Drug developers see Food and Drug Administration approval as a difficult uphill climb, requiring large investments of resources and time. But when it comes to new drug applications and biologics license applications, it’s usually (…)
Authors: Craig R. Rayner, Patrick F. Smith, David Andes, Kayla Andrews, Hartmut Derendorf, Lena E. Friberg, Debra Hanna, Alex Lepak, Edward Mills, Thomas M. Polasek, Jason A. Roberts, Virna Schuck, Mark J. Shelton, David Wesche, Karen Rowland‐Yeo Abstract Model‐informed drug development (MIDD) has a long and rich history in infectious diseases. This review describes foundational … Continued
Authors: Xian Pan, Felix Stader, Khaled Abduljalil, Katherine L. Gill, Trevor N. Johnson, Iain Gardner & Masoud Jamei Abstract Physiologically-based pharmacokinetic (PBPK) modelling provides an integrated framework to predict the disposition of small molecule drugs in children and is increasingly being used for dose recommendation…
By: EFPIA MID3 WorkgroupSF MarshallR BurghausV CossonSYA CheungM ChenelO DellaPasquaN FreyB HamrénL HarnischF IvanowT KerbuschJ LippertPA MilliganS RohouA StaabJL SteimerC TornøeSAG Visser Abstract This document was developed to enable greater consistency in the practice, application, and documentation of Model‐Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. A collection of “good practice” recommendations are … Continued
by Patrick Smith and Karen Rowland, PhD To read the article click below.
Posted on: https://futurism.com/By: Dan Robitzski It goes without saying that the coronavirus vaccine rollout in the United States has gone, well, imperfectly. Despite its ambitious goals, the Trump administration failed to communicate — and perhaps even fully develop — a COVID-19 vaccination plan until the first shots were already being shipped out…
Alison Dillman,1 Michael J Zoratti,2 Jay JH Park,3 Grace Hsu,2 Louis Dron,2 Gerald Smith,2 Ofir Harari,2 Craig R Rayner,4 Noor-E Zannat,2 Alind Gupta,2 Eric Mackay,5 Paul Arora,6 Zelyn Lee,7 Edward J Mills2 A multitude of randomized controlled trials (RCTs) have emerged in response to the novel coronavirus disease (COVID-19) pandemic. Understanding the distribution of trials among various settings is important to guide future research priorities and efforts. The … Continued
The Pharmacy department of the Shanghai Chest Hospital is dedicated to developing and applying model-informed precision dosing (MIPD) and model-informed drug development (MIDD) models to optimize dosing for patients in China. Certara has partnered with Professor Jiao for 20 years to provide academic training to graduate students and researchers on using its pharmacometric software, including … Continued
By Taren Grom Real-world evidence, important for regulatory decision-making, is beginning to touch all areas of the healthcare value chain.