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,
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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 educational needs of its diverse membership and all healthcare professionals, covering a range of topics that span the entire area of the interaction between drugs and humans. These areas include, but are not limited to, pharmaceutical chemistry, biochemistry, drug metabolism, pharmacokinetics, pharmacodynamics, pharmacometrics, pharmacogenomics, clinical pharmacology practice in the outpatient and inpatient settings, human toxicology, drug interactions, and clinical drug trials. The diversity of the College is expressed not only in the composition of its membership, but also in its leadership. Maintaining a balance of elected Regents and Officers from all pertinent professional backgrounds ensures that the College remains attuned to the needs of all professionals engaged in the practice of or with a strong interest in clinical pharmacology, from the research laboratory (academic and industrial) to the classroom, and from the clinical trial to improved patient care.

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 educational needs of its diverse membership and all healthcare professionals, covering a range of topics that span the entire area of the interaction between drugs and humans. These areas include, but are not limited to, pharmaceutical chemistry, biochemistry, drug metabolism, pharmacokinetics, pharmacodynamics, pharmacometrics, pharmacogenomics, clinical pharmacology practice in the outpatient and inpatient settings, human toxicology, drug interactions, and clinical drug trials. The diversity of the College is expressed not only in the composition of its membership, but also in its leadership. Maintaining a balance of elected Regents and Officers from all pertinent professional backgrounds ensures that the College remains attuned to the needs of all professionals engaged in the practice of or with a strong interest in clinical pharmacology, from the research laboratory (academic and industrial) to the classroom, and from the clinical trial to improved patient care.

Operating as usual

05/06/2021
FDA Approves Bamlanivimab and Etesevimab for Treatment of COVID-19 | ACCP

FDA Approves ZYNLONTA for the Treatment of Adult Patients with Elapsed or Refractory Large B-Cell Lymphoma after Two or More Lines of Systemic Therapy

On April 23, 2021, the FDA approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

ZYNLONTA is administered as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks). The approved recommended dosage of ZYNLONTA is 0.15 mg/kg every 3 weeks for 2 cycles, then 0.075 mg/kg every 3 weeks for subsequent cycles. Patients should be premedicated with dexamethasone 4 mg orally or IV twice daily for 3 days beginning the day before administering ZYNLONTA. If dexamethasone administration does not start the day before ZYNLONTA, begin at least 2 hours prior to administration of ZYNLONTA.

Read more: https://bit.ly/3urhloH
#zynlonta #lymphoma

On February 9, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms....

ACCP is pleased to announce Dr. Luning (Ada) Zhuang as the recipient of the 2021 McKeen Cattell Memorial Award. The McKe...
05/06/2021

ACCP is pleased to announce Dr. Luning (Ada) Zhuang as the recipient of the 2021 McKeen Cattell Memorial Award. The McKeen Cattell Memorial Award is given in memory of the late McKeen Cattell, MD, PhD, FCP, the first editor of The Journal of Clinical Pharmacology (JCP) and co-founder of ACCP. This award is given annually, recognizing an outstanding research paper published in the JCP during the preceding year. The award is typically presented to the first author of the paper.

“Evaluation of Hemodialysis Effect on Pharmacokinetics of Meropenem/Vaborbactam in End-stage Renal Disease Patients Using Modeling and Simulation". Authors: Luning Zhuang, PhD, Yichao Yu, PhD, Xiaohui Wei, PhD, Jeffry Florian, PhD, Seong H Jang, PhD, Kellie S. Reynolds, PharmD and Yaning Wang, PhD. Published in The Journal of Clinical Pharmacology, Volume 60, Issue 8, pages 1011 – 1021, August, 2020.

Congratulations, Dr. Zhuang! We look forward to recognizing you for your achievements during the #2021ACCP Virtual Annual Meeting!

ACCP is pleased to announce Dr. Luning (Ada) Zhuang as the recipient of the 2021 McKeen Cattell Memorial Award. The McKeen Cattell Memorial Award is given in memory of the late McKeen Cattell, MD, PhD, FCP, the first editor of The Journal of Clinical Pharmacology (JCP) and co-founder of ACCP. This award is given annually, recognizing an outstanding research paper published in the JCP during the preceding year. The award is typically presented to the first author of the paper.

