|
 |
Preclinical Development
 Technologies &
Capabilities
 |
| Analysing extracted drug levels in plasma samples |
S*BIO’s in-house Preclinical Development activities include physicochemical and ADME profiling of hits and lead compounds; for example:
- Integrity profiling (purity and identity)
- Stability monitoring (chemical and formulation)
- Solubility profiling (Kinetic and Thermodynamic)
- In vitro ADME and in vivo PK studies:
- Metabolic stability assays in liver microsomes (human, dog, rat and mouse)
- Parallel Artificial Membrane Permeability Assay (PAMPA)
- Plasma protein binding assay using equilibrium dialysis
- Metabolite Identification using LC/MS/MS
- P450 Inhibition and phenotyping assay using LC/MS/MS
- Pharmacokinetics in mice, rats (in-house) and dogs (in-life in CRO)
- LC/MS/MS assays for quantification of analytes in biological matrices (plasma and tissues) in support of mouse, rat and dog PK studies
 |
| Blood collected for analysis |
These studies help S*BIO optimize compounds for superior drug metabolism and pharmacokinetic properties in humans. Early stage optimization of lead compounds for ADME properties enable the identification of PDCs (Preclinical Drug Candidates) with good PK/PD (pharmacokinetic/ pharmacodynamic) attributes. S*BIO’s state-of-the-art wet labs, vivarium and bioanalytical facilities and in-house expertise support the projects to identify best-in-class molecules with respect to drug metabolism and pharmacokinetic properties.
Further to the nomination of the PDC, the Preclinical Development team interacts with the toxicology and bioanalytical CROs (Contract Research Organisations) to conduct GLP safety pharmacology, dose-range finding studies, and acute and chronic toxicology studies in rodents and non-rodent species. In the two Investigational New Drug (IND) filings done to date, efficient project management with CROs meant the entire preclinical development process was complete in a rapid timeframe of less than a year
 Back to top
Copyright © 2002-2011 S*BIO Pte Ltd. All rights reserved.
|
|
