American College of Clinical Pharmacology

American College of Clinical Pharmacology American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing exceptional interdisciplinary,

Founded in 1969 by a group of eminent physicians, the College today consists of a full spectrum of healthcare professionals who remain dedicated to advancing clinical pharmacology with the goal of providing exceptional patient care. As an organization whose primary role is education, the College does not concentrate on any one aspect of the discipline. Rather, the College seeks to address the edu

Founded in 1969 by a group of eminent physicians, the College today consists of a full spectrum of healthcare professionals who remain dedicated to advancing clinical pharmacology with the goal of providing exceptional patient care. As an organization whose primary role is education, the College does not concentrate on any one aspect of the discipline. Rather, the College seeks to address the edu

Operating as usual

ACCP is pleased to share a WNYT NewsChannel 13 interview of Joseph S. Bertino Jr, PharmD, FCP, FCCP, Editor-in-Chief of ...
11/19/2021
Health Beat: COVID-19 Drugs Awaiting Approval

ACCP is pleased to share a WNYT NewsChannel 13 interview of Joseph S. Bertino Jr, PharmD, FCP, FCCP, Editor-in-Chief of The Journal of Clinical Pharmacology. In the Health Beat segment, Dr. Bertino discusses #COVID19 antiviral drugs from @Pfizer & @MerckInvents that are waiting for #FDA approval.

Please take a few minutes to view the interview here: https://bit.ly/327TC3q

Pfizer and Merck are both touting their antiviral drugs still waiting for FDA approval as game-changers for saving lives affected by COVID-19. How do they work, and what about monoclonal antibody treatment by Lilly and Regeneron? Where do they fit in the treatment game? How does all this play out wi...

Looking for that dream job? We may have just what you are looking for on the #ACCPJOBCTR! http://bit.ly/2J0TTKj#pharmaco...
11/19/2021

Looking for that dream job? We may have just what you are looking for on the #ACCPJOBCTR! http://bit.ly/2J0TTKj
#pharmacology #jobsearch

Looking for that dream job? We may have just what you are looking for on the #ACCPJOBCTR! http://bit.ly/2J0TTKj
#pharmacology #jobsearch

LAST CHANCE to Register for the #ACCPVJC Webinar: Effect of Hepatic Impairment on #Cobimetinib #Pharmacokinetics: The Co...
11/16/2021

LAST CHANCE to Register for the #ACCPVJC Webinar: Effect of Hepatic Impairment on #Cobimetinib #Pharmacokinetics: The Complex Interplay Between Physiological Changes & Drug Characteristics, tomorrow, Nov 17th @ 2:00 PM ET.

Register today: https://bit.ly/3pm29JS

We look forward to your participation!

LAST CHANCE to Register for the #ACCPVJC Webinar: Effect of Hepatic Impairment on #Cobimetinib #Pharmacokinetics: The Complex Interplay Between Physiological Changes & Drug Characteristics, tomorrow, Nov 17th @ 2:00 PM ET.

Register today: https://bit.ly/3pm29JS

We look forward to your participation!

Currently in Early View, ACCP's The Journal of Clinical Pharmacology article "Preventing a New Tuskegee: Food and Drug A...
11/15/2021

Currently in Early View, ACCP's The Journal of Clinical Pharmacology article "Preventing a New Tuskegee: Food and Drug Administration Oversight of Overseas Research Must Match That in the United States" addresses the concern regarding loopholes in the #FDA's oversight of research overseas.

As a result, there is no way of knowing the full extent of ethical breaches that have occurred in overseas clinical trials. There are solutions. This article is free to read. Please share with your colleagues that may find this topic of interest. https://bit.ly/3cgDJcK
#drugsafety #clinicaltrials

Currently in Early View, ACCP's The Journal of Clinical Pharmacology article "Preventing a New Tuskegee: Food and Drug Administration Oversight of Overseas Research Must Match That in the United States" addresses the concern regarding loopholes in the #FDA's oversight of research overseas.

As a result, there is no way of knowing the full extent of ethical breaches that have occurred in overseas clinical trials. There are solutions. This article is free to read. Please share with your colleagues that may find this topic of interest. https://bit.ly/3cgDJcK
#drugsafety #clinicaltrials

11/15/2021
Drug Permeability: BCS-based Biowaivers

The #FDA & the Univ of Maryland Center of Excellence in Regulatory Science & Innovation (M-CERSI) will host a virtual public workshop entitled “#DrugPermeability: Best Practices for #Biopharmaceutics Classification System-Based Biowaivers” on December 6th. This workshop will bring together stakeholders from FDA, academia, and industry in a virtual setting to discuss generating and evaluating permeability data to further facilitate the implementation of the Biopharmaceutics Classification System (BCS) and the efficient development of high-quality drug products globally. https://bit.ly/3kGWlqW

Thank you for your interest in the "Drug Permeability: Best Practices for BCS-based Biowaivers" workshop, sponsored by the U.S. Food and Drug Administration (FDA) and University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). Participants will convene virtually on Mo...

