YalePharma has for decades provided the research community with studies of the absorption, distribution, metabolism, and excretion of drug substances. YalePharma's capabilities are enhanced by specialists in the areas of toxicology, pharmacokinetics, medicinal chemistry, and pharmacology. ADME testing is supported by staff conducting radiolabel, stable label, and general organic synthesis.

ADME Capabilities

YalePharma can provide preclinical support for pharmaceutical industry through:

• Dose formulation preparation and analysis including radiolabeled compounds and DEA controlled substances
• Specialized laboratory animal surgeries including cannulations of biliary and lymphatic ducts, jugular and femoral veins, and the carotid artery
• Dose administration to laboratory animal species by dermal, oral, injectable, and inhalation routes
• Tissue distribution determinations of parent compound and metabolites
• Determination of rates and routes of excretion
• Pharmacokinetic studies and calculation of relevant parameters including absorption, distribution, and elimination rate constants and half-lives, relative bioavailability and bioequivalence, clearances, and volumes of distribution
• Characterization of metabolites in biological samples
• Regulatory compliance monitored by an independent Quality Assurance Unit (FDA, EPA, OECD, and MHW regulations).

Research Facilities

YalePharma has extensive laboratory facilities and equipment for ADME testing:

Dose Formulation Laboratories: environmentally-controlled stability testing; quality control, dissolution and disintegration testing; solubility profiles; moisture and residual solvent assays; DEA controlled substances storage facilities

In-life Metabolism Laboratory Suite: located within AAALAC-accredited animal research facility; metabolism chambers for collection of urine, feces, and volatiles; nose-only inhalation apparatus; small animal surgery facilities

Liquid Chromatography: analytical and semi-preparative with radiochemical, UV/VIS, photodiode array, MS, EC, RI, ELS, and fluorescence detection

Gas Chromatography: capillary, megabore, and packed column; FID, NPD, and EC detection

Mass Spectrometry: LC/MS, GC/MS, MS/MS; EI, CI, NICI, FAB, APCI, and ESI modes

NMR Spectrometry: multinuclear FT-NMR; 300 and 500 MHz; 2D correlation spectra

High-Level Radioactivity and Toxic Substances Laboratories: fully OSHA compliant