Getting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal

Brian Booth, PhD, director of the Division of Cancer Pharmacology 1 in the Office of Clinical Pharmacology (OCP), Office of Translational Science (OTS), discusses how various clinical pharmacology studies provide better understanding of dose optimization for different types of patients. Learn more at: https://www.fda.gov/drugs/news-events... --------------------  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.   Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected]   Phone - (301) 796-6707 I (866) 405-5367

Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations
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Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations

AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products
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AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products

FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine
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FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine

OTC Monograph Reform: OTC Sunscreen Drugs
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OTC Monograph Reform: OTC Sunscreen Drugs

AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations
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AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations

FDA Direct: The Power of Real-Time Clinical Trials
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FDA Direct: The Power of Real-Time Clinical Trials

Designing First-In-Human Trials for Small Molecules and Biologics
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Designing First-In-Human Trials for Small Molecules and Biologics

FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices
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FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices

Drug Master File (DMF) Submissions on New FDA Form 3938
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Drug Master File (DMF) Submissions on New FDA Form 3938

Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims
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Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims

FDA Direct: FDA is Not Your Doctor - Discussing FDA's Role and Mandate
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FDA Direct: FDA is Not Your Doctor - Discussing FDA's Role and Mandate

Getting to First-in-Human for Small Molecules and Biologics
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Getting to First-in-Human for Small Molecules and Biologics

Advancing Real-Time Clinical Trials
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Advancing Real-Time Clinical Trials

Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
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Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing

AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice
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AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice

OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
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OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products

AGDD 2025 | D1S01 - Product-Specific Guidance for Complex Products: From Research to Standards
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AGDD 2025 | D1S01 - Product-Specific Guidance for Complex Products: From Research to Standards

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
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FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

Conversations on Cancer: Patient first = Project Facilitate
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Conversations on Cancer: Patient first = Project Facilitate

FDA Grand Rounds - Pharmacovigilance in Practice: From Safety Signals to Regulatory Action
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FDA Grand Rounds - Pharmacovigilance in Practice: From Safety Signals to Regulatory Action