Need CE Credit by the End of the Year? Look No Further. ACCP is Your CE Resource!ACCP has a variety of Live, On Demand a...
11/10/2021

Need CE Credit by the End of the Year? Look No Further. ACCP is Your CE Resource!

ACCP has a variety of Live, On Demand and text-based online CE resources available for completion so you can fulfill your CE requirements. Visit ACCP Continuing Education to learn more. https://bit.ly/2In0yQC

ACCP Journal CE: https://bit.ly/3kdVY47
ACCP Virtual Journal Club: https://bit.ly/2ImMjLR
Student, Trainee & Early-stage Professional Webinars: https://bit.ly/300dsg1
Clinical Practice Webinars: https://bit.ly/3D1VM26
Other ACCP Webinars: https://bit.ly/3lfs7tk

Most courses are FREE so don't delay in getting your #CME & #CPE credits today!

Need CE Credit by the End of the Year? Look No Further. ACCP is Your CE Resource!

ACCP has a variety of Live, On Demand and text-based online CE resources available for completion so you can fulfill your CE requirements. Visit ACCP Continuing Education to learn more. https://bit.ly/2In0yQC

ACCP Journal CE: https://bit.ly/3kdVY47
ACCP Virtual Journal Club: https://bit.ly/2ImMjLR
Student, Trainee & Early-stage Professional Webinars: https://bit.ly/300dsg1
Clinical Practice Webinars: https://bit.ly/3D1VM26
Other ACCP Webinars: https://bit.ly/3lfs7tk

Most courses are FREE so don't delay in getting your #CME & #CPE credits today!

LAST CHANCE to Register for the ACCP Fundamentals Tutorials - Clinical Applications Webinar Part 1: Intro to #Microbiome...
11/09/2021

LAST CHANCE to Register for the ACCP Fundamentals Tutorials - Clinical Applications Webinar Part 1: Intro to #Microbiome & the Impact on #DrugDisposition & Variability, tomorrow, Nov 10th @ 2:00 PM ET. Register today-https://bit.ly/3DWt82x

We look forward to your participation!

LAST CHANCE to Register for the ACCP Fundamentals Tutorials - Clinical Applications Webinar Part 1: Intro to #Microbiome & the Impact on #DrugDisposition & Variability, tomorrow, Nov 10th @ 2:00 PM ET. Register today-https://bit.ly/3DWt82x

We look forward to your participation!

Clinical Pharmacology in Drug Development, November 2021 Volume 10, Issue 11 is now available! https://bit.ly/39XjxMS*Co...
11/09/2021

Clinical Pharmacology in Drug Development, November 2021 Volume 10, Issue 11 is now available! https://bit.ly/39XjxMS

*Commentary*
Should Estimated Glomerular Filtration Rate Be Adjusted for Race?
Brian J. Cohen
Pages: 1254-1262 | First Published: 04 November 2021

*Articles*
Single- and Multiple-Dose Pharmacokinetics and Pharmacodynamics of PN-943, a Gastrointestinal-Restricted Oral Peptide Antagonist of α4β7, in Healthy Volunteers
Nish*t B. Modi, Xiaoli Cheng, Larry Mattheakis, Ching-Chang Hwang, Roya Nawabi, David Liu, Suneel Gupta
Pages: 1263-1278 | First Published: 04 May 2021

A Phase 1 Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Trial to Investigate the Effect of Cannabidiol on the CYP1A2 Probe Caffeine in Healthy Subjects
Ching Thai, Bola Tayo, David Critchley
Pages: 1279-1289 | First Published: 05 May 2021

Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan
Ki Young Huh, Sang Won Lee, Si Beum Lee, Kyung Tae Kim, In-Jin Jang, SeungHwan Lee
Pages: 1290-1296 | First Published: 01 March 2021

Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations
Daryl J. Fediuk, Vaishali Sahasrabudhe, Vikas Kumar Dawra, Susan Zhou, Kevin Sweeney
Pages: 1297-1306 | First Published: 02 July 2021

Mechanistic Considerations About an Unexpected Ramipril Drug-Drug Interaction in the Development of a Triple Fixed-Dose Combination Product Containing Ramipril, Amlodipine, and Atorvastatin
Robert Hermann, Kristina Gundlach, Dan Seiler
Pages: 1307-1315 | First Published: 27 March 2021

Pharmacokinetics of Opicapone and Its Metabolites in Healthy White and Chinese Subjects
Wei Xue, Yan Tan, Yue Liu, Changjiang Xu, Duanduan Cong, Liping Zhong, Jie Song, Aimin Hui, Wenyuan Qi, Juan Wang, Xiaohui Liu, Kexin Li
Pages: 1316-1324 | First Published: 17 April 2021

The Pharmacokinetics of Triheptanoin and Its Metabolites in Healthy Subjects and Patients With Long-Chain Fatty Acid Oxidation Disorders
Sun Ku Lee, Manju Gupta, Jack Shi, Kathleen McKeever
Pages: 1325-1334 | First Published: 31 March 2021

