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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. Graul

    Drug News & Perspectives
    |April 5, 2003
    PubMed
    Summary

    In 2001, 36 new drugs and diagnostic agents launched, with anti-infectives leading therapeutic areas. The United States dominated new product introductions, accounting for 43% of the global market.

    Area of Science:

    • Pharmaceuticals and Therapeutics
    • Drug Discovery and Development
    • Market Analysis

    Background:

    • The pharmaceutical industry continuously introduces new chemical entities and biological drugs.
    • Diagnostic agents play a crucial role in modern healthcare.
    • Market dynamics significantly influence the accessibility and adoption of new medical products.

    Purpose of the Study:

    • To analyze the landscape of new drug and diagnostic agent market introductions in 2001.
    • To identify the leading therapeutic areas for new product launches.
    • To determine the key geographical markets for these introductions.

    Main Methods:

    • Data compilation of new chemical entities, biological drugs, and diagnostic agents reaching their first markets in 2001.

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  • Categorization of new products by therapeutic group.
  • Analysis of market penetration, focusing on geographical distribution.
  • Main Results:

    • Thirty-four new chemical entities/biological drugs and two diagnostic agents were introduced in 2001.
    • Anti-infective therapy was the most active therapeutic group with five new market introductions.
    • The United States was the leading market, with 15 new launches representing 43% of all new introductions.

    Conclusions:

    • The year 2001 saw significant activity in pharmaceutical and diagnostic product launches.
    • Anti-infectives emerged as a key focus area for new drug development.
    • The United States demonstrated a strong market presence for novel therapeutic and diagnostic agents.