American College of Clinical Pharmacology

07/08/2021

New at the #2021ACCP Virtual Annual Meeting is a Regulatory Symposium, "Clinical Pharmacology Regulatory Considerations for Recent Oncology Approvals". You won't want to miss this Symposium as Faculty Speakers discuss the clinical pharmacology considerations that go into the approval of select drugs & the implications of these decisions in patient care. Secure your seat today: https://bit.ly/3iB7Cqe
#pharmacology #CME #CPE #conference

New at the #2021ACCP Virtual Annual Meeting is a Regulatory Symposium, "Clinical Pharmacology Regulatory Considerations for Recent Oncology Approvals". You won't want to miss this Symposium as Faculty Speakers discuss the clinical pharmacology considerations that go into the approval of select drugs & the implications of these decisions in patient care. Secure your seat today: https://bit.ly/3iB7Cqe
#pharmacology #CME #CPE #conference

07/08/2021

www.accessdata.fda.gov

On June 30, 2021, the US Food & Drug Administration approved RYLAZE [asparaginase erwinia chrysanthemi (recombinant)-rywn] as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

The recommended dosage of RYLAZE when replacing a long-acting asparaginase product is 25 mg/m2 intramuscularly (IM) every 48 hours (Q48H). Monitor patient’s bilirubin, transaminases, glucose, and clinical examinations prior to treatment every 2-3 weeks and as indicated clinically, and until recovery from the cycle of therapy if results are abnormal.

Additional information regarding dosage and administration as well as warnings and precautions about hypersensitivity reactions, pancreatitis, thrombosis, hemorrhage, and hepatotoxicity can be found here: https://bit.ly/3AI04ej
#FDA #rylaze #leukemia #lymphoma

07/08/2021

The ACCP "Excellence in Achievement" Program is pleased to recognize Alexander J. Prokopienko, PharmD, PhD, Senior Clinical Pharmacologist, Quantitative Clinical Pharmacology – Data Sciences Inst, at Takeda Pharmaceuticals USA Inc. Dr. Prokopienko joined ACCP as a Student Member in 2013 and became a Full Member in 2019. He is currently Co-chair of the Student, Trainee & Early-stage Professional Committee of which he has been an active member since 2016. Dr. Prokopienko is also a member of the Working Group on Early-stage Professionals and previously served on the Working Group on Future Annual Meetings. He was a member of the Education Committee from 2018 - 2020. In addition to his committee participation, Dr. Prokopienko has been a Moderator on numerous webinars and most recently as a Faculty Speaker on Communicating Your Science: Acing Presentations & Posters at Conferences webinar. He was a Poster Presenter at the 2013 ACCP Annual Meeting and was a Student & Trainee Abstract Award Winner in 2018. Dr. Prokopienko has been a fervent supporter of ACCP since joining and we look forward to his continued involvement in the society!

Dr. Prokopienko earned his PharmD in 2014 from Albany Coll of Pharmacy in Albany, NY and his PhD in Clinical Pharmaceutical Sciences from Univ of Pittsburgh School of Pharmacy in Pittsburgh, PA in 2019. From 2016 - 2018, he received a National Inst of Health (NIH) Training Grant for a NIH Postdoctoral Fellowship in Clinical & Translational Science at the Univ of Pittsburgh School of Medicine. Dr. Prokopienko secured his first full-time position as a Clinical Pharmacologist, Translational Medicine - Clinical Pharmacology at Vertex Pharmaceuticals Inc in 2019. He has received numerous awards and has co-authored many publications and presented posters at non-profit and academic institutions.

Dr. Prokopienko graciously shared his thoughts on what ACCP membership means to him:

"I became a Student Member of ACCP as a pharmacy student, was actively involved throughout my PhD studies and I continue to benefit personally and professionally from membership as an Early-stage Professional. ACCP offers professional development opportunities to all career stages. As a pharmacy student, I presented one of my first Posters at an ACCP Annual Meeting and distinctly remember the Editor-in-Chief of The Journal of Clinical Pharmacology, Dr. Joe Bertino, stopping at my poster to discuss the results. His interest in my Poster is a great example of the personal and humanistic approach that ACCP shows to all Members. Membership in ACCP has also supported my professional development through opportunities to serve and now Co-chair the Student, Trainee and Early-stage Professional Committee. Additionally, I highly value the Annual Meeting Symposia, other numerous opportunities to obtain CE, such as webinars, the mentoring program and various membership benefits. If you’re a Student, Trainee, Early-stage Professional or mid-career professional looking for opportunities to advance your career, definitely consider joining ACCP – I’m glad that I did!"

