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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...

GLP vs. Non-GLP toxicology studies: When to use which guidelines?

GLP vs. Non-GLP toxicology studies: When to use which guidelines?

Since 1978, when the U.S. FDA issued the Guidance for Industry Good Laboratory Practices Regulations, Good Laboratory Practices (GLP) have been an essential part of the quest to ensure the highest standards in drug development.  GLP regulations have ensured that...

The Inherent Challenges of Antibody-Drug Conjugate (ADC) Bioanalysis

The Inherent Challenges of Antibody-Drug Conjugate (ADC) Bioanalysis

Antibody-drug conjugates (ADCs) target and destroy cancer cells like few available therapies. Highly potent and laser-focused, these tools have been around since 2000; currently, just 14 of them have been approved for use. ADCs are made up of a monoclonal antibody, a...

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...