Preclinical

What Is IND-Enabling Testing & What Does It Include?  

What Is IND-Enabling Testing & What Does It Include?  

IND-enabling testing is a cornerstone of the drug development process, helping researchers predict safety concerns and estimate safe and efficacious starting doses for clinical trials. Planning ahead, understanding the tests you need to conduct, and diligent tracking...

An Important First Step in the Design of a Preclinical Program

An Important First Step in the Design of a Preclinical Program

In the design of a preclinical program, identifying and understanding the broad classification of the molecule is the priority. Is it a small molecule, a chemical, a manufactured drug? Or is it a biologic or a large molecule, a construct of amino acids, providing a...

Guidance Updated by U.S. FDA for Safety Testing of Drug Metabolites

Guidance Updated by U.S. FDA for Safety Testing of Drug Metabolites

Recent guidance from the U.S. Food and Drug Administration (FDA) on Safety Testing of Drug Metabolites helps drug developers know when and how to identify and characterize drug metabolites. Identifying and characterizing a drug's metabolic profile is a necessary step...

Transitioning to Phase I Clinical Trials

Transitioning to Phase I Clinical Trials

Developing biologic solutions is a complex process, and bridging bioanalytical assays from preclinical to phase I clinical trials is a demanding step in advancing your therapeutic. While maneuvering through regulatory requirements and intensive testing, it is easy for...