Kevin V. Blake - Publications

Generic Long-Acting Injectable Product Availability and Approval Standards.

Journal: Pharmaceutical research

Published: May 13, 2026

Reply to: "Current Use of PBPK Modeling in New Medicinal Product Approvals at EMA: A Clinical Appraisal of Voclosporin in Lupus Nephritis".

Journal: Clinical pharmacology and therapeutics

Published: May 02, 2025

A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2.

Journal: Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques

Published: April 03, 2025

Current Use of Physiologically Based Pharmacokinetic modeling in New Medicinal Product Approvals at EMA.

Journal: Clinical pharmacology and therapeutics

Published: August 01, 2024

A Two-Way Proposal for the Determination of Bioequivalence for Narrow Therapeutic Index Drugs in the European Union.

Journal: Pharmaceutics

Published: March 13, 2024

Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective.

Journal: CPT: pharmacometrics & systems pharmacology

Published: October 13, 2022

Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union.

Journal: Pharmaceutics

Published: September 21, 2022

A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union.

Journal: Clinical pharmacology and therapeutics

Published: June 29, 2021

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications.

Journal: Clinical and translational science

Published: February 26, 2019

A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.

Journal: Pharmacoepidemiology and drug safety

Published: December 03, 2018

Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics.

Journal: British journal of clinical pharmacology

Published: November 08, 2018

Response to: "The Role of Quantitative Systems Pharmacology in the Design of First-in-Human Trials".

Journal: Clinical pharmacology and therapeutics

Published: June 08, 2018