Introduction to Drug Discovery and Development.

- Product Development - Pharmaceutical sciences
Introduction to Drug Discovery and Development.

Introduction :-

  • 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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