“Evaluation of Hemodialysis Effect on Pharmacokinetics of Meropenem/Vaborbactam in End-stage Renal Disease Patients Using Modeling and Simulation". Authors: Luning Zhuang, PhD, Yichao Yu, PhD, Xiaohui Wei, PhD, Jeffry Florian, PhD, Seong H Jang, PhD, Kellie S. Reynolds, PharmD and Yaning Wang, PhD. Published in The Journal of Clinical Pharmacology, Volume 60, Issue 8, pages 1011 – 1021, August, 2020.

Congratulations, Dr. Zhuang! We look forward to recognizing you for your achievements during the #2021ACCP Virtual Annual Meeting!

TWO WEEKS Until the May #ACCPVJC Webinar: Direct Oral to Parenteral Anticoagulants: Strategies for Inpatient Transition!...
05/05/2021

TWO WEEKS Until the May #ACCPVJC Webinar: Direct Oral to Parenteral Anticoagulants: Strategies for Inpatient Transition!

May 19th | 2:00 - 3:00 PM ET | Free Registration: http://bit.ly/ACCPVJC

This webinar will present a case study that describes the impact on bleeding rates of two different strategies for transitioning from a direct oral anticoagulant (DOAC) to a parenteral anticoagulant: a delayed, clinically-driven strategy vs the standard per package insert strategy. Don't miss this opportunity to learn current recommendations for transitioning between DOACs and parenteral anticoagulation and to explore evidence on alternative strategies.

Please share with your colleagues that may find this topic of interest!
#pharmacology #CME #CPE

Faculty: Chelsea N. Lopez, PharmD, BCCCP, Clinical Specialist, Houston Methodist Hosp

TWO WEEKS Until the May #ACCPVJC Webinar: Direct Oral to Parenteral Anticoagulants: Strategies for Inpatient Transition!

May 19th | 2:00 - 3:00 PM ET | Free Registration: http://bit.ly/ACCPVJC

This webinar will present a case study that describes the impact on bleeding rates of two different strategies for transitioning from a direct oral anticoagulant (DOAC) to a parenteral anticoagulant: a delayed, clinically-driven strategy vs the standard per package insert strategy. Don't miss this opportunity to learn current recommendations for transitioning between DOACs and parenteral anticoagulation and to explore evidence on alternative strategies.

Please share with your colleagues that may find this topic of interest!
#pharmacology #CME #CPE

Faculty: Chelsea N. Lopez, PharmD, BCCCP, Clinical Specialist, Houston Methodist Hosp

In ONE WEEK the ACCP STEP Webinar: Communicating Your Science: Acing Presentations & Posters at Conferences will begin. ...
05/05/2021

In ONE WEEK the ACCP STEP Webinar: Communicating Your Science: Acing Presentations & Posters at Conferences will begin. Secure your seat today!

May 12th | 2:00 PM ET | Free Registration: https://bit.ly/3wanPcP

Effective presentation and communication of your scientific research are critical skills for any scientist in the field of clinical pharmacology. This often-overlooked skill set can be challenging to develop and become an expert in; however, with a few tried and true strategies, you can effectively communicate your science and impress your audience. Register today to learn effective strategies on how to present your research at virtual and in-person educational events.
#pharmacology #CME #CPE

Faculty:
Matthew B. Dufek PhD, Sr Director of Clinical Development – Neuroscience Therapeutic Area, AbbVie Inc

Alexander J. Prokopienko, PharmD, PhD, Senior Clinical Pharmacologist, Quantitative Clinical Pharmacology, Takeda Pharmaceuticals USA Inc

In ONE WEEK the ACCP STEP Webinar: Communicating Your Science: Acing Presentations & Posters at Conferences will begin. Secure your seat today!

May 12th | 2:00 PM ET | Free Registration: https://bit.ly/3wanPcP

Effective presentation and communication of your scientific research are critical skills for any scientist in the field of clinical pharmacology. This often-overlooked skill set can be challenging to develop and become an expert in; however, with a few tried and true strategies, you can effectively communicate your science and impress your audience. Register today to learn effective strategies on how to present your research at virtual and in-person educational events.
#pharmacology #CME #CPE

Faculty:
Matthew B. Dufek PhD, Sr Director of Clinical Development – Neuroscience Therapeutic Area, AbbVie Inc

Alexander J. Prokopienko, PharmD, PhD, Senior Clinical Pharmacologist, Quantitative Clinical Pharmacology, Takeda Pharmaceuticals USA Inc

The Journal of Clinical Pharmacology - May 2021, Vol 61, Issue 5 is now available!*Continuing Education: Review*Antiretr...
05/04/2021

The Journal of Clinical Pharmacology - May 2021, Vol 61, Issue 5 is now available!

