Formulation Development Lesson on Human Data Relevance

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UpscaleFermium
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10 Questions

In vitro testing can be used to replace animal experiments in formulation development.

True

The purpose of an assay is to predict toxicity of new orally inhaled drugs.

False

Assay validation is not necessary when using in vitro testing methods.

False

Fixed concentration procedure is used in acute inhalation toxicity testing.

True

The purpose of an assay is solely to predict bioavailability data.

False

Sub-chronic inhalation assessments are used to evaluate the toxicity of a substance after acute exposure.

True

In vitro testing methods are less efficient than animal experiments in formulation development.

False

The LC50 toxicity test is a measure of evident toxicity.

True

Guidelines and standards are not necessary when using in vitro testing methods.

False

The relevance of an assay is determined by its ability to predict human data, defined by its purpose.

True

Learn about formulation development with a focus on the relevance of human data, including examples related to bioavailability, psoriasis, and the lungs. Explore how non-toxic concentrations might differ from FDA-approved levels and the challenges with GHS classification.

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