The pharmaceutical development provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process.
Drug discovery:
Chemical Synthesis identification of lead compound, it is fist and initial stage of drug development mainly deals with chemistry.
Pharmacological property:
It deals with pharmacodynamics, pharmacokinetic part of drug substance and drug product like.
- Pharmacodynamics
- Effects
- Side effects
- Dose
- Safety
- Toxicity
- Pharmacokinetics
- Absorption
- Distribution
- Metabolism
- Excretion
- Formulation development
- Drug substance
The physicochemical and biological properties of the drug substance, that can influence the performance of drug product and its manufacturabiity eg.
- Solubility
- Water content
- Particle size
- Crystal properties
- Biological activity
- BCS classification
Drug product:
- Drug-drug interaction
- Drug excipient interaction
Manufacturing Technology:
Tech Transfers / Scale Up
- Formulation optimization based on in-house manufacturing equipment
- Pilot clinical trial materials and commercial-scale cGMP manufacturing
- Analytical method assessment transfer
- Commercial-scale process evaluation development
- Assessment of commercialized formulations including rheology
Process Validation
- Laboratory pilot cGMP-compliant clinical trial materials and cGMP commercial scale up
- Process identification evaluation and selection
- Assessment of commercialized formulations including rheology
- Process optimization
- Site and technology transfers
Analytical development:
- Development of testing method
- Development of dissolution method
- Comparative dissolution profiles
- Finalizations of product specification
- Analytical method transfer
- Analytical method validation
Post market surveillance
We have a special in house unit of pharmacovigilance and drug regulatory affairs, which deals with post marketing surveillance of drug product and market compline during the product lifecycle.
