Escolar Documentos
Profissional Documentos
Cultura Documentos
Synthetic & medicinal chemistry Lead Optimization 1to 5 gram scale up Polymorph studies Prototype formulations Solubility & Stability APl characterization Methods dev. & Validation Impurity identification in-vitro and in-vivo & Ex-vivo Screening In vitro alt. lead Final lead in-vivo
CMC
Chemistry Manufacturi ng Control
Process development Formulation for Toxicity Detailed Physicochemical characterization Further Impurity & Formulation analysis
Benchmark the disease model Microsome , Hepatocytes Oral Bioavailability Basic PK/PD relationship Metabolite profiling Protein Binding CYP inhibition &induction Max tolerated dose Repeated dose 7-10 days Prelim CVS Acute tox 28 day tox including toxicokinetics
In-sillico profiling & Simple analytical method . Membrane permeability & Plasma stability Primate PK/PD Plasma stability
Toxicology
Off target screen Cyto-toxicity, prelim AMES Screening hERG binding Genetic toxicity
Efficacy model focus on therapeutic areas such as Pain, inflammation ,Metabolic disorder, cancer, CVS, Dislipidaemia, Anti infective ,auto immune diseases Assessment such as Clinical, joint pathology, immunology, disease progression and other drug specific parameters
ADME Services
It
is carried out during the lead optimization of NCE and this helps In reducing the time and cost of the discovery Absorption disposition, metabolism and excretion parameters will help to determine the desirable Drug able properties .
Metabolite identification
By identifying the susceptibilities and issues and metabolic path way of the NCE help to take decision on merit of further development of the drug candidate
Toxicology Service
Assays/ Studies such as in-vitro, or on mammalian or cultures bacteria , in-vivo on rodents will help to determine the extend of liability of NCE
Pre-formulation
Physicochemical properties like stability will help us determine the stability of the drug under various conditions and further help us developing correct delivery system.