Readiness Scorecard
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Critical Gaps
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Data-Driven IND Checker
Check your IND against 20 evidence-based rules derived from published clinical hold data (8.9% hold rate, n=1,410 CDER INDs). Includes hold statistics dashboard, risk scoring, and specific remediation guidance.
Open IND Readiness Checker →Starting Dose Calculator (NOAEL to MRSD)
Calculate the Maximum Recommended Starting Dose (MRSD) for first-in-human studies using FDA body surface area (BSA) scaling from animal NOAEL data.
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HED (mg/kg)
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MRSD (mg/kg)
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MRSD (mg total, 60 kg)
Note for biologics: For biologic products, the Minimum Anticipated Biological Effect Level (MABEL) approach may be more appropriate than NOAEL-based scaling, particularly for immunomodulatory agents. Consult FDA Guidance on dose selection for biologics.
BSA Conversion Reference (FDA Guidance)
| Species | Ref. Weight (kg) | Km | Conversion Factor (divide NOAEL by) |
|---|---|---|---|
| Mouse | 0.02 | 3 | 12.3 |
| Rat | 0.15 | 6 | 6.2 |
| Rabbit | 1.8 | 12 | 3.1 |
| Dog | 10 | 20 | 1.8 |
| Monkey | 3 | 12 | 3.1 |
| Mini-pig | 20 | 27 | 1.4 |
| Human | 60 | 37 | — |
Pre-IND Timeline Generator
Estimate your path from current stage to IND submission. Timelines vary significantly based on molecule complexity, regulatory interactions, and organizational readiness.
Disclaimer: These timelines are estimates based on typical industry benchmarks. Actual timelines vary significantly based on molecule complexity, manufacturing readiness, regulatory interactions, and internal resources. Cell and gene therapies may require additional specialized regulatory considerations.
FDA Guidance Documents for Pre-IND Planning
Key FDA guidance documents relevant to IND preparation and first-in-human studies. Download PDFs for offline reference.
Meetings
Formal Meetings Between FDA and Sponsors
Meeting types, procedures, timelines, and best practices for productive FDA interactions.
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IND Content
Content & Format of INDs for Phase 1
What FDA expects in your initial IND filing, including required sections and formatting standards.
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Meetings
IND Meetings: CMC Information
CMC data expectations at each stage of IND development and regulatory review.
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Nonclinical
ICH M3(R2) Nonclinical Safety
International nonclinical study requirements for the conduct of human clinical trials.
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Regulatory
Exploratory IND Studies
Reduced requirements for Phase 0 exploratory studies and microdosing approaches.
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Dose
Optimizing Dosage (Project Optimus)
FDA dose optimization framework for oncology and beyond.
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Regulatory
INDs by Sponsor-Investigators
Sponsor-investigator responsibilities, requirements, and regulatory expectations.
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