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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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Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
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It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
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Applying Cheminformatics to Develop a Structure Searchable Database of Analytical Methods
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Building a drug development database: challenges in reliable data availability.

Céline Audibert1, Morgan Romine2, Alexis Caze1

  • 1a Deerfield Institute , Epalinges , Switzerland.

Drug Development and Industrial Pharmacy
|August 6, 2016
PubMed
Summary
This summary is machine-generated.

Data on Investigational New Drug (IND) application filing dates from public sources show considerable inconsistencies. This highlights challenges in compiling reliable drug development data for policy analysis.

Keywords:
Biomedical innovationFederal RegisterFood and Drug AdministrationInvestigational New Drugclinical trialsdrug development

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Area of Science:

  • Biomedical innovation
  • Drug development
  • Regulatory science

Background:

  • Effective policy and legislative efforts require thorough analysis of drug development and industry output.
  • Publicly-available databases are crucial for understanding the biomedical innovation process.

Purpose of the Study:

  • To test methods for compiling drug development data from public sources.
  • To explore challenges in data extraction, completeness, and reliability for building a public drug development database.
  • To collect Investigational New Drug (IND) application filing dates for New Molecular Entities (NMEs).

Main Methods:

  • Collected IND application filing dates for 587 NMEs approved between 1994 and 2014.
  • Utilized the U.S. Food and Drug Administration's (FDA) Drugs@FDA database and the Federal Register (FR).
  • Extracted approval date, IND number, IND date, and source of information when available.

Main Results:

  • An IND date was available for 75.8% (445/587) of NMEs.
  • Drugs@FDA provided 51.6% (303/587) of IND dates, while FR contributed 50.6% (297/587).
  • Over half (61.6%) of NMEs with available IND dates had multiple reported dates, indicating data inconsistencies.

Conclusions:

  • Significant inconsistencies exist in the availability and reporting of drug development data, specifically IND application filing dates from public sources.
  • These data quality issues pose challenges for accurate analysis and policy-making in biomedical innovation.
  • Further efforts are needed to refine data collection methods for reliable measurement of drug innovation impact.