5 Result(s)
within
Alfredo García-Arieta
Pharmacy
-
Chapter
Regulatory Requirements and Applications of Physiologically Based Pharmacokinetic Models
Physiologically based pharmacokinetic (PBPK) models have become a key tool to reduce the uncertainty and assure the best benefit-risk decisions in a model-informed drug discovery and development process. Since...
-
Article
Global Harmonization of Comparator Products for Bioequivalence Studies
Comparator products should be the products that were shown to be safe and efficacious in pivotal clinical trials to ensure prescribability of generics. The use of a common comparator ensures switchability betw...
-
Article
Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India
This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP i...
-
Article
Bioequivalence Requirements in the European Union: Critical Discussion
The aim of the present paper is to summarize the revised European Union (EU) Guideline on the Investigation of Bioequivalence and to discuss critically with respect to previous European requirements and presen...
-
Article
Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence
This summary workshop report highlights presentations and over-arching themes from an October 2011 workshop. Discussions focused on best practices in the application of biopharmaceutics in oral drug product de...
