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2.  Evidence of effectiveness: How much can we extrapolate from existing studies? 
The AAPS Journal  2005;7(2):E467-E474.
Drug development can be a science of extrapolation if the use of a drug exposure-response relationship is embraced and implemented through mechanistically oriented pharmacokinetic (PK)-pharmacodynamic (PD) modeling analysis and clinical trial simulation. The traditional requirement of at least 2 adequate and well-controlled phase III studies by the US Food and Drug Administration for drug approval can be waived in certain situations, substantially reducing the resources and time. In this article, the authors introduce a real drug development case where the chance for this exemption was maximized by actively using PK-PD modeling followed by clinical trial simulation, resulting in faster and more economical introduction of a new dosage regimen to patients.
doi:10.1208/aapsj070247
PMCID: PMC2750984  PMID: 16353924
extrapolation; drug development science; pharmacokinetic-pharmacodynamic modeling; exposure-response relationship; etanercept
3.  Physiologically based pharmacokinetics in Drug Development and Regulatory Science: A workshop report (Georgetown University, Washington, DC, May 29–30, 2002) 
AAPS PharmSci  2004;6(1):56-67.
A 2-day workshop on “Physiologically Based Pharmacokinetics (PBPK) in Drug Development and Regulatory Science” came to a successful conclusion on May 30, 2002, in Washington, DC. More than 120 international participants from the environmental and predominantly pharmaceutical industries, Food and Drug Administration (FDA), and universities attended this workshop, organized by the Center for Drug Development Science, Georgetown University, Washington, DC. The first of its kind specifically devoted to the subject, this intensive workshop, comprising 7 plenary presentations and 10 breakout sessions addressed 2 major objectives: (1) to “define demonstrated and potential contributions of PBPK in drug development and regulatory science,” and (2) to “assess current PBPK methodologies with the identification of their limitations and outstanding issues.” This report summarizes the presentations and recommendations that emerged from the workshop, while providing key references, software, and PBPK data sources in the appendices. The first day was initially devoted to presentations setting the stage and providing demonstrated applications to date. This was followed by breakout sessions that considered further opportunities and limitations, and which extended into Day 2 to deal with developments in methodologies and tools. Although the primary emphasis was on pharmacokinetics, consideration was also given to its integration specifically with mechanism-based pharmacodynamics.
doi:10.1208/ps060106
PMCID: PMC2750941  PMID: 18465258
4.  Clinical Pharmacokinetics: A Simplified Approach, Part 2 
Part 1 of this two-part series in clinical pharmacokinetics (J Natl Med Assoc 1985; 77:475-482) introduced the clinician to the basic principles required for rational therapeutic drug management at the bedside. Practical problems were included that demonstrated how these principles could be put to clinical use.
In Part 2 the clinical pharmacology of three commonly used drugs (theophylline, digoxin and gentamicin) are discussed, and practical problems are presented to illustrate the use of their pharmacokinetic profiles.
PMCID: PMC2571381  PMID: 3783759
5.  Clinical Pharmacokinetics: A Simplified Approach, Part 1 
Clinicians often find that the application of pharmacokinetic principles for the calculation of a drug regimen is bewildering and difficult. In this article it is shown that clinically useful calculations can be simply done at the bedside using a handheld calculator. The only requirement is an understanding of the terms that define the pharmacokinetic behavior of a drug. Appropriate manipulation of these terms will allow calculation of loading and maintenance doses, peak and average plasma concentrations, and other useful pharmacological data. The result will be improvement in drug therapy.
PMCID: PMC2571154  PMID: 4020891
6.  A Microcomputer Drug (Theophylline) Dosing Program Which Assists and Teaches Physicians 
A prototype, microcomputer-based, drug dosing program is described which assists physicians in making optimal dosing decisions. In addition, the physician can learn pharmacokinetic principles from the graphical output which depicts the consequences of dosing decisions, past and future.
PMCID: PMC2203831

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