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[Pharmaceutical technology: development and research]

M Traisnel

    Bulletin De L'Academie Nationale De Medecine
    |June 1, 1994
    PubMed
    Summary

    Pharmaceutical manufacturing involves the bulk production of medicine ingredients and their preparation into dosage forms, adhering to Good Manufacturing Practices (GMP). This process integrates research, development, training, and regulatory compliance for patient safety and drug efficacy.

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    Area of Science:

    • Pharmaceutical Sciences
    • Chemical Engineering
    • Drug Development

    Context:

    • Pharmaceutical manufacturing differs significantly from consumer goods production.
    • It encompasses the bulk synthesis of active pharmaceutical ingredients (APIs) and excipients.
    • Manufacturing involves precise formulation, mixing, and packaging into final dosage forms.

    Purpose:

    • To outline the distinct nature of pharmaceutical manufacturing.
    • To highlight the integration of research and development (R&D) with production.
    • To emphasize the critical role of Good Manufacturing Practices (GMP) in ensuring product quality and patient safety.

    Summary:

    • Pharmaceutical manufacturing is the scientific study and large-scale production of medicinal ingredients.
    • The process includes formulation, preparation, and packaging into patient-ready dosage forms under strict GMP guidelines.
    • Key concepts like bioavailability, drug targeting, and patient compliance are integral to pharmaceutical development and manufacturing.

    Impact:

    • Establishes a clear distinction between pharmaceutical and general manufacturing sectors.
    • Underscores the continuous chain from R&D to final product delivery.
    • Highlights the importance of regulatory adherence and scientific principles in producing safe and effective medicines.

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