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NIH Principles of Clinical Pharmacology

NIH Clinical Center via YouTube

Overview

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Explore the fundamentals of clinical pharmacology through this comprehensive lecture series that covers rational drug development and utilization in therapeutics as a translational scientific discipline. Master core pharmacokinetic and pharmacodynamic concepts including drug absorption, bioavailability, multicompartmental modeling, and population pharmacokinetics while examining the biochemical mechanisms underlying drug toxicity and therapeutic protein pharmacology. Delve into critical pathways of drug metabolism, membrane transport systems, and P-glycoprotein-mediated drug interactions, with special focus on transport across the blood-brain barrier. Analyze pharmacokinetic considerations across diverse patient populations including those with renal impairment requiring hemodialysis or renal replacement therapy, pregnant and nursing women, pediatric patients, geriatric populations, and obese individuals. Investigate advanced topics in pharmacogenomics, pharmacometabolomics, and dose modifications based on genetic research, while exploring clinical drug interactions and adverse drug reaction assessment. Examine cutting-edge developments in drug discovery through quantitative systems pharmacology, computational methods, combinatorial screening, and natural products research. Study drug formulation and delivery systems, biologics development considerations, and FDA approval processes, alongside specialized areas including immunotherapeutics, T-cell therapies, and positron emission tomography applications in pharmacokinetics. Apply theoretical knowledge through practical case studies covering mass spectrometry applications, protein drug pharmacokinetics, transporter-mediated interactions, population modeling exercises, and immunotherapy-related adverse events, while addressing ethical considerations in both pediatric and adult clinical pharmacology research and practice.

