Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Statistical problems in interpreting comparative bioavailability trials.

W J Westlake

    International Journal of Clinical Pharmacology and Biopharmacy
    |June 1, 1975
    PubMed
    Summary
    This summary is machine-generated.

    Related Concept Videos

    You might also read

    Related Articles

    Articles linked to this work by shared authors, journal, and citation graph.

    Sort by
    Same author

    Steady-state lithium blood level fluctuations in man following administration of a lithium carbonate conventional and controlled-release dosage form.

    Journal of clinical pharmacology·1981
    Same author

    The bladderless dog: a new animal model for use in experimental xenobiology.

    Drug metabolism reviews·1981
    Same author

    Statistical aspects of comparative bioavailability trials.

    Biometrics·1979
    Same author

    Bioavailability of cimetidine in man.

    Gastroenterology·1978
    Same author

    Symmetrical confidence intervals for bioequivalence trials.

    Biometrics·1976
    Same author

    Statistical implications in generic equivalents.

    Psychopharmacology bulletin·1976
    Same journal

    Effect of systemic autonomic inhibition on the hemodynamic response to antihypertensive therapy with timolol.

    International journal of clinical pharmacology and biopharmacy·1979
    Same journal

    Treatment of hyperlipoproteinemia (HLP) type II A with a new phenoxy-isobuturic acid derivative, procetofen.

    International journal of clinical pharmacology and biopharmacy·1979
    Same journal

    Treatment of hyperlipoproteinemia type II with etofibrate.

    International journal of clinical pharmacology and biopharmacy·1979
    Same journal

    In vitro and in vivo characteristics of some commercial phenobarbital tablets.

    International journal of clinical pharmacology and biopharmacy·1979
    Same journal

    Pharmacokinetics of naproxen in healthy volunteers and in patients with diabetic microangiopathy.

    International journal of clinical pharmacology and biopharmacy·1979
    Same journal

    Appropriate nitroxoline dosage regimen design.

    International journal of clinical pharmacology and biopharmacy·1979
    See all related articles

    Comparative bioavailability studies assess drug formulation equivalence. Statistical analysis using confidence intervals, focusing on therapeutic relevance, is recommended over traditional hypothesis-testing for in vivo drug behavior.

    Area of Science:

    • Pharmacokinetics
    • Drug Development
    • Biostatistics

    Background:

    • Comparative bioavailability studies are crucial for drug formulation equivalence.
    • Statistical analysis of drug concentrations in blood/urine is key.
    • Current methods face challenges in selecting appropriate analyses and statistical approaches.

    Purpose of the Study:

    • To evaluate the equivalence of a new drug formulation against a standard.
    • To critically assess the statistical methods used in comparative bioavailability.
    • To propose improvements in the analysis of in vivo drug behavior data.

    Main Methods:

    • Analysis of drug concentrations in biological fluids (blood/urine).
    • Critique of traditional hypothesis-testing in bioavailability assessments.

    Related Experiment Videos

  • Proposal for using confidence intervals for statistical analysis.

    • Main Results:

    • Hypothesis-testing is often irrelevant for determining drug equivalence.
    • Confidence intervals offer a more appropriate statistical approach.
    • Analysis should prioritize drug characteristics relevant to therapeutic use.

    Conclusions:

    • Shift from hypothesis-testing to confidence intervals in bioavailability analysis.
    • Focus statistical analysis on clinically meaningful drug parameters.
    • Ensures more relevant and accurate assessment of drug formulation equivalence.