Remember, every Friday deserves a NOAEL for meetings. Go break some eggs.

Your Weekly Briefing:

👀 Insights

Study Design Isn’t a Template. It’s a Strategy

Most nonclinical teams treat study design as a logistics question — pick a species, pick a route, pick a duration, hand it to a CRO. That's protocol development. Not study design.

Learn what strategic design actually looks like in this week's newsletter:

💭 Myths v. Realities

Myth: Following ICH guidance is enough to design a defensible nonclinical study.

Reality: ICH guidance defines the floor, not the ceiling. A study that checks every box can still get pushback at IND review if it doesn't answer a real scientific question. Compliant ≠ useful.

🔧 Tools

A strategic checklist for study design.

Study Design Guide

A practical companion to this week's piece. The questions to ask before approving any nonclinical protocol, plus a framework for evaluating CRO designs.

Toxicology Study Design Guide.pdf

Toxicology Study Design Guide.pdf

375.01 KBPDF File

🎓 Inside My Course

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The Complete Guide to Nonclinical Development is the curriculum I wish someone had handed me on day one of my career. Twelve modules covering the full nonclinical landscape — including Module 4 on study design, which goes into the depth this week's piece only previewed.

The free preview shows you exactly what's inside. The actual lessons, the format, the structure. No commitment, no credit card.

👇 Take a look and see if it matches where you are:

THE NONCLINICAL | Drug development made simple.

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