11 Result(s)
within
Alfredo García-Arieta
-
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
Sex-by-formulation interaction in bioequivalence trials with transdermal patches
The existence of a sex-by-formulation interaction in bioequivalence studies implies that the bioequivalence results (i.e., the test/reference ratio of the pharmacokinetic parameters) obtained in one sex are no...
-
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
Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons
Adjusted indirect comparisons can be used to investigate bioequivalence between generic products that are bioequivalent with a common reference product. In previous work with generic tuberculosis medicines pre...
-
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 between generic tacrolimus products marketed in Spain by adjusted indirect comparison
The objective of the study was to investigate the relative bioavailability between the generic tacrolimus products that are presently authorized in Spain by adjusted indirect comparison. This was based on demo...
-
Article
Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO
The objective of this study was to compare different methods of adjusted indirect comparisons that can be used to investigate the relative bioavailability of different generic products. To achieve this goal, g...
-
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...
-
Article
Differences in lercanidipine systemic exposure when administered according to labelling: in fasting state and 15 minutes before food intake
The aim of this study was to compare the systemic exposure of lercanidipine (Zanidip) after oral administration in the fasted state and 15 min before food intake (meals) to investigate if the recommendations i...
-
Article
Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies
The aim of the present work was to assess the need for chiral bioanalytical methods in bioequivalence studies.
