hospital admission during the first eight weeks of treatment initiation and restart.