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Drug Discovery: Overview01:26

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that the same...
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Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
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Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

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The year's new drugs.

Ann I Graul1

  • 1Prous Science, Barcelona, Spain. agraul@prous.com

Drug News & Perspectives
|March 3, 2004
PubMed
Summary

In 2003, 30 new molecular entities and biologic drugs and two diagnostic agents were launched globally. The Endocrine and Metabolic Drugs therapeutic group led new product introductions, with the United States as the primary market.

Area of Science:

  • Pharmacology and Therapeutics
  • Drug Discovery and Development
  • Health Economics and Outcomes Research

Background:

  • This annual review tracks new molecular entities and biologic drugs launched globally.
  • The article provides a historical and research-based perspective on recent pharmaceutical innovations.
  • It serves as a benchmark for drug development and market access trends.

Purpose of the Study:

  • To document and analyze new molecular entities and biologic drugs first marketed in 2003.
  • To identify key therapeutic areas and geographical markets for new drug launches.
  • To provide insights into the landscape of pharmaceutical innovation and market penetration.

Main Methods:

  • Data collection on new drug approvals and market launches worldwide for 2003.

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  • Categorization of new products by therapeutic class and country of first market introduction.
  • Analysis of market dynamics and trends based on launch data.
  • Main Results:

    • 30 new chemical entities and biologic drugs, plus two diagnostic agents, reached their first markets in 2003.
    • An additional six products were approved in 2003 but launched subsequently.
    • Endocrine and Metabolic Drugs was the leading therapeutic group with six new launches.
    • The United States led in new product launches, accounting for 20 introductions (66.6% of total).

    Conclusions:

    • The year 2003 saw significant activity in new drug development and market entry.
    • The Endocrine and Metabolic therapeutic area was a key focus for pharmaceutical companies.
    • The United States remains a dominant market for the launch of novel therapeutics.