Hari C. Sachs - Publications

Characterization of Plasma Protein Alterations in Pregnant and Postpartum Individuals Living With HIV to Support Physiologically-Based Pharmacokinetic Model Development.

Journal: Frontiers in pediatrics

Published: June 05, 2021

Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019.

Journal: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

Published: July 01, 2020

Exposure-Response Assessment in Pediatric Drug Development Studies Submitted to the US Food and Drug Administration.

Journal: Clinical pharmacology and therapeutics

Published: October 16, 2019

Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting.

Journal: Journal of clinical pharmacology

Published: September 04, 2019

Development of Drug Therapies for Newborns and Children: The Scientific and Regulatory Imperatives.

Journal: Pediatric clinics of North America

Published: November 28, 2017

Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary.

Journal: Clinical pharmacology and therapeutics

Published: January 18, 2017

Drug development for pediatric neurogenic bladder dysfunction: dosing, endpoints, and study design.

Journal: Journal of clinical pharmacology

Published: May 22, 2014

Alternate endpoints and clinical outcome assessments in pediatric ulcerative colitis registration trials.

Journal: Journal of pediatric gastroenterology and nutrition

Published: October 15, 2013

The transfer of drugs and therapeutics into human breast milk: an update on selected topics.

Journal: Pediatrics

Published: August 28, 2013

Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007.

Journal: JAMA pediatrics

Published: August 08, 2013

Strategic biomarkers for drug development in treating rare diseases and diseases in neonates and infants.

Journal: The AAPS journal

Published: October 25, 2012

Extrapolation of adult data and other data in pediatric drug-development programs.

Journal: Pediatrics

Published: October 26, 2011