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 related 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 early development/late discovery studies
