Expert IND-enabling studies and regulatory support for pharmaceutical development
IND & NDA enabling studies, Impurity qualification & Bridging studies for regulatory submissions & 505 (B2) strategies.
IND-enabling studies
IND-enabling studies are performed to evaluate the efficacy and safety of the new drug.
The pharmacology studies (efficacy) most frequently consist of in vitro (cell based) and in vivo (whole animal) experiments that validates the potential of desired effect of the new drug. This is often done in animal models that mimic human disease.
The Toxicology studies (safety) evaluate the safety profile of the drug. This includes assessing the effect on DNA (genotoxicity), critical organ systems i.e., effects on cardiovascular, respiratory, and central nervous system (safety pharmacology), and general toxicity (rodent and nonrodent species).
During the IND-enabling studies, the data explains systemic exposure to the drug, the exposures and nature of adverse effects at high dose levels, and the safety margin.
Exploratory toxicology
- PK- compartmental & noncompartmental analysis using WinNonlin®
- PK- bioavailability / bioequivalence
- Toxicokinetics
- MTD/dose limiting toxicology studies
- Dose escalation toxicology studies
- Genotoxicity screening
DMPK studies
- In Vitro assays
- Caco-2 permeability
- Plasma protein binding
- Solubility
- Microsomal stability
- Blood / plasma ratio
- CYP inhibition assays
- CYP induction
Genetic toxicology testing
- Ames test
- Chromosomal aberration (In vitro / In vivo)
- Micronucleus test (In vitro / In vivo)
- Mouse lymphoma
- Comet assay
Mammalian toxicology
- Single dose studies
- Repeated dose studies
- Chronic toxicology studies
- Carcinogenicity
- Developmental & reproduction toxicology (DART)
- Ocular toxicology
- Infusion toxicology
- Inhalation toxicology
- Musculoskeletal toxicology
- Neurotoxicology
- Ocular irritation models
- Ototoxicity testing
- Phototoxicity testing
- Skin irritation, corrosion and sensitization
Analytical / bioanalytical capabilities
- Formulation method development, validation & dose formulation analysis
- Bioanalytical method development, validation & sample analysis for toxicokinetics (TK) / pharmacokinetics (PK)
Safety pharmacology studies
- FOB / irwin test
