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FDA Approved Drugs: Changes to Approved Drugs01:26

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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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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Drugs exert their therapeutic effects by interacting with receptors, enzymes, or ion channels that are present throughout the human body. The strength and duration of the interaction between a drug and its target receptor are characterized by the selectivity and specificity of the drug. Selectivity refers to a drug's strong preference for its intended target over other targets. For instance, isoprenaline, a non-selective β-adrenergic agonist, interacts with both β1- and...
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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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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Target selection for FDA-approved medicines.

Michael S Kinch1, Denton Hoyer2, Eric Patridge2

  • 1Washington University in St Louis, St Louis, MO, USA.

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Summary

The biopharmaceutical industry develops new medicines by focusing on specific biological targets. Analysis of FDA-approved drugs shows a few target families dominate, with emerging trends towards novel targets reflecting deeper disease understanding.

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Area of Science:

  • Biopharmaceutical research and drug development.
  • Translational medicine and pharmacology.

Background:

  • The biopharmaceutical industry is crucial for translating basic science into new medicines.
  • Understanding the mechanistic basis of drug efficacy, particularly target selection, is key.

Purpose of the Study:

  • To analyze FDA-approved new molecular entities (NMEs) to understand target selection trends.
  • To identify key target families and their relationship to clinical applications and temporal dynamics.

Main Methods:

  • Comprehensive analysis of FDA-approved NMEs.
  • Assessment of the mechanistic basis of drug efficacy, focusing on target families.
  • Evaluation of targeting trends over time.

Main Results:

  • Three target families account for nearly half of all NME approvals.
  • The top ten target families represent over three-quarters of NME approvals.
  • Target families correlate with clinical applications, showing dynamic trends.

Conclusions:

  • Drug discovery is increasingly focusing on novel target families, likely due to advances in understanding disease etiology.
  • A balance between target-based and phenotypic approaches is recommended for drug discovery.