Cmc

Phase I Study Design

Best achievable

Rodent model:

Rodent: NOAEL

Dog half-life >8h;

API stable for at

Cohorts of healthy

(enhance

ED90<0.3mg/kg;

>50 mg/kg; dog:

dog BA >90%; no

least 6mo Cost of

normal subjects:

investment)

human recep

NOAEL >50 mg/kg; no

active metabolites;

goods for API

staggered (SD to

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

Get My Free Ebook


Post a comment