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Related Concept Videos

Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Key issues in the pharmaceutical industry: consequences on R&D.

Nafees N Malik1

  • 1University of Cambridge, Institute of Biotechnology, Tennis Court Road, Cambridge, CB2 1QT, UK nafees_malik@hotmail.com.

Expert Opinion on Drug Discovery
|March 14, 2013
PubMed
Summary

Drug discovery faces increasing challenges, impacting pharmaceutical companies. This article explores R&D issues and suggests strategies for success in pharmaceutical innovation.

Area of Science:

  • Pharmaceutical Science
  • Drug Development
  • Healthcare Economics

Background:

  • Drug discovery is increasingly complex due to scientific, financial, and political factors.
  • Rising research and development (R&D) costs and declining new drug approvals challenge the pharmaceutical industry.
  • Patent expirations, generic competition, and decreased public/investor confidence further complicate the landscape.

Purpose of the Study:

  • To discuss the critical issues confronting pharmaceutical companies.
  • To analyze the implications of these challenges on the drug research and development (R&D) process.
  • To propose strategic changes for pharmaceutical R&D to ensure future success.

Main Methods:

  • Qualitative analysis of industry trends.

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  • Review of economic and regulatory factors impacting drug development.
  • Synthesis of challenges and strategic recommendations for R&D.
  • Main Results:

    • Pharmaceutical R&D is hampered by escalating costs, stringent regulatory standards (e.g., FDA), and patent cliffs.
    • Industry faced declining public and investor confidence due to pricing, safety, and trial failures.
    • Significant shifts in R&D strategy are necessary for pharmaceutical companies to navigate these hurdles.

    Conclusions:

    • Pharmaceutical companies must adapt R&D strategies to overcome escalating costs and regulatory hurdles.
    • Innovation in drug discovery requires addressing economic, political, and scientific complexities.
    • Strategic adjustments are crucial for maintaining industry viability and public trust.