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PRECLINICAL STRATEGY
Toxicology, ADME, and safety pharmacology studies are essential for the development
of a medicinal product and the submission of a marketing authorization application.
For each drug project, a well-conceived preclinical development strategy, focussed
on the clients' specific needs, is the indispensable basis of a first-time-right
study program. A first-time-right approach results in the timely start of clinical
development phases, efficient dossier preparation and an uneventful review by regulatory
authorities.
By asking ADMERITOX to work out the preclinical strategy for a project, YOU
as the client may expect:
- a preclinical strategy in compliance
with the short-term and long-term project objectives and integrated with chemical,
pharmaceutical, clinical and regulatory strategies
- a strategy tailored to existing
data and the applicable regulatory guidelines
- clear rationales and objectives
for the studies envisaged
- a development plan allowing to
proceed to a satisfactory planning, an accurate budget and a successful control of
the potential constraints
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