Drug discovery and development process aims to make available new pharmacological interventions to prevent, treat or cure disease in a safe and effective manner.
The idea for developing new drug can come from a myriad of sources including the current necessities of the market, new emerging diseases, academic, clinical research and from the commercial sector.
It may take many years to build up a supporting evidence before selecting a target for drug discovery programme.
Drug development starts with a target identification and validation, followed by drug candidates (hits) discovery, and selection and optimization of lead drug i.e. compound with favorable safety, efficacy, and pharmacokinetic profile.
Preclinical efficacy, pharmacology, toxicology, and mechanistic studies, using in silico (computational) methods, in vitro animal or human tissues and in vivo animals, are carried out for lead compound.
Subsequent to preclinical evaluation, an Investigational New Drug (IND) application is submitted to the regulatory agency summarizing all preclinical data along with a rationale for the proposed clinical study and a clinical study design.
Clinical studies can commence after approval by the regulatory agency and by the local Institutional Review Board.
Drugs emerging from these trials with appropriate evidence of safety and efficacy are submitted for marketing approval via New Drug Application (NDA).
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