At the InterPhex pharmaceutical exposition, which concludes today in New York, the booths of small companies offering early-stage discovery and testing services were noticeably more crowded than one would expect at a pharmaceutical manufacturing show. As one the marketing manager of one such firm pointed out, "This is where our customers are."
For example Northview Laboratories (Northview, IL; Booth 107) is showcasing a number of essential support services for drug developers, including expanded pharmacology testing. As part of a continuum of regulatory requirements for bringing new drugs to market, pharmacology seeks to answer:
- What are the compound's basic pharmacological and pharmacokinetic (PK) properties?
- How much of a drug is absorbed?
- How long does it take the body to absorb, distribute, metabolize, and excrete the drug?
- Which metabolic by-products remain in the body and which ones are excreted?
Pharmacokinetic (PK) studies generally involve oral or intravenous administration of the test compound to animals, followed by collection of samples of body fluids and wastes at designated time points. The samples (e.g. serum, plasma, whole blood, urine) are then sent back to the client for biochemical analysis.
"Our clients have been asking for an increasing number of PK studies over the last several years, and we expect that trend to accelerate," said Timothy Doherty, a veterinarian and Director of in vivo services at Northview. "FDA expects every drug company to do one or more pharmacokinetic studies for each product in their pipeline."
Northview currently performs PK projects on mice, rats, and swine for small-scale metabolic studies. In the future, Doherty foresees greater use of large animals such as dogs. "To accommodate this type of study, we will have animal rooms designed to house more than 100 dogs, along with a significantly enlarged rodent suite."
Northview will also offer other services that complement PK testing, such as safety pharmacology. These studies involve detailed physiologic monitoring (e.g. behavior, respiratory rate, organ function) after drug administration. The company's decision to expand pharmacology offerings is market-driven, according to Doherty. "Our clients need these services, and we are striving to meet their needs."
For more information: Timothy Doherty, Northview Laboratories, 1880 Holste Rd., Northbrook, IL 60062. Tel: 847-564-8181. Fax: 847-564-8269.
By Angelo DePalma