Nonclinical overview and summaries, drafted from your study reports.
Asthra reads your pharmacology, pharmacokinetic and toxicology reports and drafts the CTD 2.4 nonclinical overview and the 2.6 written and tabulated summaries. Every NOAEL, exposure value and finding is cited to the report it came from, so your toxicologist spends time on interpretation, not retyping tables.
What Asthra reads.
Pharmacology reports
Primary and secondary pharmacodynamics and safety pharmacology studies.
Pharmacokinetic reports
Absorption, distribution, metabolism, excretion and toxicokinetic data.
Toxicology reports
Single and repeat-dose toxicity, genotoxicity, and reproductive and other studies, GLP and non-GLP.
Investigator's Brochure
So the summaries and the IB tell the same story about the nonclinical programme.
Proposed clinical dose
From the protocol or synopsis, for exposure margins and the starting-dose rationale.
Regulator advice
Pre-IND or scientific-advice minutes on the nonclinical package, where you have them.
From study reports
to cited summaries.
Load the study reports
Asthra classifies each report by discipline and study type and lists anything the summaries will need that is missing.
Build the tabulated summaries
Study-by-study tables for pharmacology, pharmacokinetics and toxicology, with each cell cited to its report.
Draft the written summaries and overview
2.6 written summaries from the tables, then the 2.4 overview that interprets the programme against the proposed clinical use.
Toxicologist review
Your nonclinical lead reviews in Word or the web app, chats with Asthra to reword an interpretation or add a study, and approves each change.
Filing an IND? The nonclinical summaries sit alongside the cover letter, general plan and Phase 1 CMC on our IND authoring page. For background, see CTD Modules 1 to 5 explained.
Common questions on AI-assisted nonclinical summaries.
What does a nonclinical summary AI writing tool do?+
It reads your nonclinical study reports and drafts the summaries a regulator reads first: the 2.4 nonclinical overview, which interprets the programme, and the 2.6 written and tabulated summaries, which set out the pharmacology, pharmacokinetics and toxicology study by study. Asthra builds the tabulated summaries from the reports and cites every number and finding back to its source.
Which sections does Asthra draft?+
The 2.4 nonclinical overview and the 2.6 written and tabulated summaries: 2.6.1 introduction, 2.6.2 and 2.6.3 pharmacology, 2.6.4 and 2.6.5 pharmacokinetics, and 2.6.6 and 2.6.7 toxicology, following ICH M4S. These are drafted today as part of an IND.
Does Asthra write the nonclinical study reports themselves?+
No. The study reports come from your CRO or in-house lab. Asthra summarises and interprets them for the submission.
How does it handle margins of exposure and NOAELs?+
Values such as NOAELs, exposure (AUC and Cmax) and safety margins are taken from the study reports and cited at the table cell. Where a margin depends on the proposed clinical dose, Asthra flags it for your toxicologist to confirm rather than presenting it as settled.
Can I use the same summaries later in the NDA or BLA?+
Yes. Module 2 summaries for a marketing application are a separate document type, and Asthra can update the IND versions as new studies complete instead of starting again.
From the blog
- Before a New Testing Method Goes into a Submission, Write Down Exactly What It Supports
In September FDA published a direct final rule replacing 'animal' with 'nonclinical' in parts of its regulations, and EMA opened a voluntary pilot for discussing data from new approach methodologies. Neither says a particular method is enough for a particular decision. That work falls to the sponsor, the CRO that developed the method and the writer who has to state the claim precisely and keep its limits attached.
- One Molecule, Many Indications: Retatrutide and the Writing-Org Problem Sponsors Aren't Sized For
Retatrutide's Phase 3 obesity readout is the headline. The operating story is the program shape — one molecule running pivotal trials across obesity, T2D, OSA, MASH, cardiovascular outcomes and knee osteoarthritis, with the GLP class expanding into more indications behind it. That is not a hiring problem. It is a writing-architecture problem.
- FDA's Drug Repurposing RFI: Why This Is a Regulatory Writing Opportunity
The FDA opened a docket on May 13 asking for drug repurposing candidates — explicitly inviting AI/ML preclinical evidence. Comments are due through June 29. The window matters more than the form.
What it costs, and how long it takes.
IND nonclinical summaries (2.4 and 2.6)
CTD Module 2 summaries
Outsourced figures are typical industry ranges, not quotes. How we estimate them.
Draft your nonclinical
summaries first.
Load the study reports you have, get cited 2.4 and 2.6 drafts, and judge them on your own programme.