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View article: ICH M12 Drug Interaction Studies: Summary of the Efforts to Achieve Global Convergence
ICH M12 Drug Interaction Studies: Summary of the Efforts to Achieve Global Convergence Open
The ICH M12 Guideline on Drug Interaction Studies is the result of a harmonization process led by global regulatory and industry experts with experience in drug–drug interaction (DDI) assessments and interpretation. The Expert Working Grou…
View article: Utility of Biomarker‐Informed Drug Interaction Evaluation in Drug Development and Regulatory Decision Making
Utility of Biomarker‐Informed Drug Interaction Evaluation in Drug Development and Regulatory Decision Making Open
The measurement of endogenous biomarkers in plasma and urine before and after administration of an investigational drug in a clinical study may provide an early indication of its drug–drug interaction (DDI) potential via a specific pathway…
View article: Phase 1 Dose‐Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Tofacitinib in Japanese Healthy Volunteers
Phase 1 Dose‐Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Tofacitinib in Japanese Healthy Volunteers Open
The aim of the study was to characterize the pharmacokinetics, safety, and tolerability of tofacitinib, an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis in healthy Japane…
View article: Model‐Based Comparison of Dose‐Response Profiles of Tofacitinib in Japanese Versus Western Rheumatoid Arthritis Patients
Model‐Based Comparison of Dose‐Response Profiles of Tofacitinib in Japanese Versus Western Rheumatoid Arthritis Patients Open
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). The aim of this analysis was to characterize the relationship between tofacitinib dose and efficacy, as measured by American College of Rheumatol…