Congratulations, Dr. Prokopienko, on being recognized for your outstanding achievements and contributions to ACCP!

The ACCP "Excellence in Achievement" Program is pleased to recognize Alexander J. Prokopienko, PharmD, PhD, Senior Clinical Pharmacologist, Quantitative Clinical Pharmacology – Data Sciences Inst, at Takeda Pharmaceuticals USA Inc. Dr. Prokopienko joined ACCP as a Student Member in 2013 and became a Full Member in 2019. He is currently Co-chair of the Student, Trainee & Early-stage Professional Committee of which he has been an active member since 2016. Dr. Prokopienko is also a member of the Working Group on Early-stage Professionals and previously served on the Working Group on Future Annual Meetings. He was a member of the Education Committee from 2018 - 2020. In addition to his committee participation, Dr. Prokopienko has been a Moderator on numerous webinars and most recently as a Faculty Speaker on Communicating Your Science: Acing Presentations & Posters at Conferences webinar. He was a Poster Presenter at the 2013 ACCP Annual Meeting and was a Student & Trainee Abstract Award Winner in 2018. Dr. Prokopienko has been a fervent supporter of ACCP since joining and we look forward to his continued involvement in the society!

Dr. Prokopienko earned his PharmD in 2014 from Albany Coll of Pharmacy in Albany, NY and his PhD in Clinical Pharmaceutical Sciences from Univ of Pittsburgh School of Pharmacy in Pittsburgh, PA in 2019. From 2016 - 2018, he received a National Inst of Health (NIH) Training Grant for a NIH Postdoctoral Fellowship in Clinical & Translational Science at the Univ of Pittsburgh School of Medicine. Dr. Prokopienko secured his first full-time position as a Clinical Pharmacologist, Translational Medicine - Clinical Pharmacology at Vertex Pharmaceuticals Inc in 2019. He has received numerous awards and has co-authored many publications and presented posters at non-profit and academic institutions.

Dr. Prokopienko graciously shared his thoughts on what ACCP membership means to him:

"I became a Student Member of ACCP as a pharmacy student, was actively involved throughout my PhD studies and I continue to benefit personally and professionally from membership as an Early-stage Professional. ACCP offers professional development opportunities to all career stages. As a pharmacy student, I presented one of my first Posters at an ACCP Annual Meeting and distinctly remember the Editor-in-Chief of The Journal of Clinical Pharmacology, Dr. Joe Bertino, stopping at my poster to discuss the results. His interest in my Poster is a great example of the personal and humanistic approach that ACCP shows to all Members. Membership in ACCP has also supported my professional development through opportunities to serve and now Co-chair the Student, Trainee and Early-stage Professional Committee. Additionally, I highly value the Annual Meeting Symposia, other numerous opportunities to obtain CE, such as webinars, the mentoring program and various membership benefits. If you’re a Student, Trainee, Early-stage Professional or mid-career professional looking for opportunities to advance your career, definitely consider joining ACCP – I’m glad that I did!"

Congratulations, Dr. Prokopienko, on being recognized for your outstanding achievements and contributions to ACCP!

07/07/2021

ACCP is pleased to announce the release of the *Pediatric Dose Selection Supplement* in The Journal of Clinical Pharmacology, Volume 61, Issue S1. Guest Editors: Drs. Gilbert J. Burckart, John N. van den Anker.

We encourage you to share the Supplement with your colleagues that may find this of interest.
https://bit.ly/3r1Xxrb
#pediatric #dose #selection #pharmacology #drugdevelopment #PBPK #neonatology

ACCP is pleased to announce the release of the *Pediatric Dose Selection Supplement* in The Journal of Clinical Pharmacology, Volume 61, Issue S1. Guest Editors: Drs. Gilbert J. Burckart, John N. van den Anker.

