Pharmaceutical Product Development Research Paper

1.0 Pharmaceutical development:
Pharmaceutical product development consist of a series of systematic processes can be divided into the following steps.
1. Pre clinical phases
2. Clinical trial phases
Pre clinical phases:
New chemical entities are compounds which emerge from the process of drug discovery. Drug development is required to establish the physicochemical properties of the NCE. These involve both invitro and invivo experiments including wide range of doses of the drug to be tested to establish safety and efficacy.
Clinical trial phases:
Clinical trial phases are divided into three types, Phase trail- 0,I, II, III,IV.
Phase - 0: these trials are known as human micro dosing studies. This phase is designed to speed up development of

Selection of mobile phase and the gradient condition is based on the ionogenic nature of the analyte .samples containing ionizable compounds are strongly influenced by the pH of the mobile phase .mobile phase should be chosen based upon the pKa of components. At low pH the mobile phase protonates the free silanols on the column and reduces tailing

Inorganic impurities
Inorganic impurities are normally detected and quantified using pharmacopoeial or other appropriate procedures. Carry-over of catalysts, ligands to the new drug substance should be evaluated during development.
Residual solvents
Residual solvents are the organic volatile chemicals that are used during manufacturing of drug substances, drug product and excipients. These solvents they don’t produce any therapeutic effect they should be removed to the extent possible to meet the specification limits as mentioned in the USP general chapter 467 and ICH guidelines which says the same.
Residual solvents class Assessment
Class 1 Solvents to be avoided known to be human carcinogens
Class 2 Solvents to be limited, non