| |
Sinclair Research Center provides GLP-compliant In
Vivo DMPK services from discovery through development
in our new state-of-the-art facility near Columbia,
Missouri.
  |
Drug Discovery/Drug
Development • Radiolabeled and Non-Radiolabeled
Test Articles
• Blood, Plasma, and Tissue Concentration ¨
• Mass Balance/Excretion (14C & 3H)
• QWBA (In Vivo at Sinclair, Sectioning and
Analysis
Subcontracted) |
|
• Pharmacodynamics
• Biliary Excretion (mouse, rat, dog) • Volatile
Collection • Metabolic Caging for Multiple Species
(rodent, cat,
dog, goat, swine) |
  |
Pharmacokinetics/Toxicokinetics
• Pharmacokinetics/Toxicokinetics ¨ • Single
or Multiple Dosing (In-life) • IVGTT, OGTT,
& Glucose Clamps |
|
• Bioequivalence & Bioavailability
• PK/TK Analysis
• Meal Interference/Glycemic Challenge
|
  |
Routes of Dose Administration
• Parenteral (IV/SC/IM/IP) • IV Infusion
• Intranasal ¨ Rectal / Intravaginal • Dermal
/ Intradermal / Transdermal patch • Vascular
Access Ports (VAP) • Rodent Vascular and Non-Vascular
Cannulas |
|
• Ocular • Auricular
• Rectal / Intravaginal • Oral (gavage / liquid
/ tablet / capsule) • Intracoronary / Intraventricular
(percutaneous access) |
  |
Test Facility
• AAALAC Accredited Facility – Since 1995
• Rodents (Mouse, Rat, Hamster) • Canines
• Domestic and Miniature swine (Sinclair, Yucatan,
Hanford) |
|
• High Capacity for Small and
Large Animals • Rabbits
• Felines
• Non-Human Primates •
Other Species Available |
  |
Analytical Support
– Alliance Partner Service •
Discovery and GLP-compliant bioanalytical chemistry
services (SRC Alliance Partner, ABC
Pharma Services)
• Sample Analysis-Routine Bioanalysis Quantitative
Analysis of Drug and Metabolites in Biological Matrices
Dose
Formulation Analysis, Interference Testing •
Analytical Method Development, Validation (Full,
Cross, & Partial), Method Transfer & Sample
Analysis
(LC-MS/MS, HPLC, ICP-MS, EIA, RIA, CZE, and Immunoblots)
• Dose Analysis (Radiochemical Purity, Specific
Activity) • Metabolite Characterization &
Identification • In addition to 14C labeling
ABC Laboratories has experience with the following
isotopes: 3H,
35S, 32P, 90Y, 111In, 166Ho, 188Re, 99mTc, and others.
• Immunoassays ELISA
and RIA (125I) Method
Development and Validation, Routine Sample Analysis
• SRC can also work with the Sponsor’s in-house
analytical laboratory or with a Sponsor designated
analytical
laboratory in support of the studies.
|
|
|