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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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Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
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Drug Clearance: Overview01:06

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Drug elimination refers to drug removal from the body, either through urine or bile, by the kidneys or liver, respectively. A pharmacokinetic parameter, drug clearance, measures the efficiency of drug removal from the bloodstream within a specific time frame. It is calculated as the rate at which a drug is eliminated from plasma divided by the drug's concentration in plasma.
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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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The selection of a drug's delivery route depends upon its physicochemical properties, including lipid or water solubility and ionization, as well as the therapeutic requirement, such as immediate or sustained effect. These routes can be divided into three primary categories: enteral, parenteral, and topical.
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Related Experiment Video

Updated: Jul 30, 2025

An Organotypic High Throughput System for Characterization of Drug Sensitivity of Primary Multiple Myeloma Cells
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Structured content and data management-enhancing acceleration in drug development through efficiency in data

Jill Beierle1, Marquerita Algorri1, Marisol Cortés2

  • 1Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA.

AAPS Open
|May 16, 2023
PubMed
Summary
This summary is machine-generated.

Expedited regulatory pathways accelerate innovative drug approvals but challenge CMC data. Structured Content and Data Management (SCDM) offers technological solutions to streamline regulatory filings and improve data usability.

Keywords:
Acceleration pathwayAutomationChemistry manufacturing and controlsCloud-based systemsRegulatory scienceStabilityStandardsStructureStructured content data management

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Area of Science:

  • Pharmaceutical regulatory science
  • Drug development and manufacturing

Background:

  • Innovative therapeutics are crucial for unmet medical needs, driving the adoption of expedited regulatory pathways.
  • Expedited reviews, while beneficial, create challenges for Chemistry, Manufacturing, and Controls (CMC) data management in submissions.
  • Current regulatory filing systems face inefficiencies, particularly under condensed timelines.

Purpose of the Study:

  • To highlight technological advancements addressing inefficiencies in the regulatory filing ecosystem.
  • To emphasize Structured Content and Data Management (SCDM) as a foundational solution.
  • To explore the potential of IT infrastructure re-mapping for improved data usability.

Main Methods:

  • Review of current regulatory filing challenges and technological solutions.
  • Emphasis on Structured Content and Data Management (SCDM) principles.
  • Discussion of transitioning from document-based to electronic data libraries.

Main Results:

  • SCDM provides a framework for technologies that streamline data usage for sponsors and regulators.
  • Re-mapping IT infrastructure enhances data usability by shifting to electronic data libraries.
  • Technological advances can mitigate inefficiencies in regulatory submissions.

Conclusions:

  • SCDM adoption can ease the burden on sponsors and regulators by optimizing data management.
  • Transitioning to electronic data libraries improves data usability and submission efficiency.
  • Widespread SCDM adoption is expected to enhance overall speed and efficiency in regulatory compilation and review.