Lista de obras -

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

artículo científico publicado en 2015

A Molecular Basis for Innovation in Drug Excipients

artículo científico publicado en 2016

A sensitivity analysis of the modified chi-square ratio statistic for equivalence testing of aerodynamic particle size distribution.

artículo científico publicado en 2013

A stability analysis of a modified version of the chi-square ratio statistic: implications for equivalence testing of aerodynamic particle size distribution.

artículo científico publicado en 2012

Analysis of bead sizes for MR capsules labeled for sprinkle

artículo científico publicado en 2010

Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension

artículo científico publicado en 2019

Application of the modified chi-square ratio statistic in a stepwise procedure for cascade impactor equivalence testing.

artículo científico publicado en 2014

Applications of process analytical technology to crystallization processes

artículo científico publicado en 2004

Bioequivalence approaches for highly variable drugs and drug products

artículo científico publicado en 2007

CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products

artículo científico

Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products

artículo científico publicado en 2016

Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items

artículo científico publicado en 2014

Confidence in generic drug substitution

artículo científico publicado en 2013

Correction to: Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover's Distance

scientific article published on 14 August 2020

Current Scientific Considerations to Verify Physiologically-Based Pharmacokinetic Models and Their Implications for Locally Acting Products

artículo científico publicado en 2019

Current challenges in bioequivalence, quality, and novel assessment technologies for topical products

artículo científico publicado en 2014

Decision Science for Generic Drug Development and Review

artículo científico publicado en 2019

Development of performance matrix for generic product equivalence of acyclovir topical creams

artículo científico publicado en 2014

Effect of device design on the in vitro performance and comparability for capsule-based dry powder inhalers

artículo científico publicado en 2012

Effects of device and formulation on in vitro performance of dry powder inhalers

artículo científico publicado en 2012

Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover's Distance

artículo científico publicado en 2018

Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

artículo científico publicado en 2015

Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

artículo científico publicado en 2015

FDA critical path initiatives: opportunities for generic drug development

artículo científico publicado en 2008

Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions

artículo científico publicado en 2020

Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach

artículo científico publicado en 2018

Generating Model Integrated Evidence for Generic Drug Development and Assessment

article

Generic Drugs: Expanding Possibilities for Clinical Pharmacology

artículo científico publicado en 2019

Generic development of topical dermatologic products, Part II: quality by design for topical semisolid products

artículo científico publicado en 2013

Generic development of topical dermatologic products: formulation development, process development, and testing of topical dermatologic products

artículo científico publicado en 2013

Generic omeprazole delayed-release capsules: in vitro performance evaluations.

artículo científico publicado en 2009

Generics 2030: Where Are We Heading in 2030 for Generic Drug Science, Research, and Regulation?

artículo científico publicado en 2020

Impact of P-glycoprotein-mediated intestinal efflux kinetics on oral bioavailability of P-glycoprotein substrates

artículo científico publicado en 2004

Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time

scientific article published on 29 October 2018

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration

artículo científico publicado en 2012

In Vivo Dissolution and Systemic Absorption of Immediate Release Ibuprofen in Human Gastrointestinal Tract under Fed and Fasted Conditions.

artículo científico publicado en 2017

In Vivo Predictive Dissolution and Simulation Workshop Report: Facilitating the Development of Oral Drug Formulation and the Prediction of Oral Bioperformance

artículo científico publicado en 2018

Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012

artículo científico publicado en 2019

Innovative approaches for demonstration of bioequivalence: the US FDA perspective

artículo científico publicado en 2013

Integrating In Vitro, Modeling, and In Vivo Approaches to Investigate Warfarin Bioequivalence

artículo científico publicado en 2017

International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

artículo científico publicado en 2015

Linking the Gastrointestinal Behavior of Ibuprofen with The Systemic Exposure Between and Within Humans - Part 1: Fasted State

artículo científico publicado en 2018

Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 2: Fed State

artículo científico publicado en 2018

Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs

artículo científico publicado en 2017

Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract

artículo científico publicado en 2016

Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

artículo científico publicado en 2017

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

article

Modeling and Mechanistic Approaches for Oral Absorption: Quality By Design in Action ⬇️

artículo científico publicado el 1 de febrero de 2012

Modeling and simulation of biopharmaceutical performance

scientific article published on 01 May 2014

Modeling and simulation of the effect of proton pump inhibitors on magnesium homeostasis. 1. Oral absorption of magnesium