Effect of Upadacitinib on the Pharmacokinetics of Rosuvastatin or Atorvastatin in Healthy Subjects
Mohamed-Eslam F. Mohamed, Sheryl Coppola, Tian Feng, Heidi S. Camp, Elaine Kim, Ahmed A. Othman
Pages: 1335-1344 | First Published: 09 June 2021

Base and Covariate Population Pharmacokinetic Analyses of Dupilumab in Adolescents and Children ≥6 to

Clinical Pharmacology in Drug Development, November 2021 Volume 10, Issue 11 is now available! https://bit.ly/39XjxMS

*Commentary*
Should Estimated Glomerular Filtration Rate Be Adjusted for Race?
Brian J. Cohen
Pages: 1254-1262 | First Published: 04 November 2021

*Articles*
Single- and Multiple-Dose Pharmacokinetics and Pharmacodynamics of PN-943, a Gastrointestinal-Restricted Oral Peptide Antagonist of α4β7, in Healthy Volunteers
Nish*t B. Modi, Xiaoli Cheng, Larry Mattheakis, Ching-Chang Hwang, Roya Nawabi, David Liu, Suneel Gupta
Pages: 1263-1278 | First Published: 04 May 2021

A Phase 1 Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Trial to Investigate the Effect of Cannabidiol on the CYP1A2 Probe Caffeine in Healthy Subjects
Ching Thai, Bola Tayo, David Critchley
Pages: 1279-1289 | First Published: 05 May 2021

Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan
Ki Young Huh, Sang Won Lee, Si Beum Lee, Kyung Tae Kim, In-Jin Jang, SeungHwan Lee
Pages: 1290-1296 | First Published: 01 March 2021

Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations
Daryl J. Fediuk, Vaishali Sahasrabudhe, Vikas Kumar Dawra, Susan Zhou, Kevin Sweeney
Pages: 1297-1306 | First Published: 02 July 2021

Mechanistic Considerations About an Unexpected Ramipril Drug-Drug Interaction in the Development of a Triple Fixed-Dose Combination Product Containing Ramipril, Amlodipine, and Atorvastatin
Robert Hermann, Kristina Gundlach, Dan Seiler
Pages: 1307-1315 | First Published: 27 March 2021

Pharmacokinetics of Opicapone and Its Metabolites in Healthy White and Chinese Subjects
Wei Xue, Yan Tan, Yue Liu, Changjiang Xu, Duanduan Cong, Liping Zhong, Jie Song, Aimin Hui, Wenyuan Qi, Juan Wang, Xiaohui Liu, Kexin Li
Pages: 1316-1324 | First Published: 17 April 2021

The Pharmacokinetics of Triheptanoin and Its Metabolites in Healthy Subjects and Patients With Long-Chain Fatty Acid Oxidation Disorders
Sun Ku Lee, Manju Gupta, Jack Shi, Kathleen McKeever
Pages: 1325-1334 | First Published: 31 March 2021

Effect of Upadacitinib on the Pharmacokinetics of Rosuvastatin or Atorvastatin in Healthy Subjects
Mohamed-Eslam F. Mohamed, Sheryl Coppola, Tian Feng, Heidi S. Camp, Elaine Kim, Ahmed A. Othman
Pages: 1335-1344 | First Published: 09 June 2021

Base and Covariate Population Pharmacokinetic Analyses of Dupilumab in Adolescents and Children ≥6 to

The Leadership of the American College of Clinical Pharmacology® is pleased to welcome the participants in the 2022 ACCP...
11/05/2021

The Leadership of the American College of Clinical Pharmacology® is pleased to welcome the participants in the 2022 ACCP Leadership Development Program!

Please welcome...

Kristina Brooks, PharmD
Ayyappa Chaturvedula, PhD, FCP
Brian Cicali, BS, MS
Oliver Grundmann, PhD, FCP
Alexander Prokopienko, PharmD, PhD

The society looks forward to your growth and continued contributions within ACCP!

Learn more about the ACCP Leadership Development Program...https://bit.ly/3srWAsc

The Leadership of the American College of Clinical Pharmacology® is pleased to welcome the participants in the 2022 ACCP Leadership Development Program!

Please welcome...

Kristina Brooks, PharmD
Ayyappa Chaturvedula, PhD, FCP
Brian Cicali, BS, MS
Oliver Grundmann, PhD, FCP
Alexander Prokopienko, PharmD, PhD

The society looks forward to your growth and continued contributions within ACCP!

Learn more about the ACCP Leadership Development Program...https://bit.ly/3srWAsc

❗ The ACCP Fundamentals Tutorials - Clinical Applications Webinar Part 1: Introduction to #Microbiome & the Impact on #D...
11/04/2021

❗ The ACCP Fundamentals Tutorials - Clinical Applications Webinar Part 1: Introduction to #Microbiome & the Impact on #DrugDisposition & Variability is NEXT WEEK!

