While ominously scheduled for March 15, no such drama (like the assassination of Julius Caesar, the origins of ‘beware the Ides of March’) occurred during the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. It was quite productive, acknowledging the tremendous impact of modeling and simulation in drug development and regulatory review moving the technology further into the mainstream.
Month: March 2017
Learn how non-parametric approaches can be used to determine time scaling for in vitro-in vivo correlation (IVIVC).
In many ways, the strategic planning required to comply with EMA Policy 0070―a requirement to publish anonymized versions of clinical study reports (CSRs) and other submission documents―is similar to a secret agent’s mission: sponsors must keep the identities of people named or referred to in those documents top-secret while maintaining the document’s clinical utility. In … Continued
Delays are ubiquitous in pharmacokinetics (PK) and pharmacodynamics (PD) studies. Transit compartment models, described by systems of ordinary differential equations, have been widely used to describe delayed outcomes in PK and PD studies. The obvious disadvantage for this type of model is it requires manually finding proper values for the number of compartments. In addition, … Continued