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
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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