November 10th | 2:00 - 3:30 PM ET | Learn more: https://bit.ly/3DWt82x

This is a not to be missed event for Students & Trainees or those looking to supplement basic clinical pharmacology information previously not available to you.

This is Part 1 of a 3-part webinar series. Attendees that complete all three components and take the post-event test will be awarded a certificate of completion and digital badge that can be shared on your social media accounts highlighting the skills you have obtained.

We look forward to your participation and please share with your colleagues that may benefit from this webinar series!

❗ The ACCP Fundamentals Tutorials - Clinical Applications Webinar Part 1: Introduction to #Microbiome & the Impact on #DrugDisposition & Variability is NEXT WEEK!

November 10th | 2:00 - 3:30 PM ET | Learn more: https://bit.ly/3DWt82x

This is a not to be missed event for Students & Trainees or those looking to supplement basic clinical pharmacology information previously not available to you.

This is Part 1 of a 3-part webinar series. Attendees that complete all three components and take the post-event test will be awarded a certificate of completion and digital badge that can be shared on your social media accounts highlighting the skills you have obtained.

We look forward to your participation and please share with your colleagues that may benefit from this webinar series!

The Journal of Clinical Pharmacology - November 2021, Vol 61, Issue 11 is now available!http://bit.ly/2Ijxci7*Continuing...
11/02/2021

The Journal of Clinical Pharmacology - November 2021, Vol 61, Issue 11 is now available!
http://bit.ly/2Ijxci7

*Continuing Education: Review*
Risk of Thrombocytopenia With Platelet-Derived Growth Factor Receptor Kinase Inhibitors in Cancer Patients: A Systematic Review and Meta-Analysis of Phase 2/3 Randomized, Controlled Trials
Yuan Liu MS, Wenxia Sun MS, Jing Li MS
Pages: 1397-1405 | First Published: 09 July 2021

*Editor's Choice: Therapeutics*
Influence of Prednisone on Inflammatory Biomarkers in Community-Acquired Pneumonia: Secondary Analysis of a Randomized Trial
Natalie Raess BMed, Philipp Schuetz MD, MPH, Nicole Cesana-Nigro MD, Bettina Winzeler MD, Sandrine A. Urwyler MD, Sabine Schaedelin MSc, Nicolas Rodondi MD, MAS, Manuel R. Blum MD, MSc, Matthias Briel MD, MSc, Beat Mueller MD, Mirjam Christ-Crain MD, PhD, Claudine A. Blum MD
Pages: 1406-1414 | First Published: 25 May 2021

*Therapeutics*
Cisatracurium Continuous Infusion Versus No Neuromuscular Blockade for Acute Respiratory Distress Syndrome on Venovenous Extracorporeal Membrane Oxygenation
Christian Kressin PharmD, Melissa Thompson Bastin PharmD, PhD, Ayesha Ather PharmD, Anil Gopinath MD, Habib Srour MD, Aric Schadler PhD, Komal Pandya PharmD
Pages: 1415-1420 | First Published: 28 June 2021

Ketamine for Refractory Chronic Migraine: An Observational Pilot Study and Metabolite Analysis
Eric S. Schwenk MD, Marc C. Torjman PhD, Ruin Moaddel PhD, Jacqueline Lovett MS, Daniel Katz DO, William Denk MD, Clinton Lauritsen DO, Stephen D. Silberstein MD, Irving W. Wainer PhD
Pages: 1421-1429 | First Published: 14 June 2021

*Pharmacometrics*
Population Pharmacokinetics of Olanzapine and Samidorphan When Administered in Combination in Healthy Subjects and Patients With Schizophrenia
Lei Sun PhD, Richard Mills PhD, Brian M. Sadler PhD, Bhaskar Rege PhD
Pages: 1430-1441 | First Published: 21 May 2021

A Target-Mediated Drug Disposition Model to Explain Nonlinear Pharmacokinetics of the 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor SPI-62 in Healthy Adults
Nan Wu MS, David A. Katz PhD, Guohua An MD, PhD
Pages: 1442-1453 | First Published: 10 June 2021

*Special Populations*
Pharmacokinetics of Asciminib in Individuals With Hepatic or Renal Impairment
Matthias Hoch PhD, Masahiko Sato PhD, Julia Zack PharmD, Michelle Quinlan PhD, Tirtha Sengupta MSc, Alex Allepuz MD, Paola Aimone MD, Florence Hourcade-Potelleret PhD
Pages: 1454-1465 | First Published: 11 June 2021

*Drug Development*
Biperiden Challenge Model in Healthy Elderly as Proof-of-Pharmacology Tool: A Randomized, Placebo-Controlled Trial
Charlotte Bakker MD, Michiel J. van Esdonk PhD, Rik (F). E. Stuurman PhD, Laura G.J.M. Borghans PhD, Marieke L. de Kam MSc, Joop M.A. van Gerven MD, PhD, Geert Jan Groeneveld MD, PhD
Pages: 1466-1478 | First Published: 21 May 2021

