In this QCast episode, Jullia and Tom explore SAD and MAD studies and why they play such a central role in early clinical development. They explain what single ascending dose and multiple ascending dose studies are designed to show, how they help teams build an early picture of safety, tolerability, and pharmacokinetics, and why their value depends on clear escalation rules, fast data review, and disciplined study execution.

Key Takeaways

• Understand SAD and MAD studies as core early-phase designs used to assess single-dose and repeat-dose effects in humans.
• Use these studies to guide early decisions on dose escalation, accumulation, tolerability, and later dose planning.
• Plan review processes and operational detail carefully, because timing, data flow, and clear decision rules are critical to generating usable results.

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📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
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About Quanticate

Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in:

• Clinical Data Capture & Management
• Biostatistics & Statistical Consultancy
• Statistical Programming & PK/PD Analysis
• Medical Writing & Pharmacovigilance
• Regulatory & Submission Support
• AI & Automation
• Post-Marketing Safety & Real-World Data

Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.