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Related Concept Videos

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

In Vitro Drug Release Testing: Overview, Development and Validation

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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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In Vitro Drug Dissolution: Alternative Methods01:17

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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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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In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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In-vitro Mutagenesis01:16

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To learn more about the function of a gene, researchers can observe what happens when the gene is inactivated or “knocked out,” by creating genetically engineered knockout animals. Knockout mice have been particularly useful as models for human diseases such as cancer, Parkinson’s disease, and diabetes.
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Mutagenicity and carcinogenicity refer to the ability of drugs to cause genetic defects and induce cancer, respectively. The International Agency for Research on Cancer (IARC) classifies agents into four groups based on their carcinogenic potential. Group 1 agents are known human carcinogens; group 2A agents are probably carcinogenic to humans; group 3 agents lack data to support their role in carcinogenesis; and group 4 includes agents for which data support that they are not likely to be...
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Resources for Developing Reliable and Reproducible In Vitro Toxicological Test Methods.

Elijah J Petersen1, Vytautas Reipa1, Menghang Xia2

  • 1Biosystems and Biomaterials Division, Material Measurement Laboratory, National Institute of Standards and Technology (NIST), 100 Bureau Drive, Gaithersburg, Maryland 20899, United States.

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Summary

New resources and tools enhance the reliability and reproducibility of in vitro toxicological testing. These advancements offer advantages over traditional in vivo methods.

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Area of Science:

  • Toxicology
  • Biotechnology
  • Laboratory Science

Background:

  • In vitro test methods offer potential advantages over in vivo studies.
  • Developing reliable and reproducible in vitro assays is crucial for toxicological assessments.

Purpose of the Study:

  • To describe key resources and tools for improving in vitro test methods.
  • To enhance the reliability and reproducibility of toxicological testing.

Main Methods:

  • Literature review of existing resources and tools.
  • Description of methodologies for in vitro assay validation.

Main Results:

  • Identification of key resources and tools.
  • Demonstration of methods to improve assay consistency.

Conclusions:

  • Available resources and tools can significantly enhance in vitro toxicology.
  • Increased reliability and reproducibility of in vitro methods are achievable.