The Journal of Clinical Pharmacology

Cover image for Vol. 57 Issue 6

Edited By: Joseph S. Bertino, Jr., Schenectady, NY

Online ISSN: 1552-4604

Associated Title(s): Clinical Pharmacology in Drug Development

Featured

  • Evidence for the hERG Liability of Antihistamines, Antipsychotics, and Anti-Infective Agents: A Systematic Literature Review From the ARITMO Project

    Evidence for the hERG Liability of Antihistamines, Antipsychotics, and Anti‐Infective Agents: A Systematic Literature Review From the ARITMO Project

    Flow chart of search results and eligibility assessment.

  • Impact of Target-Mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

    Impact of Target‐Mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

    Diagnostic plots of model-predicted and observed unbound evolocumab concentrations, unbound PCSK9 concentrations, and LDL-C.

  • Model-Based Dose Selection for Intravaginal Ring Formulations Releasing Anastrozole and Levonorgestrel Intended for the Treatment of Endometriosis Symptoms

    Model‐Based Dose Selection for Intravaginal Ring Formulations Releasing Anastrozole and Levonorgestrel Intended for the Treatment of Endometriosis Symptoms

    Representative individual concentration-time plots (observation vs model prediction based on the final population PK model) of sex hormone binding globulin (SHBG) and total levonorgestrel (LNG) for 4 subjects. On the left-hand side (Ia for SHBG and Ib for total LNG), no estradiol (E2) effect was included; on the right-hand side the E2 effect was included (IIa for SHBG and IIb for total LNG). The first intravaginal ring (IVR) was placed at 0 hours and was changed at 672 hours (after 28 days). There was no ring-free interval. Circles, observations; solid line, individual model prediction; dashed line, population model prediction; vertical dashed line, ring removal.

  • Population Pharmacokinetics and Exposure–Response Relationship of Carfilzomib in Patients With Multiple Myeloma

    Population Pharmacokinetics and Exposure–Response Relationship of Carfilzomib in Patients With Multiple Myeloma

    Prediction-corrected visual predictive check of the final population pharmacokinetic model. Gray circles represent observed carfilzomib concentrations. Red-line- and blue-line-shaded areas represent median and 95% prediction interval of the simulated prediction-corrected carfilzomib concentrations (based on 500 replicates of the analysis data set). Bins for prediction correction were selected to ensure a minimum number of observations (at least 200) per bin.

  • Evidence for the hERG Liability of Antihistamines, Antipsychotics, and Anti‐Infective Agents: A Systematic Literature Review From the ARITMO Project
  • Impact of Target‐Mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
  • Model‐Based Dose Selection for Intravaginal Ring Formulations Releasing Anastrozole and Levonorgestrel Intended for the Treatment of Endometriosis Symptoms
  • Population Pharmacokinetics and Exposure–Response Relationship of Carfilzomib in Patients With Multiple Myeloma

Recently Published Issues

See all

Download the JCP app

Keep up to date with the most important advancements in drug development, faster than ever, with complete issues available in the new iPad® /iPhone® app.

Featured issues and articles

Virtual Issue - Core Entrustables in Clinical Pharmacology: Pearls for Clinical Practice
Free Online access


Clinical Pharmacology teaching has been reduced greatly in many medical schools which is reflected in the lack of understanding of basic principles of drug use during medical residency training. ACCP believes that this lack of formal teaching has created a substantial deficiency in the training of physicians as they progress through medical residency programs. As a result, the ACCP, working with the Association of American Medical Colleges (AAMC) has developed a series entitled: “Core Entrustables in Clinical Pharmacology: Pearls for Clinical Practice.” These articles, written by a multidisciplinary group of ACCP members, provides the reader with an overview of topics considered important to understand to optimize the use of drugs in patients. While the AAMC’s activities are specific to medical training, these educational articles are appropriate for pharmacists, nurses, physician’s assistants and other health care professionals to develop a basic understanding of the principles of clinical pharmacology. We believe that the material contained in this virtual issue can be used for years to come, as the basic concepts presented in the articles herein change little over time.

