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PRECLINICAL DEVELOPMENT STRATEGY
Preclinical studies (ADME, safety
pharmacology and toxicology) are essential for the development of your product and
the regulatory submission of your dossier. For each drug project, a well-conceived
preclinical development strategy, focussed on your 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 development strategy for your
drug project, YOU will get:
- a preclinical development strategy
in compliance with your short-term and long-term project objectives and integrated
with your chemical, pharmaceutical, clinical and regulatory strategies;
- a preclinical development strategy
tailored to your existing data and the appropriate regulatory guidelines;
- a preclinical development strategy
with a clear rationale and objectives for the studies envisaged;
- a preclinical development strategy
allowing you to proceed to a satisfactory planning, an accurate budget and a successful
control of the potential constraints.
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