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Subject Areas on Research
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A Systematic Literature Review Approach to Estimate the Therapeutic Index of Selected Immunosuppressant Drugs After Renal Transplantation.
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A comparison of moment-based and probability-based criteria for assessment of follow-on biologics.
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A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay.
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A note on sample size calculation for mean comparisons based on noncentral t-statistics.
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A note on sample size determination for bioequivalence studies with high-order crossover designs.
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A note on statistical methods for assessing therapeutic equivalence.
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A practical approach for comparing means of two groups without equal variance assumption.
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A two one-sided tests procedure for assessment of individual bioequivalence.
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ACCF/AHA 2011 health policy statement on therapeutic interchange and substitution: a report of the American College of Cardiology Foundation Clinical Quality Committee.
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Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema.
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An adjusted two one-sided t-test for the assessment of bioequivalence with multiple doses.
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Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials.
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Antisense oligodeoxynucleotides prevent acute cardiac allograft rejection via a novel, nontoxic, highly efficient transfection method.
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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.
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Applications of the bayesian prior information to evaluation of equivalence of similar biological medicinal products.
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Assessing bioequivalence and drug interchangeability.
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Assessing bioequivalence using genomic data.
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Assessing biosimilarity and interchangeability of biosimilar products.
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Assessing sensitivity and similarity in bridging studies.
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Assessment of bioequivalence using a multiplicative model.
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Association of diabetes mellitus and glycemic control strategies with clinical outcomes after acute coronary syndromes.
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Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial.
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Bioequivalence assessment of zidovudine (Retrovir) syrup, solution, and capsule formulations in patients infected with human immunodeficiency virus.
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Bioequivalence of two tablet formulations of nadolol using single and multiple dose data: assessment using stereospecific and nonstereospecific assays.
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Bioequivalence review for drug interchangeability.
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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.
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Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.
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Double-blind randomized study comparing brand-name and generic phenytoin monotherapy.
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Efficacy and toxicity of a CCNU-containing high-dose chemotherapy regimen followed by autologous hematopoietic cell transplantation in relapsed or refractory Hodgkin's disease.
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Equivalence Ratio for Daunorubicin to Doxorubicin in Relation to Late Heart Failure in Survivors of Childhood Cancer.
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Examining outlying subjects and outlying records in bioequivalence trials.
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Frequency estimator for assessing of follow-on biologics.
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Generic and branded drugs for the treatment of people living with HIV/AIDS.
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Generic clopidogrel: time to substitute?
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How much radiation is the chemotherapy worth in advanced head and neck cancer?
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Human test models for bioequivalence of topical corticosteroids: a review.
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Immune globulin subcutaneous, human - klhw 20% for primary humoral immunodeficiency: an open-label, Phase III study.
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Improving drug prescribing in a primary care practice.
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In vitro bioequivalence testing.
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Individual bioequivalence testing under 2x3 designs.
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Initial platelet activity may predict efficacy after chronic oral glycoprotein IIb/IIIa blockade: should we still consider uniform treatment regimens?
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Innovative Design and Analysis for PK/PD Biosimilar Bridging Studies with Multiple References.
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Meta-analysis for bioequivalence review.
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Mini test dose of intravenous busulfan (busulfex(®)) in allogeneic non-myeloablative stem cell transplantation, followed by liquid chromatography tandem-mass spectrometry.
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Nonparametric tests for evaluation of biosimilarity in variability of follow-on biologics.
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On Bayesian Analysis and Hypothesis Testing in the Determination of Bioequivalence.
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On assessing bioequivalence and interchangeability between generics based on indirect comparisons.
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On assessing bioequivalence using genomic data with model misspecification.
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On assessment of bioequivalence under a higher-order crossover design.
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On safety margin for drug interchangeability.
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On sample size calculation in bioequivalence trials.
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On sample size requirement for analytical similarity assessment.
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On statistical power for average bioequivalence testing under replicated crossover designs.
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Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects.
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Pharmacokinetics and bioequivalence of a combined oral formulation of eniluracil, an inactivator of dihydropyrimidine dehydrogenase, and 5-fluorouracil in patients with advanced solid malignancies.
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Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia.
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Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%).
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Preface. Bioequilavence measures.
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Ranibizumab and bevacizumab for neovascular age-related macular degeneration.
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Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.
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Sample size calculation in bioequivalence trials.
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Sample size determination for the two one-sided tests procedure in bioequivalence.
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Simultaneous confidence interval methods for analytical similarity assessment.
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Some thoughts on drug interchangeability.
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Some thoughts on individual bioequivalence.
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Statistical and regulatory considerations in assessments of interchangeability of biological drug products.
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Statistical assessment of biosimilar products.
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Statistical evaluation of the scaled criterion for drug interchangeability.
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Statistical methods for assessment of biosimilarity using biomarker data.
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Statistical test for evaluation of biosimilarity in variability of follow-on biologics.
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Stereoselective Steady-State Disposition and Bioequivalence of Brand and Generic Bupropion in Adults.
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The bootstrap procedure in individual bioequivalence.
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The effect of formulation and food consumption on the bioavailability of dovitinib (TKI258) in patients with advanced solid tumors.
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The impact of outlying subjects on decision of bioequivalence.
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The price of psychotropic drugs: a neglected factor.
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The roles of patents and research and development incentives in biopharmaceutical innovation.
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The use of 95% CI or 90% CI for drug product development - a controversial issue?
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Topical oxygen is not hyperbaric oxygen (HBO2).
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Treatment of steroid-refractory acute graft-versus-host disease with anti-CD147 monoclonal antibody ABX-CBL.
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Understanding therapeutic equivalence in epilepsy.
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Unified approaches to assessing treatment effect of traditional Chinese medicine based on health profiles.
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Using Medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities.