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Publications & Comments

Search for publications, comments, and IQ presentations using the search bar on the left side of the page, or view recent publications, comments, and presentations by scrolling through the list below.

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 (https://www.regulations.gov/docket?D=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IQ CPLG Comments on FDA draft guidance on Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older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 (https://www.regulations.gov/document?D=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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