Syllabus

Introduction to Module 1 with Dr. Craig Thomas
Introduction to Clinical Pharmacology and Therapeutics - Part 1: Overview of Clinical Pharmacology
Introduction to Clinical Pharmacology and Therapeutics - Part 2: Pharmacokinetic Concepts
Introduction to Pharmacology, Drug Development and Clinical Pharmacology with Dr. William D. Figg
Practical Pharmacology with Dr. Anne Zajicek
Biochemical Mechanisms for Drug Toxicity with Dr. A. Beasley Green
Ethics in Pediatric Clinical Pharmacology with Dr. Donna L. Snyder
Ethics in Adult Clinical Pharmacology with Dr. Ezekiel J. Emanuel
Introduction to Module 2 with Dr. Anne Zajicek
Drug Absorption and Bio-availability with Dr. Jan Beumer
Multicompartmental Pharmacokinetic Modeling with Dr. Scott R. Penzak
Noncompartmental vs. Compartmental Approaches to Pharmacokinetic Analysis with Dr. Paolo Vicini
Population Pharmacokinetics with Dr. Robert R. Bies
Chemical Analysis of Drugs and Metabolites with Dr. Andrew Goey
Pharmacokinetics/Pharmacodynamics of Protein Drugs with Dr. Jürgen Venitz
Pharmacokinetics & Pharmacodynamics of Therapeutic Proteins Part 1 of 5 with Dr. Bernd Meibohm
Pharmacokinetics & Pharmacodynamics of Therapeutic Proteins Part 2 of 5 with Dr. Bernd Meibohm
Pharmacokinetics & Pharmacodynamics of Therapeutic Proteins Part 3 of 5 with Dr. Bernd Meibohm
Pharmacokinetics & Pharmacodynamics of Therapeutic Proteins Part 4 of 5 with Dr. Bernd Meibohm
Pharmacokinetics & Pharmacodynamics of Therapeutic Proteins Part 5 of 5 with Dr. Bernd Meibohm
Introduction to Module 3 with Dr. Lisa M. Cordes
Pathways of Drug Metabolism Part 1 of 2 with Dr. Kenneth Thummel
Pathways of Drug Metabolism Part 2 of 2 with Dr. Deanna Kroetz
P-Glycoprotein and Drug Transport: Case Study with Jomy George
Membrane Transport with Dr. Kathy Giacomini
Drug Transport Across the Blood Brain Barrier with Dr. Sadhana Jackson
Introduction to Module 4 with Dr. Bruce Waldrop
Pharmacokinetic Considerations in Patients with Renal Impairment Part 1 of 3 with Dr. Darren Roberts
Pharmacokinetic Considerations in Patients with Renal Impairment Part 2 of 3 with Dr. Darren Roberts
Pharmacokinetic Considerations in Patients with Renal Impairment Part 3 of 3 with Dr. Darren Roberts
Pharmacokinetics in Patients Requiring Hemodialysis with Dr. Arthur Atkinson
Pharmacokinetics in Patients Requiring Renal Replacement Therapy Part 2 of 2 with Dr. Gregory Susla
The Liver and Drugs with Dr. Jürgen Venitz
Drug Therapy in Pregnant and Nursing Women with Dr. Anne Zajicek
Developmental and Pediatric Pharmacology with Dr. John N. van den Anker
Drug Therapy in the Geriatric Population with Dr. Darrell R. Abernethy
Pharmacokinetics and Obesity with Dr. Manjunath Pai
Introduction to Module 5 with Dr. Terry Seaton
Biomarkers of Drug Effects of Dr. Robert Schuck
Pharmacodynamic and Pharmacokinetic Modeling of Data with Dr. Joga Gobburu
Disease Progression Models with Dr. Diane Mould
Role of Pharmacodynamics in Drug Development with Dr. James Doroshow
Introduction to Module 6 with Dr. William Zamboni
Drug Discovery with Dr. Edward Sausville
Quantitative Systems Pharmacology with Dr. D. Lansing Taylor
Computational Methods of Drug Discovery and Design with Dr. Glen Kellogg
Combinatorial Drug Screening with Dr. Craig Thomas
Natural Products with Dr. Barry O'Keefe
Drug Formulation & Delivery with Dr. Robert Ternik
Considerations in the Development of Biologics with Dr. Mansoor Khan
Drug Development in the Pediatric Population with Dr. Anne Zajicek
Animal Scale Up and First-in-Human Studies with Dr. Jerry Collins
Dose Selection and Optimization in the Adult Population with Dr. Yaning Wang
Design of Clinical Drug Development Programs with Dr. Christopher D. Breder
FDA Approval Considerations with Dr. Paul Kluetz
Introduction to Module 7 with Dr. Elvin Price
Pharmacometabolomics: Implications for Clinical Pharmacology with Dr. Richard Weinshilboum
Pharmacogenomics with Dr. Michael Pacanowski
Dose Modifications Based on Pharmacogenomics Research with Dr. Howard McLeod
Clinical Pharmacogenomics Testing with Dr. Mary Relling
Clinical Drug Interactions with Dr. Sarah Robertson
Clinical Assessment of Adverse Drug Reactions with Dr. Christopher D. Breder
Post-Marketing Drug Safety Surveillance with Dr. Peter Waldron
Quality Assurance for Drug Therapy with Dr. Charles Daniels
Use of Positron Emission Tomography (PET) in Pharmacokinetics with Dr. Robert Innis
Enabling Technologies in Drug Formulation with Dr. Ping Gao
Immunotherapeutics with Dr. James Gulley
T-Cell Therapies: Principles and Practice with Dr. James Yang
Introduction to Mass Spectrometry: A Case Study with Dr. Robert Parise
PK/PD of Protein Drugs: A Case Study with Dr. Jürgen Venitz
"Victims & Perpetrators" in Therapeutics" Case Study with Dr. Lionel D. Lewis
Transporter Mediated Drug-Drug Interactions: A Case Study with Dr. Jomy M. George
PK/PD Modeling Exercise with Dr. Cody J. Peer
Discussion on Clinical Trial Endpoints with Dr. Barry Goldspiel
Immunotherapy-Related Adverse Events Case Study with Dr. Lisa M. Cordes
Vignettes on Population Pharmacokinetic Modeling Part 2 of 2 with Dr. Robert R. Bies
Vignettes on Population Pharmacokinetic Modeling Part 1 of 2 with Dr. Robert R. Bies
Compartmental Analysis of Drug Distribution with Dr. Arthur Atkinson
Drug Transporters in ADME and Drug Action with Dr. Joseph Ware
P-Glycoprotein and Drug Transport Part 1 of 2 with Dr. Michael Gottesman
P-Glycoprotein and Drug Transport Part 2 of 2 with Dr. Matthew Hall

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