July Editor's Choice article - Preliminary Evidence for the Off-Label Treatment of Bulimia Nervosa With Psychostimulants: Six Case Reports
Free Online access

Aaron Keshen and Thomas Helson

Bulima Nervosa (with accompanying binge/purge episodes) is a condition that affects people with and without attention deficit/hyperactivity disorder (ADHD). While persons with ADHD have a higher incididence of bulima nervosa (1.9%), those in the general population have an incidence of 0.4%. The use of psychostimulants in persons with bulima nervosa but without ADHD has been controversial. This month’s Editor’s Choice article present preliminary data on the use of psychostimulants in persons with bulima nervosa without ADHD. The authors found that the use of psychostimulants resulted in a positive effect on binge/purge days with one patient experiencing complete remission of symptoms. Further study of the use of psychostimulants in this condition in patients without ADHD is warranted.

June Editor’s Choice article - The Bial 10-2474 Phase 1 Study—A Drug Development Perspective and Recommendations for Future First-in-Human Trials
Free Online access
Philip Chaikin

This month’s editor’s choice article reviews using previously unavailable data, the incident with the drug Bial-10-2474 and the resultant death of a healthy volunteer in 2016. The study conducted by Biotrials was a multiple ascending dose study in healthy volunteers. The author of this manuscript, an individual who has been involved with drug development for decades, reviews and analyzes the issues involved with this study and offers expert recommendations. The paper is not meant to be a complete review of the topic, but meant to open a discussion about phase I study conduct.

May Editor’s Choice article - Model-Based Dose Selection for Intravaginal Ring Formulations Releasing Anastrozole and Levonorgestrel Intended for the Treatment of Endometriosis Symptoms
Free Online access
Isabel Reinecke, Marcus-Hillert Schultze-Mosgau, et al.

Endometriosis affects many young women, causing pain, dysmenorrhea, and other symptoms that affect the quality of life. Traditional therapy has attempted to reduce estrogen effects through suppression of systemic endogenous production. However, estrogens place an important role in the body including improving bone mineral density reducing fracture risk. Newer therapies have targeted the production of estrogens locally at the site of endometriosis to reduce systemic adverse effects. This month’s Editor’s Choice article examines the use of an intravaginal ring containing the aromatase inhibitor anastrozole (to reduce local estrogen production) and the progestin, levonogestrel (for treatment), combined with model-based dose selection to minimize follicle production and thus, reduce the risk of treatment induced ovarian cysts. It is estimated that the overall lifetime risk of endometriosis in women could be as high as 2.2%. Thus, more effective and less toxic treatments are needed.

Special Issue – Transporters
Free Online access


Knowledge about the role and importance of transporters has increased dramatically in the last decade. Transporters play an important role in determining pharmacokinetics and pharmacodynamics of drugs. We appreciate the pharmacogenomic and environmental effects determining transporter activity. This issue examines the role of transporters in drug development and in the clinical care of patients. A discussion of transporters in various organ systems and drug-drug interactions involving transporters highlight this issue. Our evolving knowledge of transporters and their functions will assist in the quest to personalize medicine for specific patients in the future. While our knowledge is still evolving, science has made great strides in explaining the importance of transporters in drug therapy.

Journal News

JCP Editors choice articles

JCP Top downloaded articles

JCP_ContinuingEducation

Did you know?
-The average time from submission to first decision is just 14 days
-Open access option is available for authors who wish to make their article free to all
See Author guidelines and Submit today!

Learn more about JCP's sister journal: Clinical Pharmacology in Drug Development
Clinical Pharmacology in Drug Development

Recent Articles

Subscribe to RSS headline updates from:
Powered by FeedBurner

Final version of the article available online approximately 30 days after acceptance via Early View

SEARCH

SEARCH BY CITATION