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Msg  166927 of 171667  at  8/9/2022 7:20:54 PM  by

ZFP


 In response to msg 166925 by  rynotheknife
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Re: Pipeline leverage

Consistent as always. KISS by counting boxes rather than reading what they say.

Lots of good articles on what is required prior to preclinical stages and articles and FDA guidance on what occurs during preclinical studies - all prior to an IND submission which is in fact the answer to why they are considered preclinical and have not yet filed an IND

In vitro and in vivo activities.
Studies include
animal testing and modeling
in vitro research
Formulation analysis
Bioanalysis
Immunogenicity testing
safety pharmacology
Synthesis
Toxicology
Product characterization
Absorption, distribution metabolism and excretion (ADME)
Pharmacokinetics (PK) and pharmacodynamics (PD)
Analytical Method development to formalize assays to measure potency, purity etc

This can take 1-2 years so building the portfolio prior to lead PoC is pretty useful.


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