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Lead selection & optimization (iterative)

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

Drug Candidate conformation Preclinical Drug Characterization


Process Chemistry & Scale up ( 20 g to 100 g) GMP Batch (100 g) ICH stability of drug and the product ICH impurity Analysis and GLP formulation Prototype clinical formulation Manufacturing of CTM- clinical trial material Further Impurity & Formulation analysis Validated analytical methods Comprehensive Pharmacokinetics Toxicokinetics Metabolite identification Mass Balance in rodents and dogs Fast & fed PK & Biliary excretion in rodents and dog Investigation of Human CYP isoforms GLP acute Tox GLP sub chronic repeat dose rats &dogs GLP genotoxicity Safety profile (CVS, CNS, Renal, respiratory, Irwin ,Purkinji , GI tract) in Rat and dog. hERG

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

Efficacy & ADME

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

Assay Development & HTS- High Throughput screening


Activity of the NCE at enzymes , receptors, ion channel , signal transduction pathways etc In-vitro and HTS is used to find out the efficacy and selecting alternate lead.
Animal model with therapeutic focus.

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.