Overview
Sequent Development offers both GLP-compliant preclinical toxicology in vivo studies for INDs as well as non-GLP toxicology and pharmacology in vivo and in vitro studies in order to provide preliminary assessment of a drug’s safety and efficacy. We have a core competency in performing safety pharmacology studies following established SOP’s and ICH standards.
Our in vivo preclinical services include pharmacokinetics, safety pharmacology, toxicology and efficacy studies. We have expertise in a range of diseases and disorders including oncology, cardiovascular disease, diabetes, neurological disorders, pain, analgesics, and wound healing.
Our comprehensive IND package includes the following drug and vaccine studies and services:
ADME Studies
- Drug screening for absorption, distribution, metabolism, excretion, and toxicity (ADMET)
- Drug pharmacokinetic (PK) and toxicokinetics studies
- In vitro (Caco-2) and in vivo bioavailability and bioequivalence drug screening
- Single dose toxicity (acute toxicity)
- Maximum tolerated dose
- Repeated dose toxicity (sub-chronic and chronic toxicity)
- Neurotoxicity
- Immunotoxicity
- Irritation and sensitization tests
- Reproductive toxicity
- Genotoxicity
- Carcinogenicity
Safety Pharmacology Studies
- Central Nervous System
- Cardiovascular System
- Respiratory System
- Efficacy studies using animal models
- In vitro screening of potential drug candidates in early drug discovery