*Pediatric Pharmacology*
Methods for Detecting Pediatric Adverse Drug Reactions From the Electronic Medical Record
Lydia M. Joyner MS, Leah A. Alicea, Jennifer L. Goldman MD, MS, Sarah L. Suppes PharmD, Emma M. Tillman PharmD, PhD
Pages: 1479-1484 | First Published: 25 May 2021

A Clinical Decision Support Tool to Find the Best Initial Intravenous Cyclosporine Regimen in Pediatric Hematopoietic Stem Cell Transplantation
Vincent Leclerc PharmD, Michel Ducher PharmD, Antony Ceraulo MD, Yves Bertrand MD, Nathalie Bleyzac PharmD
Pages: 1485-1492 | First Published: 08 June 2021

Physiologically Based Pharmacokinetic Modeling for Selumetinib to Evaluate Drug-Drug Interactions and Pediatric Dose Regimens
Sarit Cohen-Rabbie PhD, Li Zhou PhD, Karthick Vishwanathan PhD, Martin Wild PhD, Sherrie Xu PhD, Tomoko Freshwater PhD, Lokesh Jain PhD, Stein Schalkwijk PhD, PharmD, Helen Tomkinson MS, Diansong Zhou PhD
Pages: 1493-1504 | First Published: 01 July 2021

*Physiologically Based Pharmacokinetic Modeling*
Prediction of Fluoxetine and Norfluoxetine Pharmacokinetic Profiles Using Physiologically Based Pharmacokinetic Modeling
Hyeon-Cheol Jeong MS, Yoon-Jee Chae PhD, Sooyeun Lee PhD, Wonku Kang PhD, Hwi-yeol Yun PhD, Kwang-Hee Shin PhD
Pages: 1505-1513 | First Published: 12 June 2021

The Journal of Clinical Pharmacology - November 2021, Vol 61, Issue 11 is now available!
http://bit.ly/2Ijxci7

*Continuing Education: Review*
Risk of Thrombocytopenia With Platelet-Derived Growth Factor Receptor Kinase Inhibitors in Cancer Patients: A Systematic Review and Meta-Analysis of Phase 2/3 Randomized, Controlled Trials
Yuan Liu MS, Wenxia Sun MS, Jing Li MS
Pages: 1397-1405 | First Published: 09 July 2021

*Editor's Choice: Therapeutics*
Influence of Prednisone on Inflammatory Biomarkers in Community-Acquired Pneumonia: Secondary Analysis of a Randomized Trial
Natalie Raess BMed, Philipp Schuetz MD, MPH, Nicole Cesana-Nigro MD, Bettina Winzeler MD, Sandrine A. Urwyler MD, Sabine Schaedelin MSc, Nicolas Rodondi MD, MAS, Manuel R. Blum MD, MSc, Matthias Briel MD, MSc, Beat Mueller MD, Mirjam Christ-Crain MD, PhD, Claudine A. Blum MD
Pages: 1406-1414 | First Published: 25 May 2021

*Therapeutics*
Cisatracurium Continuous Infusion Versus No Neuromuscular Blockade for Acute Respiratory Distress Syndrome on Venovenous Extracorporeal Membrane Oxygenation
Christian Kressin PharmD, Melissa Thompson Bastin PharmD, PhD, Ayesha Ather PharmD, Anil Gopinath MD, Habib Srour MD, Aric Schadler PhD, Komal Pandya PharmD
Pages: 1415-1420 | First Published: 28 June 2021

Ketamine for Refractory Chronic Migraine: An Observational Pilot Study and Metabolite Analysis
Eric S. Schwenk MD, Marc C. Torjman PhD, Ruin Moaddel PhD, Jacqueline Lovett MS, Daniel Katz DO, William Denk MD, Clinton Lauritsen DO, Stephen D. Silberstein MD, Irving W. Wainer PhD
Pages: 1421-1429 | First Published: 14 June 2021

*Pharmacometrics*
Population Pharmacokinetics of Olanzapine and Samidorphan When Administered in Combination in Healthy Subjects and Patients With Schizophrenia
Lei Sun PhD, Richard Mills PhD, Brian M. Sadler PhD, Bhaskar Rege PhD
Pages: 1430-1441 | First Published: 21 May 2021

A Target-Mediated Drug Disposition Model to Explain Nonlinear Pharmacokinetics of the 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor SPI-62 in Healthy Adults
Nan Wu MS, David A. Katz PhD, Guohua An MD, PhD
Pages: 1442-1453 | First Published: 10 June 2021

*Special Populations*
Pharmacokinetics of Asciminib in Individuals With Hepatic or Renal Impairment
Matthias Hoch PhD, Masahiko Sato PhD, Julia Zack PharmD, Michelle Quinlan PhD, Tirtha Sengupta MSc, Alex Allepuz MD, Paola Aimone MD, Florence Hourcade-Potelleret PhD
Pages: 1454-1465 | First Published: 11 June 2021