*Continuing Education: Review*
Antiretrovirals for Prophylaxis Against COVID‐19: A Comprehensive Literature Review
Golbarg Alavian PharmD, Kasra Kolahdouzan MD, Masoud Mortezazadeh MD, Zahra Sadat Torabi DDS
Pages: 581-590 | First Published: 20 November 2020

*Editor's Choice: Therapeutics*
Days Needed for the Disappearance of a Cough Due to the Use of an Angiotensin‐Converting Enzyme Inhibitor and Identification of Predisposing Factors Associated With Its Appearance in a Clinical Cohort of Hypertensive Patients
Manuel Fernandez‐Rando MSc, María Dolores Herrera PhD, Carmen V. Almeida‐González PhD, Antonio Grilo MD
Pages: 591-597 | First Published: 14 November 2020

*Therapeutics*
Outcomes Associated With 4‐Factor Prothrombin Complex Concentrate Administration to Reverse Oral Factor Xa Inhibitors in Bleeding Patients
Emily A. Highsmith PharmD, Celia Morton PharmD, Sara Varnado PharmD, Kevin R. Donahue PharmD, Suraj Sulhan MD, Annette Lista PharmD
Pages: 598-605 | First Published: 23 October 2020

Prediction of Fracture Risk From Early‐Stage Bone Markers in Patients With Osteoporosis Treated With Once‐Yearly Administered Zoledronic Acid
Hidefumi Kasai BS, Yoko Mori MS, Atsushi Ose PhD, Masataka Shiraki MD, PhD, Yusuke Tanigawara PhD
Pages: 606-613 | First Published: 01 November 2020

*Exposure Response*
Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients
Man (Melody) Luo PhD, Saad Z. Usmani MD, Maria‐Victoria Mateos MD, PhD, Hareth Nahi MD, PhD, Ajai Chari MD, Jesus San‐Miguel MD, PhD, Cyrille Touzeau MD, PhD, Kenshi Suzuki MD, PhD, Martin Kaiser MD, Robin Carson MD, Christoph Heuck MD, Ming Qi MD, PhD, Honghui Zhou PhD, Yu‐Nien Sun PhD, Dolly A. Parasrampuria PhD
Pages: 614-627 | First Published: 03 November 2020

Exposure‐Response Analyses for Upadacitinib Efficacy in Subjects With Atopic Dermatitis—Analyses of Phase 2b Study to Support Selection of Phase 3 Doses
Mohamed‐Eslam F. Mohamed PhD, FCP, Sathej Gopalakrishnan PhD, Henrique D. Teixeira PhD, Ahmed A. Othman PhD, FCP
Pages: 628-635 | First Published: 06 November 2020

*Pharmacodynamics*
Predicted Cardiac Hemodynamic Consequences of the Renal Actions of SGLT2i in the DAPA‐HF Study Population: A Mathematical Modeling Analysis
Hongtao Yu PhD, Weifeng Tang PhD, Peter J. Greasley PhD, Robert C. Penland PhD, David W. Boulton PhD, K. Melissa Hallow PhD
Pages: 636-648 | First Published: 22 October 2020

*Metabolomics*
Effects of Continuous Albuterol Inhalation on Serum Metabolome in Healthy Subjects: More Than Just Lactic Acid
Craig D. Nowadly MD, Shu‐Yi Liao MD, ScD, John S. Rose MD
Pages: 649-655 | First Published: 30 October 2020

*Physiologically Based Pharmacokinetic Modeling*
Applications of Physiologically Based Pharmacokinetic Modeling of Rivaroxaban—Renal and Hepatic Impairment and Drug‐Drug Interaction Potential
Stefan Willmann PhD, Katrin Coboeken PhD, Stefanie Kapsa PhD, Kirstin Thelen PhD, Markus Mundhenke MD, Kerstin Fischer PhD, Burkhard Hügl MD, Wolfgang Mück PhD
Pages: 656-665 | First Published: 17 November 2020

*Pediatric Pharmacology*
Pharmacokinetics and Optimal Dose Selection of Cefazolin for Surgical Prophylaxis of Pediatric Patients
Michael L. Schmitz MD, Christopher M. Rubino PharmD, Nikolas J. Onufrak PharmD, Diana Valencia Martinez MD, MSc, Diane Licursi BS, Angela Karpf MD, Wes Cetnarowski MD, BCMAS
Pages: 666-676 | First Published: 17 November 2020