We encourage you to share the Supplement with your colleagues that may find this of interest.
https://bit.ly/3r1Xxrb
#pediatric #dose #selection #pharmacology #drugdevelopment #PBPK #neonatology

07/06/2021

The Journal of Clinical Pharmacology - July 2021, Vol 61, Issue 7 is now available!
http://bit.ly/2Ijxci7

*Commentary*
Patient‐Reported Outcomes: Listening for What Is Most Important in Clinical Care and Patient‐Focused Drug Development
Barbara Ameer PharmD, MBA, BCPS, FCP
Pages: 845-847 | First Published: 04 April 2021

*Continuing Education: Review*
Fever Associated With Dexmedetomidine in Adult Acute Care Patients: A Systematic Review of the Literature
James W. Schurr PharmD, Lara Ambrosi BS, Jordan L. Lastra MS, Kevin C. McLaughlin PharmD, Gaspar Hacobian PharmD, Paul M. Szumita PharmD
Pages: 848-856 | First Published: 07 February 2021

*Editor's Choice: Review: Pediatric Pharmacology*
Opioid Treatment for Neonatal Opioid Withdrawal Syndrome: Current Challenges and Future Approaches
Brooks T. McPhail PhD, Chie Emoto PhD, Dawn Butler PharmD, Tsuyoshi Fukuda PhD, Henry Akinbi MD, Alexander A. Vinks PharmD, PhD, FCP
Pages: 857-870 | First Published: 31 December 2020

*Pediatric Pharmacology*
Association of Urine Platinum With Acute Kidney Injury in Children Treated With Cisplatin for Cancer
Asaf Lebel MD, Hayton Chui, Kelly R. McMahon BSc, Yong Jin Lim PhD, Joseph Macri PhD, Stella Wang MSc, Prasad Devarajan MD, Tom D. Blydt-Hansen MD, Michael Zappitelli MD, MSc, Bradley L. Urquhart PhD
Pages: 871-880 | First Published: 18 February 2021

Use of Real‐World Data and Pharmacometric Modeling in Support of Lacosamide Dosing in Pediatric Patients Under 4 Years of Age
Pradeep B. Lukka PhD, Megan Woods PharmD, Rebecca Chhim PharmD, Stephanie J. Phelps PharmD, James W. Wheless MD, Bernd Meibohm PhD, FCP
Pages: 881-888 | First Published: 18 February 2021

Population Pharmacokinetic Analysis of Recombinant Factor VIII Fc Fusion Protein in Subjects With Severe Hemophilia A: Expanded to Include Pediatric Subjects
Suresh Katragadda PhD, Srividya Neelakantan PhD, Lei Diao PhD, Nancy Wong PhD
Pages: 889-900 | First Published: 14 March 2021

*Pharmacokinetics/Pharmacodynamics*
Pharmacokinetic and Pharmacodynamic Modeling of Tezepelumab to Guide Phase 3 Dose Selection for Patients With Severe Asthma
Neang Ly PhD, Yanan Zheng PhD, Janet M. Griffiths PhD, Rene van der Merwe MBChB, Balaji Agoram PhD, Jane R. Parnes MD, Lorin Roskos PhD
Pages: 901-912 | First Published: 28 December 2020

Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects
Jong-Lyul Ghim MD, PhD, May Chien Chin MD, MS, Jinah Jung MD, PhD, Jiwon Lee MS, Seokuee Kim MD, PhD, Bongtae Kim DVM, PhD, Geun Seog Song DVM, PhD, Young-Kyung Choi MS, Jae-Gook Shin MD, PhD
Pages: 913-922 | First Published: 20 December 2020

*Special Populations*
Phase 1 Renal Impairment Trial Results Supports Targeted Individualized Dosing of ELX‐02 in Patients With Nephropathic Cystinosis
Thomas Haverty MD, David J. Wyatt MD, Kaela M. Porter BS, Andi Leubitz MACPR, Kate Banks MA, Paul Goodyer MD, Ming-Yi Hu PhD
Pages: 923-931 | First Published: 23 December 2020

Effect of Renal Function Impairment on the Pharmacokinetics, Safety, and Tolerability of the Iminosugar Sinbaglustat
Meggane Melchior PhD, Jasper Dingemanse PharmD, PhD, Abir Alatrach MD, PhD, Thorsten Feldkamp MD, Patricia N. Sidharta PharmD, PhD, Martine Géhin PhD
Pages: 932-938 | First Published: 23 December 2020

Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Temsavir, the Active Moiety of Fostemsavir
Mindy Magee PharmD, Jill Slater PharmD, Frank Mannino PhD, Peter Ackerman MD, Cyril Llamoso MD, Katy Moore PharmD
Pages: 939-953 | First Published: 28 December 2020

