Hi Shivam,
The full title of this section is Summary of Data and Guidance for the Investigator, so this is your chance to bring everything together succinctly and persuade the reader why your product is ready for human trials.
Start with the pharmacological basis for why your drug would be suitable for your indication. Then briefly summarize the results of the non-clinical studies you've conducted, maybe a sentence a study. Provide a NOAEL if you have one. Calculate the margin of safety you have between the dose used in your safety toxicology studies and the proposed human dose.
Then you can have short subsections with recommendations for:
- Indications and usage (proposed indication and route of administration)
- Administration and dosage (you can say that the strength and frequency of dosing will be described in the clinical protocols)
- Contraindications
- Warnings and Precautions for Use
- Summary of Expected Adverse Events (just say that human testing has not yet started)
- Drug Interactions (can be a short theoretical discussion based on what you know about your drug's metabolism and any potential for inhibition or enhancement by other drugs that use the same pathways)
- Use in Special Populations (if you haven't done reproductive testing, say that you will exclude women who are pregnant or nursing from your clinical trials, and ask subjects to take contraceptive measures. Promise that details will be in the clinical protocol. If you haven't done pediatric studies, then promise not to conduct studies in children yet. Also geriatric subjects. Comment on whether subjects with renal or hepatic impairment would be excluded from your clinical studies.)
- Overdosage
- Storage and Handling Procedures (recommended temperature/humidity during shipment and storage; recommended shelf-life)
It doesn't have to be long at this stage. You will revise the document frequently as you continue your development.
Best of luck!
Karen
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Karen Long RAC
Vancouver BC
Canada
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Original Message:
Sent: 20-Apr-2020 03:14
From: Shivam Mishra
Subject: IB Based Upon Non clinical Studies Only
I am writing an IB for a drug which is currently in Nonclinical studies. No clinical studies ongoing but planned . What should I put for section 7 "Guidance for Investigator" and for the risk assessment. Would like to inform that this drug is under the same family as another which is currently being reviewed.
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Shivam Mishra
Québec QC
Canada
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