Dosing Recommendations for Lamotrigine in Children: Evaluation Based on Previous and New Population Pharmacokinetic Models
Manon Tauzin MD, Jean‐Marc Tréluyer MD, PhD, Rima Nabbout MD, PhD, Thierry Billette de Villemeur MD, PhD, Isabelle Desguerre MD, PhD, Radia Aboura PharmD, Ines Gana PharmD, PhD, Yi Zheng MSc, Sihem Benaboud PharmD, PhD, Naim Bouazza PhD, Camille Chenevier‐Gobeaux PharmD, Cécile Freihuber MD, Déborah Hirt PharmD, PhD
Pages: 677-687 | First Published: 26 November 2020

Model‐Based Selection and Recommendation for Subcutaneous Abatacept Dose in Patients With Polyarticular Juvenile Idiopathic Arthritis
Yash Gandhi PhD, Julie A. Passarell MA, Amit Roy PhD, Bindu Murthy PharmD
Pages: 688-699 | First Published: 07 December 2020

*Women's Health*
Population PK‐PD‐PD Modeling of Recombinant Follicle Stimulating Hormone in In Vitro Fertilization/Intracytoplasmic S***m Injection: Implications on Dosing and Timing of Gonadotrophin Therapy
Abdel Hameed I. M. Ebid PhD, Sara M. Abdel Motaleb PhD, Mahmoud I. Mostafa MSc, Mahmoud M. A. Soliman PhD
Pages: 700-713 | First Published: 04 December 2020

*Pharmacokinetics/Pharmacodynamics*
Differential Binding of Sarilumab and Tocilizumab to IL‐6Rα and Effects of Receptor Occupancy on Clinical Parameters
Christine Xu PhD, Ashique Rafique MSc, Terra Potocky PhD, Anne Paccaly PharmD, PhD, FCP, Patrick Nolain MSci, Qiang Lu PhD, Melitza Iglesias‐Rodriguez MD, Gregory St John PhD, Michael C. Nivens PhD, Vanaja Kanamaluru PhD, Jeanette Fairhurst BA, Tomonori Ishii MD, Rafael Maldonado MD, PhD, Ernest Choy MD, Paul Emery MD, FRCP, FMedSci
Pages: 714-724 | First Published: 12 December 2020
http://bit.ly/2Ijxci7

The Journal of Clinical Pharmacology - May 2021, Vol 61, Issue 5 is now available!

*Continuing Education: Review*
Antiretrovirals for Prophylaxis Against COVID‐19: A Comprehensive Literature Review
Golbarg Alavian PharmD, Kasra Kolahdouzan MD, Masoud Mortezazadeh MD, Zahra Sadat Torabi DDS
Pages: 581-590 | First Published: 20 November 2020

*Editor's Choice: Therapeutics*
Days Needed for the Disappearance of a Cough Due to the Use of an Angiotensin‐Converting Enzyme Inhibitor and Identification of Predisposing Factors Associated With Its Appearance in a Clinical Cohort of Hypertensive Patients
Manuel Fernandez‐Rando MSc, María Dolores Herrera PhD, Carmen V. Almeida‐González PhD, Antonio Grilo MD
Pages: 591-597 | First Published: 14 November 2020

*Therapeutics*
Outcomes Associated With 4‐Factor Prothrombin Complex Concentrate Administration to Reverse Oral Factor Xa Inhibitors in Bleeding Patients
Emily A. Highsmith PharmD, Celia Morton PharmD, Sara Varnado PharmD, Kevin R. Donahue PharmD, Suraj Sulhan MD, Annette Lista PharmD
Pages: 598-605 | First Published: 23 October 2020

Prediction of Fracture Risk From Early‐Stage Bone Markers in Patients With Osteoporosis Treated With Once‐Yearly Administered Zoledronic Acid
Hidefumi Kasai BS, Yoko Mori MS, Atsushi Ose PhD, Masataka Shiraki MD, PhD, Yusuke Tanigawara PhD
Pages: 606-613 | First Published: 01 November 2020

*Exposure Response*
Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients
Man (Melody) Luo PhD, Saad Z. Usmani MD, Maria‐Victoria Mateos MD, PhD, Hareth Nahi MD, PhD, Ajai Chari MD, Jesus San‐Miguel MD, PhD, Cyrille Touzeau MD, PhD, Kenshi Suzuki MD, PhD, Martin Kaiser MD, Robin Carson MD, Christoph Heuck MD, Ming Qi MD, PhD, Honghui Zhou PhD, Yu‐Nien Sun PhD, Dolly A. Parasrampuria PhD
Pages: 614-627 | First Published: 03 November 2020