artículo científico publicado en 2012

Novel bioequivalence approach for narrow therapeutic index drugs

artículo científico publicado en 2014

Pharmaceutical equivalence by design for generic drugs: modified-release products

artículo científico publicado en 2011

Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products

artículo científico

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology

scientific article published on 12 June 2019

Quality by design: concepts for ANDAs

artículo científico publicado en 2008

Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective

scientific article published on 07 January 2019

Scientific considerations in the review and approval of generic enoxaparin in the United States

artículo científico

The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation

artículo científico publicado en 2011

Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulations

artículo científico publicado en 2012

Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations

artículo científico publicado en 2012

Using partial area for evaluation of bioavailability and bioequivalence

artículo científico publicado en 2011

Utility of physiologically based absorption modeling in implementing Quality by Design in drug development

artículo científico publicado en 2011

Viscosity of bimodal and polydisperse colloidal suspensions

artículo científico publicado en 2002

Lista de obras de

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

A Molecular Basis for Innovation in Drug Excipients

A sensitivity analysis of the modified chi-square ratio statistic for equivalence testing of aerodynamic particle size distribution.

A stability analysis of a modified version of the chi-square ratio statistic: implications for equivalence testing of aerodynamic particle size distribution.

Analysis of bead sizes for MR capsules labeled for sprinkle

Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension

Application of the modified chi-square ratio statistic in a stepwise procedure for cascade impactor equivalence testing.

Applications of process analytical technology to crystallization processes

Bioequivalence approaches for highly variable drugs and drug products

CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products

Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products

Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items

Confidence in generic drug substitution

Correction to: Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover's Distance

Current Scientific Considerations to Verify Physiologically-Based Pharmacokinetic Models and Their Implications for Locally Acting Products

Current challenges in bioequivalence, quality, and novel assessment technologies for topical products

Decision Science for Generic Drug Development and Review

Development of performance matrix for generic product equivalence of acyclovir topical creams

Effect of device design on the in vitro performance and comparability for capsule-based dry powder inhalers

Effects of device and formulation on in vitro performance of dry powder inhalers

Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover's Distance

Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

FDA critical path initiatives: opportunities for generic drug development

Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions

Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach

Generating Model Integrated Evidence for Generic Drug Development and Assessment

Generic Drugs: Expanding Possibilities for Clinical Pharmacology

Generic development of topical dermatologic products, Part II: quality by design for topical semisolid products

Generic development of topical dermatologic products: formulation development, process development, and testing of topical dermatologic products

Generic omeprazole delayed-release capsules: in vitro performance evaluations.

Generics 2030: Where Are We Heading in 2030 for Generic Drug Science, Research, and Regulation?

Impact of P-glycoprotein-mediated intestinal efflux kinetics on oral bioavailability of P-glycoprotein substrates

Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration

In Vivo Dissolution and Systemic Absorption of Immediate Release Ibuprofen in Human Gastrointestinal Tract under Fed and Fasted Conditions.

In Vivo Predictive Dissolution and Simulation Workshop Report: Facilitating the Development of Oral Drug Formulation and the Prediction of Oral Bioperformance

Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012

Innovative approaches for demonstration of bioequivalence: the US FDA perspective

Integrating In Vitro, Modeling, and In Vivo Approaches to Investigate Warfarin Bioequivalence

International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

Linking the Gastrointestinal Behavior of Ibuprofen with The Systemic Exposure Between and Within Humans - Part 1: Fasted State

Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 2: Fed State

Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs

Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract

Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

Modeling and Mechanistic Approaches for Oral Absorption: Quality By Design in Action ⬇️

Modeling and simulation of biopharmaceutical performance

Modeling and simulation of the effect of proton pump inhibitors on magnesium homeostasis. 1. Oral absorption of magnesium

Novel bioequivalence approach for narrow therapeutic index drugs

Pharmaceutical equivalence by design for generic drugs: modified-release products

Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology

Quality by design: concepts for ANDAs

Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective

Scientific considerations in the review and approval of generic enoxaparin in the United States

The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation

Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulations

Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations

Using partial area for evaluation of bioavailability and bioequivalence

Utility of physiologically based absorption modeling in implementing Quality by Design in drug development

Viscosity of bimodal and polydisperse colloidal suspensions