Preclinical Safety: In Vitro to Human Dose Prediction

This module introduces the fundamental concepts of pharmacology and toxicology in the context of preclinical safety studies. It likely covers the basic principles of how drugs interact with biological systems and the potential toxic effects they may have.

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This module explores the timeline of preclinical safety studies in drug development. It probably covers the various stages of safety testing required before a drug can enter clinical trials, including the duration and sequence of different tests.

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This module examines historical cases where drugs caused unexpected harm, highlighting the importance of rigorous safety testing. It likely discusses specific incidents, their consequences, and how they shaped current safety regulations and practices.

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This module focuses on laboratory tests used to assess drug safety outside of living organisms. It probably covers various types of cell-based and biochemical assays used to screen for potential toxicity and other safety concerns early in drug development.

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This module delves into the specific safety concern of hERG channel inhibition, which can lead to cardiac arrhythmias. It likely explains the role of hERG channels in heart function, methods to test for hERG inhibition, and its implications for drug safety.

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This module explores the concept of on-target toxicity, where a drug's intended mechanism of action also causes adverse effects. It probably discusses strategies for identifying and mitigating on-target toxicity during drug development.

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This module covers animal-based safety studies, which are crucial for assessing a drug's toxicity in living systems. It likely discusses study design, animal models, dose selection, and interpretation of results from these preclinical trials.

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This module focuses on the potential for drugs to interact with each other, altering their efficacy or safety profiles. It probably covers mechanisms of drug interactions, methods for predicting and testing interactions, and their implications for drug development and use.

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This module examines the challenge of developing drugs that selectively target specific members of a protein family while avoiding others. It likely discusses strategies for achieving selectivity and methods for assessing off-target effects within protein families.

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This module explores the importance of drug purity in ensuring safety. It probably covers methods for assessing and maintaining drug purity, the potential impacts of impurities on safety, and regulatory requirements for drug purity.

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This module discusses the balance between a drug's therapeutic benefits and its potential risks. It likely covers approaches to weighing efficacy against safety concerns, decision-making processes in drug development, and regulatory considerations.

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This module focuses on determining the appropriate starting dose for first-in-human clinical trials. It probably covers methods for extrapolating from animal data to human doses, safety factors, and regulatory guidelines for dose selection.

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This module examines the unique safety considerations for drugs used in cancer treatment. It likely discusses the different risk-benefit calculations for oncology drugs, specific toxicity concerns, and approaches to safety assessment in this field.

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This module explores ongoing preclinical safety studies that occur alongside early clinical trials. It probably covers the types of studies conducted, how they inform clinical development, and strategies for integrating preclinical and clinical data.

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This module focuses on monitoring drug safety after market approval. It likely covers methods for collecting and analyzing real-world safety data, regulatory requirements for post-market surveillance, and strategies for identifying and responding to safety signals.

Skills you'll gain