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Questions and Answers
The release of Formulation 1 is faster than Formulation 3.
True
The plasma concentration of 2 µg/ml is measured at 12 hours in vivo.
False
The dissolution model is used to predict the release time of drugs in the lungs.
False
At least 5 different responses are required for demonstrating prediction according to Level C.
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Formulation 2 has the highest cmax value compared to Formulation 1 and Formulation 3.
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The time until 50% dissolution is 70 minutes in an in vitro model.
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The purpose of the psoriasis study is to improve the current therapeutics.
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The animal model used for the psoriasis study looks exactly like human skin.
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The study aims to understand the mechanisms behind the clinical data.
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The idea of stimulating with pre-activated T-cells is not considered in the study.
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Known therapeutics are used in the study to demonstrate irrelevance.
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A non-toxic concentration of an excipient is always lower than the FDA approved concentration.
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GHS classification is a reliable method for determining the toxicity of excipients.
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The relevance of an assay is determined by its ability to predict human data.
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Good Manufacturing Practice (GMP) focuses on assay quality and standardization.
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There is always a guideline available for assay development.
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Assay validation is not a part of the assay description in context of quality standards.
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REACH is relevant to the registration of chemicals
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Assay validation is dependent on the purpose of the assay
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The throughput of an assay is solely determined by its cost
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Alternative methods can be used in place of animal experiments
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Human co-culture is a type of assay validation
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The quality of an assay is determined by its ability to predict human data
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The article states that the correlation between dead lung cells and the LD50 is that half of the animals are dead.
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The lungs are classified as Class 1 in the context of the article.
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The article discusses the comparison between in vivo and in vitro acute respiratory toxicity.
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The IC50 concentration of 0.1% is classified as Class 1 according to the article.
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The article mentions the MTT cell viability data in relation to lung in vitro testing.
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The article provides information about the FDA approval for lung-related treatments.
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Study Notes
Pharmacokinetics and Bioavailability
- Plasmakonzentration is the concentration of a substance in the plasma, measured in µg/ml.
- The Bateman function is used to model in vivo plasma concentration.
- Key pharmacokinetic parameters include Cmax, tmax, and AUC.
In Vitro and In Vivo Correlation
- In vitro dissolution testing is used to predict in vivo plasma concentration.
- At least three different responses for both in vitro and in vivo conditions are required for three formulations.
- Point-to-point correlation (Level C) is used to demonstrate prediction of cmax.
Relevance of Assays
- The purpose of an assay is to predict human data.
- Assay description is critical in the context of quality standards.
- Guidelines and quality systems include OECD, FDA, USP, EMA, GMP, and GLP.
- Throughput is a critical consideration in assay development.
Case Studies
- Example 1: Bioavailability
- Example 2: Psoriasis
- The goal is to predict the efficacy of new therapeutics.
- The mechanism behind clinical data must be understood.
- Known therapeutics can be used to demonstrate relevance.
- Example 3: The lungs
- The goal is to develop efficient formulations.
- In vitro and in vivo correlations are critical.
Guidelines and Standards
- Guidelines and standards are critical for assay development.
- Case 1: Guideline available (e.g., OECD, FDA, USP, EMA).
- Case 2: No guideline available, requires data basis and identification of methods.
GMP and GLP
- GMP (Good Manufacturing Practice) focuses on product quality and is important for pharmaceutical production.
- GLP (Good Laboratory Practice) focuses on assay quality and standardization and is important for registration, evaluation, and restriction of chemicals.
Risks and Changes
- Implementing basic ideas in study planning is critical.
- Considerations include study plan, work report, time schedule, project evaluation, and archive.
Summary
- The goal is to replace animal experiments with alternative methods.
- Relevance of an assay is critical for predicting human data.
- Assay description, quality standards, and throughput are critical considerations.
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Description
Test your knowledge on pharmacokinetics with questions related to Cmax, Tmax, AUC calculations, in vivo and in vitro experiments, and drug release percentages over time. Make sure to provide at least 3 different responses for each condition and formulation.
