Therapeutic Equivalency

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  Subject Areas on Research

  • A Systematic Literature Review Approach to Estimate the Therapeutic Index of Selected Immunosuppressant Drugs After Renal Transplantation. 
  • A comparison of FDA and EMA drug approval: implications for drug development and cost of care. 
  • A comparison of moment-based and probability-based criteria for assessment of follow-on biologics. 
  • A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. 
  • A multivariate test for population bioequivalence. 
  • A note on sample size calculation for mean comparisons based on noncentral t-statistics. 
  • A note on sample size determination for bioequivalence studies with high-order crossover designs. 
  • A note on statistical methods for assessing therapeutic equivalence. 
  • A perspective on the regulation of the evaluation of new antithrombotic drugs. 
  • A practical approach for comparing means of two groups without equal variance assumption. 
  • A small sample confidence interval approach to assess individual bioequivalence. 
  • A two one-sided tests procedure for assessment of individual bioequivalence. 
  • ACCF/AHA 2011 health policy statement on therapeutic interchange and substitution: a report of the American College of Cardiology Foundation Clinical Quality Committee. 
  • Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: A randomized equivalence trial. 
  • Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. 
  • An adjusted two one-sided t-test for the assessment of bioequivalence with multiple doses. 
  • An individual bioequivalence approach to compare the intrasubject variability of two ciclosporin formulations, SangCya and Neoral. 
  • An individual bioequivalence criterion: regulatory considerations. 
  • Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials. 
  • Antisense oligodeoxynucleotides prevent acute cardiac allograft rejection via a novel, nontoxic, highly efficient transfection method. 
  • Application of an LC-MS/MS method for reliable determination of amodiaquine, N-desethylamodiaquine, artesunate and dihydroartemisinin in human plasma for a bioequivalence study in healthy Indian subjects. 
  • Applications of the bayesian prior information to evaluation of equivalence of similar biological medicinal products. 
  • Assessing bioequivalence and drug interchangeability. 
  • Assessing bioequivalence using genomic data. 
  • Assessing biosimilarity and interchangeability of biosimilar products. 
  • Assessing sensitivity and similarity in bridging studies. 
  • Assessment of bioequivalence using a multiplicative model. 
  • Association of diabetes mellitus and glycemic control strategies with clinical outcomes after acute coronary syndromes. 
  • Bioequivalence assessment of zidovudine (Retrovir) syrup, solution, and capsule formulations in patients infected with human immunodeficiency virus. 
  • Bioequivalence of two tablet formulations of nadolol using single and multiple dose data: assessment using stereospecific and nonstereospecific assays. 
  • Bioequivalence review for drug interchangeability. 
  • Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children. 
  • Clinical and therapeutic profile of patients presenting with acute coronary syndromes who do not have significant coronary artery disease.The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) Trial Investigators. 
  • Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs. 
  • Double-blind randomized study comparing brand-name and generic phenytoin monotherapy. 
  • Efficacy and toxicity of a CCNU-containing high-dose chemotherapy regimen followed by autologous hematopoietic cell transplantation in relapsed or refractory Hodgkin's disease. 
  • Emerging evidence concerning systemic safety of anti-VEGF agents--should ophthalmologists be concerned? 
  • Equivalence Ratio for Daunorubicin to Doxorubicin in Relation to Late Heart Failure in Survivors of Childhood Cancer. 
  • Evaluation of a scaling approach for the bioequivalence of highly variable drugs. 
  • Examining outlying subjects and outlying records in bioequivalence trials. 
  • Frequency estimator for assessing of follow-on biologics. 
  • Generic and branded drugs for the treatment of people living with HIV/AIDS. 
  • Generic clopidogrel: time to substitute? 
  • Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report. 
  • Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report. 
  • How much radiation is the chemotherapy worth in advanced head and neck cancer? 
  • Human test models for bioequivalence of topical corticosteroids: a review. 
  • Immune globulin subcutaneous, human - klhw 20% for primary humoral immunodeficiency: an open-label, Phase III study. 
  • Improving drug prescribing in a primary care practice. 
  • In vitro bioequivalence testing. 
  • Individual bioequivalence testing under 2x3 designs. 
  • Initial platelet activity may predict efficacy after chronic oral glycoprotein IIb/IIIa blockade: should we still consider uniform treatment regimens? 
  • Management of cancer pain. 
  • Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence. FDA Individual Bioequivalence Working Group. 
  • Meta-analysis for bioequivalence review. 
  • Mini test dose of intravenous busulfan (busulfex(®)) in allogeneic non-myeloablative stem cell transplantation, followed by liquid chromatography tandem-mass spectrometry. 
  • Nonparametric tests for evaluation of biosimilarity in variability of follow-on biologics. 
  • On Bayesian Analysis and Hypothesis Testing in the Determination of Bioequivalence. 
  • On assessing bioequivalence and interchangeability between generics based on indirect comparisons. 
  • On assessing bioequivalence using genomic data with model misspecification. 
  • On assessment of bioequivalence under a higher-order crossover design. 
  • On safety margin for drug interchangeability. 
  • On sample size calculation in bioequivalence trials. 
  • On sample size requirement for analytical similarity assessment. 
  • On statistical power for average bioequivalence testing under replicated crossover designs. 
  • Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects. 
  • Pharmacokinetics and bioequivalence of a combined oral formulation of eniluracil, an inactivator of dihydropyrimidine dehydrogenase, and 5-fluorouracil in patients with advanced solid malignancies. 
  • Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia. 
  • Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%). 
  • Pharmacokinetics of amlodipine and olmesartan after administration of amlodipine besylate and olmesartan medoxomil in separate dosage forms and as a fixed-dose combination. 
  • Preface. Bioequilavence measures. 
  • Ranibizumab and bevacizumab for neovascular age-related macular degeneration. 
  • Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future. 
  • Resolving paradoxes in acupuncture research: a roundtable discussion. 
  • Sample size calculation in bioequivalence trials. 
  • Sample size determination for the two one-sided tests procedure in bioequivalence. 
  • Some thoughts on drug interchangeability. 
  • Some thoughts on individual bioequivalence. 
  • Statistical and regulatory considerations in assessments of interchangeability of biological drug products. 
  • Statistical assessment of biosimilar products. 
  • Statistical evaluation of the scaled criterion for drug interchangeability. 
  • Statistical methods for assessment of biosimilarity using biomarker data. 
  • Statistical test for evaluation of biosimilarity in variability of follow-on biologics. 
  • Subject-by-formulation interaction in bioequivalence: conceptual and statistical issues. FDA Population/Individual Bioequivalence Working Group. Food and Drug Administration. 
  • The bootstrap procedure in individual bioequivalence. 
  • The effect of formulation and food consumption on the bioavailability of dovitinib (TKI258) in patients with advanced solid tumors. 
  • The impact of outlying subjects on decision of bioequivalence. 
  • The price of psychotropic drugs: a neglected factor. 
  • The roles of patents and research and development incentives in biopharmaceutical innovation. 
  • Thrombolytic therapy for myocardial infarction. 
  • Topical oxygen is not hyperbaric oxygen (HBO2). 
  • Treatment of steroid-refractory acute graft-versus-host disease with anti-CD147 monoclonal antibody ABX-CBL. 
  • Understanding therapeutic equivalence in epilepsy. 
  • Using Medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities.