WASHINGTON, May 3, 2021 /PRNewswire-PRWeb/ -- As a continuation of the IQ Consortium's 10th Anniversary celebration, the IQ Consortium is excited to announce the publication of a special section in the Pharmaceutical Technology Regulatory Sourcebook eBook series. The International Consortium for Innovation & Quality in Pharmaceutical Development (IQ Consortium, http://www.iqconsortium.org) is a technically focused organization of pharmaceutical and biotechnology companies, whose mission is to advance science and technology to augment the capability of member companies to develop transformational solutions that benefit patients, regulators, and the broader R&D community. The IQ Consortium is comprised of 2200 scientists from nearly 40 member companies and focuses on diverse components of drug discovery and development, including drug metabolism, clinical pharmacology, preclinical safety, 3Rs, active pharmaceutical ingredients, drug products, and other topics.
The manuscripts in the recently released eBook provide insights into five case study areas developed by selected Working Groups and Leadership Groups within the IQ Consortium. The case studies focus on key areas of interest, including nitrosamine impurities, biologics CMC challenges, physiologically-based pharmacokinetic modeling, and pediatric therapeutic development.
IQ Consortium Articles Published in Pharmaceutical Technology Regulatory Sourcebook eBook:
- The "Managing the Risk of Nitrosamine Impurities" article describes the activities occurring within the IQ Nitrosamine Working Group to improve the understanding of the nature of nitrosamines and inform industry, consumers, and regulators about the important associated risks (Curran and Bercu).
- The IQ Consortium Biologics CMC Leadership Group's article on "Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies" highlights the findings from two Working Group studies conducted to identify emerging CMC challenges in accelerated product development, global harmonization, and data integrity (S. Ramdas, B. Rellahan, et al.).
- The "Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling" article by the Translational and ADME Sciences Leadership Group provides an overview of the basic principles of physiologically-based pharmacokinetic modeling and demonstrates its impact in streamlining the drug development process (H.J. Einolf, J. Sydor, et al.).
- The IQ Consortium CPLG Pediatric Working Group's article, "Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development" presents the findings from several new case studies, which illustrate how the application of the extrapolation framework allows for optimization of pediatric programs. The paper also describes the Pediatric Working Group's critical role fostering the implementation of the EXF to accelerate children's access to effective and safe medicines (S. Haertter et al.).
- The Quality Leadership Group's article, "Collaborative Efforts Address Key Data Integrity Challenges" describes the IQ Consortium's commitment to fostering collaboration and information sharing between quality disciplines to support innovative drug development approaches (G. Mohan, C. Turner et al).
The IQ Consortium's publication in the PharmTech eBook builds on the "Viewpoint: Precompetitive Collaboration Drives Pharma Industry Innovation" article previously published in October 2020 to commemorate the Consortium's 10th anniversary (Faul et al.). This article provides an overview of the IQ Consortium's history and structure, describes its foundational principles and mission, and highlights its impressive impact on the life sciences industry over the past 10 years. Looking to the future, the IQ Consortium will continue to prioritize industry collaboration and data sharing to help find innovative solutions to today's evolving critical issues.
Maja Leah Marshall, IQ Consortium, +1 202-230-5331, [email protected]
Clare Kuzma Sullivan, IQ Consortium, 202-230-5331, [email protected]
SOURCE IQ Consortium