Publications & Comments

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191 total entries

IQ Comments on Framework for Assessing pH-Dependent Drug-Drug Interactions

Date of Publication: July 24, 2018

Docket # FDA-2018-N-1820 (

Agency: FDA

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IQ DPLG Pediatric Working Group Webinar: Container Closure and Device Systems for Pediatric Combination Products

Date of Publication: May 04, 2018

Author(s): Matthew S. Thomas, Eli Lilly and Company

Venue: Webinar

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Harnessing the Transformative Potential of Emerging Technologies for Clinical Drug Development: From Promise to Reality American Society for Clinical Pharmacology and Therapeutics

Date of Publication: April 26, 2018

Author(s): Leslie Dickmann,  Prajakti A. Kothare; Pravin Jadhav; Pankaj Gupta

Corresponding Author: Jane Harrelson

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IQ CPLG Comments on FDA draft guidance on Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older

Date of Publication: April 10, 2018

Docket # FDA-2018-D-0178-0003 (

Agency: US Food and Drug Administration

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IQ Analytical Leadership Group’s ICH Q3D Working Group Resubmits Comments on USP General Chapter <661.1>

Date of Publication: April 05, 2018

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