*Drug Development*
Biperiden Challenge Model in Healthy Elderly as Proof-of-Pharmacology Tool: A Randomized, Placebo-Controlled Trial
Charlotte Bakker MD, Michiel J. van Esdonk PhD, Rik (F). E. Stuurman PhD, Laura G.J.M. Borghans PhD, Marieke L. de Kam MSc, Joop M.A. van Gerven MD, PhD, Geert Jan Groeneveld MD, PhD
Pages: 1466-1478 | First Published: 21 May 2021

*Pediatric Pharmacology*
Methods for Detecting Pediatric Adverse Drug Reactions From the Electronic Medical Record
Lydia M. Joyner MS, Leah A. Alicea, Jennifer L. Goldman MD, MS, Sarah L. Suppes PharmD, Emma M. Tillman PharmD, PhD
Pages: 1479-1484 | First Published: 25 May 2021

A Clinical Decision Support Tool to Find the Best Initial Intravenous Cyclosporine Regimen in Pediatric Hematopoietic Stem Cell Transplantation
Vincent Leclerc PharmD, Michel Ducher PharmD, Antony Ceraulo MD, Yves Bertrand MD, Nathalie Bleyzac PharmD
Pages: 1485-1492 | First Published: 08 June 2021

Physiologically Based Pharmacokinetic Modeling for Selumetinib to Evaluate Drug-Drug Interactions and Pediatric Dose Regimens
Sarit Cohen-Rabbie PhD, Li Zhou PhD, Karthick Vishwanathan PhD, Martin Wild PhD, Sherrie Xu PhD, Tomoko Freshwater PhD, Lokesh Jain PhD, Stein Schalkwijk PhD, PharmD, Helen Tomkinson MS, Diansong Zhou PhD
Pages: 1493-1504 | First Published: 01 July 2021

*Physiologically Based Pharmacokinetic Modeling*
Prediction of Fluoxetine and Norfluoxetine Pharmacokinetic Profiles Using Physiologically Based Pharmacokinetic Modeling
Hyeon-Cheol Jeong MS, Yoon-Jee Chae PhD, Sooyeun Lee PhD, Wonku Kang PhD, Hwi-yeol Yun PhD, Kwang-Hee Shin PhD
Pages: 1505-1513 | First Published: 12 June 2021

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General information

ACCP is a member-driven/member-focused organization that provides accredited continuing education to healthcare professionals. ACCP also publishes The Journal of Clinical Pharmacology and will soon publish the eJournal Clinical Pharmacology in Drug Development.

