Developability Assessment
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Who Should Attend
This course is specifically designed for personnel in the
pharmaceutical and biotechnology industries and contract
research organizations (CROs) who are involved in drug
discovery and early drug development and who want to have a
better understanding of the approaches and techniques available
for discovery lead selection and optimization. Participants should
have some knowledge of drug discovery and development and
desire to learn more about how to logically design, conduct, and
interpret lead optimization experiments in order the select the
optimal compound for preclinical development. Drug discovery
and development scientists, managers, and project team leaders
will gain a detailed understanding of the types of developability
assessment research studies that can be conducted to determine
the drug-like attributes and potential demerits of a discovery lead
or group of leads.
Description
The content of this course will assist pharmaceutical,
biotechnology, and CRO researchers and managers in
understanding the requirements for a logical, well designed, and
successful developability assessment program. The various
types of lead optimization experiments, which include in vitro
and
in vivo
pharmacology, stability and solubility assessments, in vitro
drug metabolism and delivery, preliminary animal
pharmacokinetics, and in vitro
and acute toxicology, will be
described and discussed. Study designs and potential results,
with possible interpretations, from each of the study types will be
presented. Examples of developability assessment logic plans for
various types of drug discovery programs will be presented and a
workshop will provide participants with the opportunity to design
and discuss other logic plan types.