|
|
![]() |
![]() ![]() |
![]() |
|
||
![]() |
![]() |
Re: Pipeline leverageConsistent 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. |
![]() ![]() ![]() ![]() |
return to message board, top of board |