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Comments

ACCP is pleased to share a WNYT NewsChannel 13 interview of Joseph S. Bertino Jr, PharmD, FCP, FCCP, Editor-in-Chief of The Journal of Clinical Pharmacology. In the Health Beat segment, Dr. Bertino discusses #COVID19 antiviral drugs from @Pfizer & @MerckInvents that are waiting for #FDA approval. Please take a few minutes to view the interview here: https://bit.ly/327TC3q
Looking for that dream job? We may have just what you are looking for on the #ACCPJOBCTR! http://bit.ly/2J0TTKj #pharmacology #jobsearch
LAST CHANCE to Register for the #ACCPVJC Webinar: Effect of Hepatic Impairment on #Cobimetinib #Pharmacokinetics: The Complex Interplay Between Physiological Changes & Drug Characteristics, tomorrow, Nov 17th @ 2:00 PM ET. Register today: https://bit.ly/3pm29JS We look forward to your participation!
Currently in Early View, ACCP's The Journal of Clinical Pharmacology article "Preventing a New Tuskegee: Food and Drug Administration Oversight of Overseas Research Must Match That in the United States" addresses the concern regarding loopholes in the #FDA's oversight of research overseas. As a result, there is no way of knowing the full extent of ethical breaches that have occurred in overseas clinical trials. There are solutions. This article is free to read. Please share with your colleagues that may find this topic of interest. https://bit.ly/3cgDJcK #drugsafety #clinicaltrials
The #FDA & the Univ of Maryland Center of Excellence in Regulatory Science & Innovation (M-CERSI) will host a virtual public workshop entitled “#DrugPermeability: Best Practices for #Biopharmaceutics Classification System-Based Biowaivers” on December 6th. This workshop will bring together stakeholders from FDA, academia, and industry in a virtual setting to discuss generating and evaluating permeability data to further facilitate the implementation of the Biopharmaceutics Classification System (BCS) and the efficient development of high-quality drug products globally. https://bit.ly/3kGWlqW
Need CE Credit by the End of the Year? Look No Further. ACCP is Your CE Resource! ACCP has a variety of Live, On Demand and text-based online CE resources available for completion so you can fulfill your CE requirements. Visit ACCP Continuing Education to learn more. https://bit.ly/2In0yQC ACCP Journal CE: https://bit.ly/3kdVY47 ACCP Virtual Journal Club: https://bit.ly/2ImMjLR Student, Trainee & Early-stage Professional Webinars: https://bit.ly/300dsg1 Clinical Practice Webinars: https://bit.ly/3D1VM26 Other ACCP Webinars: https://bit.ly/3lfs7tk Most courses are FREE so don't delay in getting your #CME & #CPE credits today!
LAST CHANCE to Register for the ACCP Fundamentals Tutorials - Clinical Applications Webinar Part 1: Intro to #Microbiome & the Impact on #DrugDisposition & Variability, tomorrow, Nov 10th @ 2:00 PM ET. Register today-https://bit.ly/3DWt82x We look forward to your participation!
Clinical Pharmacology in Drug Development, November 2021 Volume 10, Issue 11 is now available! https://bit.ly/39XjxMS *Commentary* Should Estimated Glomerular Filtration Rate Be Adjusted for Race? Brian J. Cohen Pages: 1254-1262 | First Published: 04 November 2021 *Articles* Single- and Multiple-Dose Pharmacokinetics and Pharmacodynamics of PN-943, a Gastrointestinal-Restricted Oral Peptide Antagonist of α4β7, in Healthy Volunteers Nish*t B. Modi, Xiaoli Cheng, Larry Mattheakis, Ching-Chang Hwang, Roya Nawabi, David Liu, Suneel Gupta Pages: 1263-1278 | First Published: 04 May 2021 A Phase 1 Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Trial to Investigate the Effect of Cannabidiol on the CYP1A2 Probe Caffeine in Healthy Subjects Ching Thai, Bola Tayo, David Critchley Pages: 1279-1289 | First Published: 05 May 2021 Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan Ki Young Huh, Sang Won Lee, Si Beum Lee, Kyung Tae Kim, In-Jin Jang, SeungHwan Lee Pages: 1290-1296 | First Published: 01 March 2021 Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations Daryl J. Fediuk, Vaishali Sahasrabudhe, Vikas Kumar Dawra, Susan Zhou, Kevin Sweeney Pages: 1297-1306 | First Published: 02 July 2021 Mechanistic Considerations About an Unexpected Ramipril Drug-Drug Interaction in the Development of a Triple Fixed-Dose Combination Product Containing Ramipril, Amlodipine, and Atorvastatin Robert Hermann, Kristina Gundlach, Dan Seiler Pages: 1307-1315 | First Published: 27 March 2021 Pharmacokinetics of Opicapone and Its Metabolites in Healthy White and Chinese Subjects Wei Xue, Yan Tan, Yue Liu, Changjiang Xu, Duanduan Cong, Liping Zhong, Jie Song, Aimin Hui, Wenyuan Qi, Juan Wang, Xiaohui Liu, Kexin Li Pages: 1316-1324 | First Published: 17 April 2021 The Pharmacokinetics of Triheptanoin and Its Metabolites in Healthy Subjects and Patients With Long-Chain Fatty Acid Oxidation Disorders Sun Ku Lee, Manju Gupta, Jack Shi, Kathleen McKeever Pages: 1325-1334 | First Published: 31 March 2021 Effect of Upadacitinib on the Pharmacokinetics of Rosuvastatin or Atorvastatin in Healthy Subjects Mohamed-Eslam F. Mohamed, Sheryl Coppola, Tian Feng, Heidi S. Camp, Elaine Kim, Ahmed A. Othman Pages: 1335-1344 | First Published: 09 June 2021 Base and Covariate Population Pharmacokinetic Analyses of Dupilumab in Adolescents and Children ≥6 to
