Clinical pharmacology in drug development - an update.

Abstract

We are at the midpoint of the fourth year of publication of Clinical Pharmacology in Drug Development (CPDD). Including this issue, we have to date published a total of 164 original research articles and 18 editorials, as well as the scientific abstracts for annual meetings of the American College of Clinical Pharmacology. CPDD is fortunate to operate under the leadership of the American College of Clinical Pharmacology (ACCP), and the ACCP Publications Committee. The CPDD managing editors, Marjory M. Spraycar and Elizabeth Marshall, have provided flawless management of journal operations, and we benefit from the continuous assistance and advocacy of our publisher, Wiley Periodicals, Inc. CPDD looks to the partnership of the Journal of Clinical Pharmacology, ACCP's “senior” journal operating since 1961, as the standard for excellence in scientific publication. The Editorial Board of CPDD consists of distinguished basic and clinical scientists in the field of clinical pharmacology, who represent the academic, regulatory, and industrial aspects of the discipline. The Board provides strategic oversight and advice to the Editor, as well as assistance with operational matters as needed. We are very pleased that the Editorial Board will be further strengthened through the addition of 2 internationally known scientists who have agreed to join. Dr. Gerd Mikus is Deputy Medical Director of the Department of Clinical Pharmacology and Pharmacoepidemiology, and Associate Professor, at the University of Heidelberg, Heidelberg, Germany. He has made numerous research contributions in the areas of clinical pharmacokinetics, pharmacodynamics, and drug interactions. Dr. Amin Rostami-Hodjegan is Professor of Systems Pharmacology at the Center for Applied Pharmacokinetic Research, Manchester Pharmacy School, Manchester, United Kingdom. He is best known for his innovative contributions to the field of physiologically-based pharmacokinetic/pharmacodynamic modeling, and his founding of Simcyp, Ltd. Drs. Mikus and Rostami-Hodjegan bring unique talents and excellence to the Editorial Board, and also indicate CPDD's determination to develop a global reach in clinical pharmacology. Representative recent publications by our new board members are provided below. The core mission of CPDD as a peer-reviewed medical and scientific journal is to serve as a forum for publication of high-quality scientific articles reporting on clinical studies generally done as part of the drug development process. CPDD will publish articles reporting the outcome of Phase 1 single- and multiple-dose trials, dose-proportionality studies, pharmacokinetic-pharmacodynamic studies, drug–drug interaction trials, studies in special populations (hepatic, renal, the elderly, pediatric patients, etc.), thorough QT studies, population pharmacokinetics, mass balance studies, and exploratory clinical trials. Scientific merit rather than global clinical impact is the principal criterion for acceptance. CPDD understands that the outcome of descriptive and “negative” studies provides important information that guides regulatory and therapeutic decisions. The excellence of studies published in CPDD reflects the high scientific standards of authors and their sponsors, as well as the dedication of numerous outside peer-reviewers who donate their time and expertise to improving the submitted articles. The content of CPDD already is indexed by international indexing services such as Google Scholar, Scopus, Embase, and Web of Science: Science Citation Index Expanded (SCIE). We are working toward extending that indexing coverage. CPDD encourages and welcomes submission of articles of this type — questions or inquiries should be directed to the Editor-in-Chief. We look forward to working with you in serving the clinical and scientific community. David J. Greenblatt, MD Editor-in-Chief Tufts University School of Medicine Boston, MA, USA Klimas R, Mikus G. Morphine-6-glucuronide is responsible for the analgesic effect after morphine administration: a quantitative review of morphine, morphine-6-glucuronide, and morphine-3-glucuronide. Br J Anaesth. 2014;113:935–944. Hohmann N, Kocheise F, Carls A, Burhenne J, Haefeli WE, Mikus G. Midazolam microdose to determine systemic and pre-systemic metabolic CYP3A activity in humans. Br J Clin Pharmacol. 2015;79:278–285. Dolton MJ, Mikus G, Weiss J, Ray JE, McLachlan AJ. Understanding variability with voriconazole using a population pharmacokinetic approach: implications for optimal dosing. J Antimicrob Chemother. 2014;69:1633–1641. Ziesenitz VC, Konig SK, Mahlke NS, Skopp G, Haefeli WE, Mikus G. Pharmacokinetic interaction of intravenous fentanyl with ketoconazole. J Clin Pharmacol. 2015;55:708–717. Olivares-Morales A, Kamiyama Y, Darwich AS, Aarons L, Rostami-Hodjegan A. Analysis of the impact of controlled release formulations on oral drug absorption, gut wall metabolism and relative bioavailability of CYP3A substrates using a physiologically-based pharmacokinetic model. Eur J Pharm Sci. 2015;67:32–44. Machavaram KK, Almond LM, Rostami-Hodjegan A, et al. A physiologically based pharmacokinetic modeling approach to predict disease-drug interactions: suppression of CYP3A by IL-6. Clin Pharmacol Ther. 2013;94:260–268. Achour B, Barber J, Rostami-Hodjegan A. Expression of hepatic drug-metabolizing cytochrome P450 enzymes and their intercorrelations: a meta-analysis. Drug Metab Dispos. 2014;42:1349–1356. Tsamandouras N, Rostami-Hodjegan A, Aarons L. Combining the 'bottom up' and 'top down' approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data. Br J Clin Pharmacol. 2015;79:48–55.