Remember, the cheap study always finds a way to bill you twice. Go break some eggs.

Your Weekly Briefing:

👀 Insights

The Clinical Trial You Run, Is the One Your Tox Study Allows

Most founders think they design their Phase 1 trial when they write the clinical protocol.

They don't. The fence — how long you can dose, how high you can push, what you're allowed to claim — went up months earlier, in a tox study that wrapped before the protocol existed.

This week's piece breaks down the four study-design choices that quietly set your clinical borders, and what each one costs to get wrong.

Toxicology studies play a bigger part in designing clinical trials than you might think. Find out why on this week's edition of The Nonclinical.

💭 Myths v. Realities

Myth: GLP means good science.

Reality: GLP is a documentation standard, not a quality-of-science standard. It governs how you record and verify what you did — not whether the study was designed well. A perfectly GLP-compliant study with the wrong doses, wrong species, or wrong endpoints is still a useless study.

🔧 Tools

How long can you dose?

One page that turns ICH M3(R2) Table 1 into plain English — match your clinical dosing duration to the tox studies that unlock it, with the oncology (ICH S9) exception built in. Pin it before you scope your first repeat-dose study.

tox_duration_card.pdf

Tox Study Duration Card

3.93 KBPDF File

🤑 Executive tier now has a payment plan option!

If you’ve been wanting all the things the Executive tier has to offer — private Slack, monthly Office Hours, direct access to me — but have trouble with the cost, I’ve just opened a payment plan option.

$200/month for 5 payments. And you get it all from Day 1.

(still need help? reply to this email, I will work with you)

Get the Executive tier with 5 payments of $200/month. Check out the Free Preview today.

THE NONCLINICAL | Drug development made simple.

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