How to Mitigate the Risk of Selecting a Non-Enrolling Site for your Clinical Trial

whitePaper | March 15, 2022

Successes in 2021 – New active substance drug launches

whitePaper | May 25, 2023

CDER’s mission is to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients. To advance this mission, FDA’s Pharmaceutical Quality for the 21st Century Initiative promotes an efficient, agile, and flexible pharmaceutical manufacturing sector that reliably produces quality drugs without excessive regulatory oversight.

whitePaper | July 4, 2023

The past two decades have witnessed transformative changes in our approach to using modeling & simulation to assess and manage DDIs. Multidisciplinary innovations in mechanistic assessment of absorption, distribution, metabolism, and excretion (ADME), population pharmacology and pharmacogenetics.

whitePaper | July 7, 2022

The full drug target profile identification is many times a necessary step in drug development process. Recently, the move to a more holistic approach in drug discovery has resulted in the increasing use of cell-based assays to discover new biologically active small molecules.

whitePaper | October 14, 2022

Supply constancy, cost, sterility – even a subset of the factors that impact materials selection can be daunting for biopharmaceutical companies embarking on a new drug development project.

whitePaper | November 24, 2022

The pharmaceutical industry will face many challenges over the next decade, from industry-wide trends to new operational pressures. The key to meeting these challenges is adopting an agile, scalable and efficient approach to drug discovery and manufacturing.