+1 (888) 794-0077

Regulatory

Tackling Development and Regulatory Challenges for Gene Therapies

Tackling Development and Regulatory Challenges for Gene Therapies

Gene therapies have been one of the fastest-growing fields of drug development. These therapies hold the potential to treat cancers and other “undruggable” diseases and could hold the key to saving millions of lives. But they also have unique characteristics that make...

4 Reasons Non-GLP Bioanalysis Matters for DMPK Testing

4 Reasons Non-GLP Bioanalysis Matters for DMPK Testing

DMPK testing helps drug developers investigate how a drug compound is absorbed, distributed, metabolized, and eliminated (ADME) by the body. The earlier these properties can be understood, the better – which is why many drug developers start the process with non-GLP...

Improving PROTAC Drugs with MetID Studies

Improving PROTAC Drugs with MetID Studies

Most drugs undergo some level of transformation once they enter the body. This metabolism process allows a drug's active pharmaceutical ingredient (API) to achieve its desired effect and eliminate it from the body. But metabolism can also be tricky. Metabolizing a...

What Are Metabolite Profiling & Identification Studies?

What Are Metabolite Profiling & Identification Studies?

Drug metabolism studies (the “DM” of DMPK) are a critical part of understanding drug efficacy and safety across the entire drug development continuum. In this blog, we provide an overview of metabolite profiling and identification studies, including: four types of...

Reproductive Toxicology & the EPA’s Tiered Testing System

Reproductive Toxicology & the EPA’s Tiered Testing System

The endocrine system comprises myriad glands, hormones and receptors throughout the body that regulate biological processes from birth to death. Chief among those processes is the differentiation, growth and function of the human reproductive system. Human...