Remember, GLP doesn’t mean “Good Luck Pal” — but sometimes it feels that way. Go break some eggs.
Your Weekly Briefing:
👀 Insights
5 Traits of a Defensible IND Program
A "healthy" IND program isn't the same as a defensible one. Most programs look fine on a Gantt chart — on time, on budget, no findings flagged — and still get held at Pre-IND.
Here are the five traits that actually separate the two:
💭 Myths v. Realities
Myth: If FDA didn't push back on your nonclinical package at the pre-IND, you're cleared to file.
Reality: Pre-IND silence isn't endorsement. The Agency answers the questions you ask — gaps you didn't flag are still gaps. A clean pre-IND meeting means your questions were addressed, not that your program is bulletproof.
🔧 Tools
Model your human starting dose
Did you grab this week’s Human Starting Dose calculator?
Convert animal NOAELs to a Human Equivalent Dose, apply the safety factor, and land on a defensible starting dose for first-in-human. The math FDA expects, in one place.
🖼 The Full IND Picture
Want more of this? Module 9 covers it.
Starting dose math is one of the questions every IND package has to answer — and one of the easiest places to lose FDA's confidence. The Complete Guide to Nonclinical Development walks through it end-to-end in Module 9, alongside the rest of the regulatory strategy decisions sponsors face.
👇 See the lessons, for free, no credit card required:
P.S.
▶️ Did you know Nonclinical Academy has a YouTube? Check it out here.