Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials

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Chapter: Pharmacovigilance: Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials

Non-clinical safety evaluation plays a key part in the development of novel pharmaceutical products, and the requirement for this can, in part, be attributed to drug-induced toxicities and serious adverse reactions.


Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials

INTRODUCTION

Non-clinical safety evaluation plays a key part in the development of novel pharmaceutical products, and the requirement for this can, in part, be attributed to drug-induced toxicities and serious adverse reactions. Governments worldwide legislate to protect the population against unsafe medicines, and much of the legislation has been enacted as a result of disasters caused by serious adverse reactions to medicinal prod-ucts such as thalidomide. The resulting regulations allow governments to exercise control over medici-nal products by compelling pharmaceutical companies to obtain authorisation to market their products. The effect is that, in the major pharmaceutical markets of the world, Sponsor companies are required to submit data demonstrating the quality, safety and efficacy of medicinal products to regulatory bodies which, subject to a positive review of the data, will grant a marketing authorisation or licence for the product.

The non-clinical safety data presented in such applications are gathered predominantly in the early stages of product development for use in assessing product safety prior to administration to humans in clinical trials. The aims of the non-clinical studies include

·     Identification of target organ toxicities

·     Identification of dose–response relationships

·     Assessment of systemic exposure and relationship with pharmacological and toxicological responses

·     Assessment of reversibility of effect

·     Provision of a basis for assessment of safe starting dose for human trials

·     Identification of parameters for safety monitoring in human trials.

In summary, the non-clinical studies aim to build a profile of the potential effects of the product on humans, allowing the trials to be designed with an appropriate dose regimen and with safety monitor-ing to allow early detection of potential target organ toxicities.

 

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