The Leadership of the American College of Clinical Pharmacology® is pleased to welcome the participants in the 2022 ACCP Leadership Development Program! Please welcome... Kristina Brooks, PharmD Ayyappa Chaturvedula, PhD, FCP Brian Cicali, BS, MS Oliver Grundmann, PhD, FCP Alexander Prokopienko, PharmD, PhD The society looks forward to your growth and continued contributions within ACCP! Learn more about the ACCP Leadership Development Program...https://bit.ly/3srWAsc
❗ The ACCP Fundamentals Tutorials - Clinical Applications Webinar Part 1: Introduction to #Microbiome & the Impact on #DrugDisposition & Variability is NEXT WEEK! November 10th | 2:00 - 3:30 PM ET | Learn more: https://bit.ly/3DWt82x This is a not to be missed event for Students & Trainees or those looking to supplement basic clinical pharmacology information previously not available to you. This is Part 1 of a 3-part webinar series. Attendees that complete all three components and take the post-event test will be awarded a certificate of completion and digital badge that can be shared on your social media accounts highlighting the skills you have obtained. We look forward to your participation and please share with your colleagues that may benefit from this webinar series!
The Journal of Clinical Pharmacology - November 2021, Vol 61, Issue 11 is now available! http://bit.ly/2Ijxci7 *Continuing Education: Review* Risk of Thrombocytopenia With Platelet-Derived Growth Factor Receptor Kinase Inhibitors in Cancer Patients: A Systematic Review and Meta-Analysis of Phase 2/3 Randomized, Controlled Trials Yuan Liu MS, Wenxia Sun MS, Jing Li MS Pages: 1397-1405 | First Published: 09 July 2021 *Editor's Choice: Therapeutics* Influence of Prednisone on Inflammatory Biomarkers in Community-Acquired Pneumonia: Secondary Analysis of a Randomized Trial Natalie Raess BMed, Philipp Schuetz MD, MPH, Nicole Cesana-Nigro MD, Bettina Winzeler MD, Sandrine A. Urwyler MD, Sabine Schaedelin MSc, Nicolas Rodondi MD, MAS, Manuel R. Blum MD, MSc, Matthias Briel MD, MSc, Beat Mueller MD, Mirjam Christ-Crain MD, PhD, Claudine A. Blum MD Pages: 1406-1414 | First Published: 25 May 2021 *Therapeutics* Cisatracurium Continuous Infusion Versus No Neuromuscular Blockade for Acute Respiratory Distress Syndrome on Venovenous Extracorporeal Membrane Oxygenation Christian Kressin PharmD, Melissa Thompson Bastin PharmD, PhD, Ayesha Ather PharmD, Anil Gopinath MD, Habib Srour MD, Aric Schadler PhD, Komal Pandya PharmD Pages: 1415-1420 | First Published: 28 June 2021 Ketamine for Refractory Chronic Migraine: An Observational Pilot Study and Metabolite Analysis Eric S. Schwenk MD, Marc C. Torjman PhD, Ruin Moaddel PhD, Jacqueline Lovett MS, Daniel Katz DO, William Denk MD, Clinton Lauritsen DO, Stephen D. Silberstein MD, Irving W. Wainer PhD Pages: 1421-1429 | First Published: 14 June 2021 *Pharmacometrics* Population Pharmacokinetics of Olanzapine and Samidorphan When Administered in Combination in Healthy Subjects and Patients With Schizophrenia Lei Sun PhD, Richard Mills PhD, Brian M. Sadler PhD, Bhaskar Rege PhD Pages: 1430-1441 | First Published: 21 May 2021 A Target-Mediated Drug Disposition Model to Explain Nonlinear Pharmacokinetics of the 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor SPI-62 in Healthy Adults Nan Wu MS, David A. Katz PhD, Guohua An MD, PhD Pages: 1442-1453 | First Published: 10 June 2021 *Special Populations* Pharmacokinetics of Asciminib in Individuals With Hepatic or Renal Impairment Matthias Hoch PhD, Masahiko Sato PhD, Julia Zack PharmD, Michelle Quinlan PhD, Tirtha Sengupta MSc, Alex Allepuz MD, Paola Aimone MD, Florence Hourcade-Potelleret PhD Pages: 1454-1465 | First Published: 11 June 2021 *Drug Development* Biperiden Challenge Model in Healthy Elderly as Proof-of-Pharmacology Tool: A Randomized, Placebo-Controlled Trial Charlotte Bakker MD, Michiel J. van Esdonk PhD, Rik (F). E. Stuurman PhD, Laura G.J.M. Borghans PhD, Marieke L. de Kam MSc, Joop M.A. van Gerven MD, PhD, Geert Jan Groeneveld MD, PhD Pages: 1466-1478 | First Published: 21 May 2021 *Pediatric Pharmacology* Methods for Detecting Pediatric Adverse Drug Reactions From the Electronic Medical Record Lydia M. Joyner MS, Leah A. Alicea, Jennifer L. Goldman MD, MS, Sarah L. Suppes PharmD, Emma M. Tillman PharmD, PhD Pages: 1479-1484 | First Published: 25 May 2021 A Clinical Decision Support Tool to Find the Best Initial Intravenous Cyclosporine Regimen in Pediatric Hematopoietic Stem Cell Transplantation Vincent Leclerc PharmD, Michel Ducher PharmD, Antony Ceraulo MD, Yves Bertrand MD, Nathalie Bleyzac PharmD Pages: 1485-1492 | First Published: 08 June 2021 Physiologically Based Pharmacokinetic Modeling for Selumetinib to Evaluate Drug-Drug Interactions and Pediatric Dose Regimens Sarit Cohen-Rabbie PhD, Li Zhou PhD, Karthick Vishwanathan PhD, Martin Wild PhD, Sherrie Xu PhD, Tomoko Freshwater PhD, Lokesh Jain PhD, Stein Schalkwijk PhD, PharmD, Helen Tomkinson MS, Diansong Zhou PhD Pages: 1493-1504 | First Published: 01 July 2021 *Physiologically Based Pharmacokinetic Modeling* Prediction of Fluoxetine and Norfluoxetine Pharmacokinetic Profiles Using Physiologically Based Pharmacokinetic Modeling Hyeon-Cheol Jeong MS, Yoon-Jee Chae PhD, Sooyeun Lee PhD, Wonku Kang PhD, Hwi-yeol Yun PhD, Kwang-Hee Shin PhD Pages: 1505-1513 | First Published: 12 June 2021