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Related Concept Videos

In Vitro Drug Release Testing: Overview, Development and Validation01:10

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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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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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Recommended Guidelines for Developing, Qualifying, and Implementing Complex In Vitro Models (CIVMs) for Drug

Jason E Ekert1, Julianna Deakyne1, Philippa Pribul-Allen2

  • 1In Vitro In Vivo Translation, Research, Pharmaceutical R&D, GlaxoSmithKline, Collegeville, PA, USA.

SLAS Discovery : Advancing Life Sciences R & D
|June 5, 2020
PubMed
Summary

Complex in vitro models (CIVMs) are crucial for improving early drug discovery. These advanced models enhance safety, pharmacology, and efficacy assessments, reducing costly late-stage failures in pharmaceutical R&D.

Keywords:
3D bioprinting3D cell culturecomplex in vitro modelefficacyfunctional genomicsmicrophysiological systemsorganoidssafetyscreeningspheroid

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Area of Science:

  • Pharmaceutical research and development
  • Drug discovery and development
  • Biomedical engineering

Background:

  • High research and development (R&D) costs and low success rates plague the pharmaceutical industry.
  • Existing cellular models often fail to accurately represent human physiology or disease states.
  • There is a critical need for more predictive models in early drug discovery to reduce attrition.

Purpose of the Study:

  • To provide a perspective on the development and implementation of complex in vitro models (CIVMs) in early drug discovery.
  • To outline key considerations for qualifying CIVMs for various drug discovery applications.
  • To highlight the future integration of CIVMs with computational modeling and AI/ML.

Main Methods:

  • Discussion of early drug discovery stages: target identification, hit/lead discovery, lead optimization, and preclinical safety.
  • Analysis of critical aspects for CIVM development and qualification, including cell types, platforms, throughput, and endpoints.
  • Review of the application of CIVMs in drug discovery and translational research.

Main Results:

  • CIVMs offer a more physiologically relevant approach compared to simplistic cellular models.
  • Successful implementation requires careful consideration of model design, cell sources, and assay development.
  • Qualification ensures CIVMs are suitable for specific drug discovery contexts and translational research.

Conclusions:

  • Adoption of CIVMs represents a paradigm shift, moving costly failures to earlier, less expensive stages of drug discovery.
  • Adequately qualified CIVMs are essential for accurate safety, pharmacology, and efficacy predictions.
  • Future drug discovery will likely involve synergistic integration of CIVMs with computational modeling and AI/ML.