Abstract
A REVIEW: NEW DRUG DISCOVERY AND DEVELOPMENT
Rutuja Santosh Desale* and Gayatri Avinash Bhere
ABSTRACT
Drug discovery is a systematic endeavor aimed at identifying compounds that possess therapeutic potential for the treatment and management of diseases. The journey from a conceptual idea to the market introduction of a drug is intricate and can span approximately 5 to 10 years, incurring costs around $1.7 billion. To define the pharmacological properties and toxicity profile of a new drug molecule, both pre-clinical and clinical studies are integral components of the research and development process. The development of a new drug must progress through multiple phases to ensure the creation of a safe and effective medicine that meets all regulatory standards. The drug discovery and development process initiates with the identification and validation of targets, followed by optimization, lead compound discovery, and preclinical animal testing. These stages are essential precursors to clinical trials and the evaluation of drug candidates in human subjects. Preclinical studies are crucial for assessing the efficacy of therapeutic drugs or strategies before advancing to clinical trials. The pharmaceutical industry’s development of generic drug products represents a scientific and technical approach within the drug discovery and development framework. Currently, pharmaceutical companies are increasingly focusing on the development of generic products, as this pathway typically requires less time and financial investment compared to that of innovator companies. This review aims to provide a comprehensive discussion of the drug design methodologies for newly discovered drugs from 2020 to 2024, emphasizing their pharmacokinetic and pharmacodynamic profiles, as well as in vitro and in vivo evaluations. Additionally, this article offers a concise overview of the new drug discovery and development processes, along with a brief explanation of the distinctions between innovator and generic drugs, including the steps involved in the generic drug development process.
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