Jared W. Fennell

A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies

Chris Barber, Vincent Antonucci, Jens-Christoph Baumann et al. · Regulatory Toxicology and Pharmacology · 2017 · 33 citations

Control Method, Control Strategy, Engineering +8

Approaches and Considerations for the Investigation and Synthesis of <i>N</i>-Nitrosamine Drug Substance-Related Impurities (NDSRIs)

Ian W. Ashworth, Alexander Blanazs, Jonathan J. Byrne et al. · Organic Process Research & Development · 2023 · 31 citations

Risk Assessment, Combinatorial Chemistry, Medicinal Chemistry +13

Use of Modeling and Process Analytical Technologies in the Design of a Catalytic Amination Reaction: Understanding Oxygen Sensitivity at the Lab and Manufacturing Scales

Jeremy M. Merritt, Jonas Y. Buser, Alison N. Campbell et al. · Organic Process Research & Development · 2013 · 27 citations

Engineering, Mechanistic Approach, Organic Chemistry +17

New Semi-Automated Computer-Based System for Assessing the Purge of Mutagenic Impurities

Michael J. Burns, Martin A. Ott, Andrew Teasdale et al. · Organic Process Research & Development · 2019 · 23 citations · Full text

The Role of New Technologies in Defining a Manufacturing Process for PPARα Agonist LY518674

Mark D. Argentine, Timothy M. Braden, J. Czarnik et al. · Organic Process Research & Development · 2009 · 17 citations

Impurity Tracking, New Technologies, Engineering +18