Exposure‐Response Analyses for Upadacitinib Efficacy in Subjects With Atopic Dermatitis—Analyses of Phase 2b Study to Support Selection of Phase 3 Doses
Mohamed‐Eslam F. Mohamed PhD, FCP, Sathej Gopalakrishnan PhD, Henrique D. Teixeira PhD, Ahmed A. Othman PhD, FCP
Pages: 628-635 | First Published: 06 November 2020

*Pharmacodynamics*
Predicted Cardiac Hemodynamic Consequences of the Renal Actions of SGLT2i in the DAPA‐HF Study Population: A Mathematical Modeling Analysis
Hongtao Yu PhD, Weifeng Tang PhD, Peter J. Greasley PhD, Robert C. Penland PhD, David W. Boulton PhD, K. Melissa Hallow PhD
Pages: 636-648 | First Published: 22 October 2020

*Metabolomics*
Effects of Continuous Albuterol Inhalation on Serum Metabolome in Healthy Subjects: More Than Just Lactic Acid
Craig D. Nowadly MD, Shu‐Yi Liao MD, ScD, John S. Rose MD
Pages: 649-655 | First Published: 30 October 2020

*Physiologically Based Pharmacokinetic Modeling*
Applications of Physiologically Based Pharmacokinetic Modeling of Rivaroxaban—Renal and Hepatic Impairment and Drug‐Drug Interaction Potential
Stefan Willmann PhD, Katrin Coboeken PhD, Stefanie Kapsa PhD, Kirstin Thelen PhD, Markus Mundhenke MD, Kerstin Fischer PhD, Burkhard Hügl MD, Wolfgang Mück PhD
Pages: 656-665 | First Published: 17 November 2020

*Pediatric Pharmacology*
Pharmacokinetics and Optimal Dose Selection of Cefazolin for Surgical Prophylaxis of Pediatric Patients
Michael L. Schmitz MD, Christopher M. Rubino PharmD, Nikolas J. Onufrak PharmD, Diana Valencia Martinez MD, MSc, Diane Licursi BS, Angela Karpf MD, Wes Cetnarowski MD, BCMAS
Pages: 666-676 | First Published: 17 November 2020

Dosing Recommendations for Lamotrigine in Children: Evaluation Based on Previous and New Population Pharmacokinetic Models
Manon Tauzin MD, Jean‐Marc Tréluyer MD, PhD, Rima Nabbout MD, PhD, Thierry Billette de Villemeur MD, PhD, Isabelle Desguerre MD, PhD, Radia Aboura PharmD, Ines Gana PharmD, PhD, Yi Zheng MSc, Sihem Benaboud PharmD, PhD, Naim Bouazza PhD, Camille Chenevier‐Gobeaux PharmD, Cécile Freihuber MD, Déborah Hirt PharmD, PhD
Pages: 677-687 | First Published: 26 November 2020

Model‐Based Selection and Recommendation for Subcutaneous Abatacept Dose in Patients With Polyarticular Juvenile Idiopathic Arthritis
Yash Gandhi PhD, Julie A. Passarell MA, Amit Roy PhD, Bindu Murthy PharmD
Pages: 688-699 | First Published: 07 December 2020

*Women's Health*
Population PK‐PD‐PD Modeling of Recombinant Follicle Stimulating Hormone in In Vitro Fertilization/Intracytoplasmic S***m Injection: Implications on Dosing and Timing of Gonadotrophin Therapy
Abdel Hameed I. M. Ebid PhD, Sara M. Abdel Motaleb PhD, Mahmoud I. Mostafa MSc, Mahmoud M. A. Soliman PhD
Pages: 700-713 | First Published: 04 December 2020

*Pharmacokinetics/Pharmacodynamics*
Differential Binding of Sarilumab and Tocilizumab to IL‐6Rα and Effects of Receptor Occupancy on Clinical Parameters
Christine Xu PhD, Ashique Rafique MSc, Terra Potocky PhD, Anne Paccaly PharmD, PhD, FCP, Patrick Nolain MSci, Qiang Lu PhD, Melitza Iglesias‐Rodriguez MD, Gregory St John PhD, Michael C. Nivens PhD, Vanaja Kanamaluru PhD, Jeanette Fairhurst BA, Tomonori Ishii MD, Rafael Maldonado MD, PhD, Ernest Choy MD, Paul Emery MD, FRCP, FMedSci
Pages: 714-724 | First Published: 12 December 2020
http://bit.ly/2Ijxci7

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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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Friday 08:00 - 17:00

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