Drug Metabolism & Pharmacokinetic Research Preclinical Development Services

Drug discovery and development can be divided into three broad areas: Discovery, Preclinical Development and Clinical Research. Preclinical Development disciplines usually include Toxicology, Pharmaceutical Sciences and "Drug Metabolism & Pharmacokinetic Research". PharmOptima scientists are experienced with many aspects of Drug Metabolism & Pharmacokinetic Research and offer a wide range of non-GLP and GLP regulated services.

OUTLINE OF SERVICES
Drug Metabolism & Pharmacokinetic Research

In Vitro Metabolism

• In vitro metabolism assessment
• Microsomal metabolism
• Hepatocyte metabolism
• Expressed cell metabolism
• Assessment of the metabolic profile for determination of the metabolic route(s) of metabolism, and, the CYP isozyme characterization of the route(s) of metabolism
• CYP drug-drug interaction assessment
• Enzyme induction/inhibition studies
• Plasma protein binding assessment

In Vivo Metabolism

• Absorption, distribution, metabolism, excretion (ADME) in vivo assessment with or without radiolabeled drugs.

Pharmacokinetics Analysis

• Preclinical Pharmacokinetics
• PK/PD assessment
• Toxicokinetic assessment
• Investigations of absorption and clearance
• Bioavailability/bioequivalence
• Ocular PK
• Cassette (N in 1) dosing and analysis

Discovery ADME

• Fast turn-around of studies and expert consultation for early "Discovery ADME"

Drug Metabolism & Pharmacokinetic Research Analytical:
The equipment necessary to conduct these studies is present in PharmOptima laboratories and in the Core Laboratory of the Southwest Michigan Innovation Center. This equipment includes state-of-the-art LC equipment with a full complement of detectors (DAD, UV/Vis, Radiomatic and FL). Our primary analytical instruments are SCIEX 3000, CTC Analytics HTS-PAL and Agilent 1100 HPLC.

Frequently asked questions about Drug Metabolism & Pharmacokinetic Research Preclinical Development

1. What are pharmacokinetics and ADME and why are they important?
2. When should ADME characteristics be determined in the drug discovery funnel?
3. Why are ADME studies so important to my company's success?
4. What is the experience level of the Drug Metabolism & Pharmacokinetic Research scientists at PharmOptima