Drug-Drug Interaction (DDI) sample analysis

Analysis

Bioanalysis, Metabolism, LC-MS, IChem

Nonclinical drug-drug interaction (DDI) studies need to be carried out prior to an IND/CTA.

A key component of developing a drug for market use is to test for how it might interact with other drugs or substances in the human body. DDIs can present as mechanistic or static drug-drug interactions among APIs and their metabolites for any species. DDIs are studied to assess the potential risk-benefit profile of new treatments to determine any adjustments to dosage, therapeutic monitoring or contraindications for use that need to be taken into account prior to prescribing.

DDIs can occur with drugs already being prescribed and must be identified promptly to avoid serious consequences for patients and to instruct future drug development.

Use of predictive pharmacokinetic (PK)/pharmacodynamic (PD) modeling and simulation of preclinical tests prior to clinical or First-in-Human (FIH) studies are tools available to help determine a compound's potential interaction with other substances.

Molecule or Product Type

Biologics, Small Molecule

Models

Human

Regulatory

IND & CTA, NDA & BLA, Post-Market

Industry Market

Pharma

Phase

Clinical, Discovery, Nonclinical

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