Principles of Clinical Pharmacology (course facilitator – T. Sandritter) is a general clinical pharmacology course (30 hr total) sponsored by the NIH Clinical Center. This weekly lecture series covers the fundamentals of clinical pharmacology as a translational scientific discipline which spans the continuum of drug discovery through therapeutic use. Faculty for this course include NIH staff and distinguished scientists from the pharmaceutical industry, FDA and academic institutions. The most recent lectures will be viewed online and the companion text will be purchased for each trainee. Fellows will take a 10-question self-assessment test prepared by the course facilitator) for each lecture and will convene with the facilitator, or a faculty member, to discuss each topic area.
Developmental Pharmacology (course director – N/A) The original 12-hour didactic course developed for fellows at has been replaced by the NIH T32 Pediatric Clinical Pharmacology webinar series. This weekly series address the fundamentals of clinical pharmacology, including drug metabolism and transport, assessment of drug effects, pharmacotherapy, and pediatric drug formulations from a pediatric perspective. The course is taught by faculty from leading academic institutions (including Children’s Mercy), the NIH, and the FDA.
Introduction to Pharmacokinetics/Pharmacodynamics (course director – J.S. Leeder), over a 3 month time frame, provides trainees with a comprehensive, functional understanding of the processes (physiologic and mathematical) used to quantitate drug disposition (e.g. drug liberation, absorption, distribution, metabolism, excretion) and response.
Applied Pharmacokinetics I and II (course director – S.M. Abdel-Rahman) represent two experiential, trainee-paced courses that introduce fellows to both classical and population-based approaches for analyzing PK/PD data. Applied PK I focuses on bedside or clinical PK applications and is entirely case-based. Applied PK II is also case-based, examining larger PK-PD datasets derived from investigator initiated and industry sponsored studies. Software applications introduced in this course include Kinetica, Phoenix, WinNonLin, NONMEM, and Simcyp.
Survey in Pharmacogenomics (course director – A. Gaedigk) provides trainees with a conceptual and factual basis regarding the role of pharmacogenomics as a determinant of drug disposition and action. The course consists of two modules; the first focuses on genomic determinants of PK and PD, the role of pharmacogenomics in pediatric drug development and relevant contemporary bioethical issues, the second provides a comprehensive overview of the tools and technologies that are currently used to support research in the field and contemporary issues in genomic research (e.g. epigenetics, epistasis, applied statistical genetics). This module also introduces trainees to the emerging field of translational bioinformatics where computational and biostatistical methods are integrated to explore genomic data which can define the expression of disease and its response to treatments. Concepts germane to the field such as GWAS and DNA sequence analysis, SNP and haplotype analysis, next-generation DNA sequencing, meta-analysis of “-omics” (genomics, proteomics, metabolomics) data, expression quantitative trait loci analysis and the generation of data-driven hypothesis are covered. The experiential portion of this course will consist of six guided laboratory experiences (3 hr each) intended to provide “hands-on” training in techniques germane to PG (e.g., PCR-RFLP, qPCR, sequencing, microarray). A separate “hands-on” application introduces trainees to commonly used bio-computing tools.
Pediatric Drug Development (course director – R.E. Kauffman; 9 hour didactic) is an interactive, bi-monthly, seminar intended to introduce trainees to the aspects of the drug development process which includes drug discovery, pre-clinical testing, human clinical trials and bioethical issues. The format for the course includes interactive didactic presentations, assigned readings and case presentations.
Pharmacoepidemiology (course director – D. Yin), This mini-series is intended to provide trainees with a conceptual, working understanding of pharmacoepidemiology-based research from the conceptual (developing pharmacoepidemiology-related hypotheses) to the operational (data cleaning, data queries, compliant data management, outcomes research data management).