Pre-Clinical Research
| In Vitro ADME ( under establishment ) | Assayas |
|---|---|
|
Absorption / Permeability |
Caco-2 Bi-directional, PAMPA & MDCK |
|
Distribution |
Plasma protein Binding, Brain Tissue Binding & Blood Partitioning |
|
Metabolism |
Metabolic Stability, Drug-Drug Interactions |
| In Vivo Pharmacokinetics | Attributes |
|---|---|
|
Rodent PK |
Design: Single / Multiple / Cassette Dose, Cross-over Dose proportionality (Ascending dose), Dose linearity (Multiple dose), Bioavailability (Extra vascular versus Intravenous) & Bioequivaence (Test versus Reference), Effect of Food & Gender different, etc. |
|
|
ROA: PO, IV, IP, SC, IM, Dermal, Ocular, SC, Nasal, Buccal etc. |
|
|
Sample Matrices: Plasma, Blood, Urine, Feces, CSF, Tissues, Sysnovial fluid |
|
Large Animal PK |
Design: Single / Multiple Dose, Cross-over, Dose Escalation, Bioavailability & Bioequivalence, Effect of Food & Gender |
|
|
ROA: PO, IV, IM, & Dermal |
|
|
Sample Matrices: Plasma, Blood, Urine & Feces |
| Pharmacodynamic / Biomarker Assessment | Attributes |
|---|---|
|
Receptor Occupancy / Specific Pharmacodynamic activity |
Single dose or Repeated dose studies in rodents and non-rodents |
| Non-GLP Toxicology | Attributes |
|---|---|
|
Exploratory |
Single dose, 7-day or 14-day repeat dose studies |
|
Maximum Tolerated Dose |
Determination of MTD and NOAEL |
|
Species |
Rodent |
| Bioanalysis | Attributes |
|---|---|
|
Instrument |
Sciex Triple Quad 4500 LC-MS/MS |
|
UHPLC |
Exion LC AD UHPLC System with Multiplate Autosampler |
|
Solutions |
Small Molecules, Peptides and Biomarkers-Qualification & Quantitation |
|
Methods |
Fit-for-purpose, Method Validation, Single-Analyte, Multi-Analyte, Proprietary methods |
|
Matrices |
Plasma, Serum, Whole Blood, Tissues, Urine, CSF, Synovial Fluid, Aqueous Humor, Ocular Tissues, Gingival Crevicular Fluid |
|
Data Analysis |
Phoenix Win-Nonlin Software |