Effect of Hepatic Impairment on the Pharmacokinetics of Itacitinib
April M. Barbour PhD, Kevin Rockich PhD, Evan Cimino BS, Gongfu Zhou PhD, Caterina Leonetti-Whalen MPH, Xuejun Chen PhD, Swamy Yeleswaram PhD, Noam Epstein MD, Naresh Punwani PhD
Pages: 954-960 | First Published: 12 January 2021

*Pharmacokinetics*
A Population Pharmacokinetic Model of (R)‐ and (S‐) Oxybutynin and Its Active Metabolites After Oral and Intravesical Administration to Healthy Volunteers
Melanie Kretschmar PharmD, Ahmed Abbas Suleiman PhD, Petra Krause MD, Uwe Albrecht MD, Raimund Stein MD, Peter Rubenwolf MD, Uwe Fuhr MD, Max Taubert MD
Pages: 961-971 | First Published: 28 December 2020

*Therapeutics*
Isoniazid Therapeutic Drug Monitoring in Tunisian Patients With Tuberculosis
Mohammed Alshaikheid PharmD, Haifa Ben Romdhane MD, Nadia Ben Fredj MD, Najah Ben Fadhel MD, Abir Aouam MD, Zohra Chadli MD, Naceur Boughattas PhD, Amel Chaabane MD, Karim Aouam MD, PhD
Pages: 972-978 | First Published: 05 January 2021

*Correction*
Correction
Pages: 979-980 | First Published: 14 June 2021
This article is a correction.

The Journal of Clinical Pharmacology - July 2021, Vol 61, Issue 7 is now available!
http://bit.ly/2Ijxci7

*Commentary*
Patient‐Reported Outcomes: Listening for What Is Most Important in Clinical Care and Patient‐Focused Drug Development
Barbara Ameer PharmD, MBA, BCPS, FCP
Pages: 845-847 | First Published: 04 April 2021

*Continuing Education: Review*
Fever Associated With Dexmedetomidine in Adult Acute Care Patients: A Systematic Review of the Literature
James W. Schurr PharmD, Lara Ambrosi BS, Jordan L. Lastra MS, Kevin C. McLaughlin PharmD, Gaspar Hacobian PharmD, Paul M. Szumita PharmD
Pages: 848-856 | First Published: 07 February 2021

*Editor's Choice: Review: Pediatric Pharmacology*
Opioid Treatment for Neonatal Opioid Withdrawal Syndrome: Current Challenges and Future Approaches
Brooks T. McPhail PhD, Chie Emoto PhD, Dawn Butler PharmD, Tsuyoshi Fukuda PhD, Henry Akinbi MD, Alexander A. Vinks PharmD, PhD, FCP
Pages: 857-870 | First Published: 31 December 2020

*Pediatric Pharmacology*
Association of Urine Platinum With Acute Kidney Injury in Children Treated With Cisplatin for Cancer
Asaf Lebel MD, Hayton Chui, Kelly R. McMahon BSc, Yong Jin Lim PhD, Joseph Macri PhD, Stella Wang MSc, Prasad Devarajan MD, Tom D. Blydt-Hansen MD, Michael Zappitelli MD, MSc, Bradley L. Urquhart PhD
Pages: 871-880 | First Published: 18 February 2021

Use of Real‐World Data and Pharmacometric Modeling in Support of Lacosamide Dosing in Pediatric Patients Under 4 Years of Age
Pradeep B. Lukka PhD, Megan Woods PharmD, Rebecca Chhim PharmD, Stephanie J. Phelps PharmD, James W. Wheless MD, Bernd Meibohm PhD, FCP
Pages: 881-888 | First Published: 18 February 2021

Population Pharmacokinetic Analysis of Recombinant Factor VIII Fc Fusion Protein in Subjects With Severe Hemophilia A: Expanded to Include Pediatric Subjects
Suresh Katragadda PhD, Srividya Neelakantan PhD, Lei Diao PhD, Nancy Wong PhD
Pages: 889-900 | First Published: 14 March 2021

*Pharmacokinetics/Pharmacodynamics*
Pharmacokinetic and Pharmacodynamic Modeling of Tezepelumab to Guide Phase 3 Dose Selection for Patients With Severe Asthma
Neang Ly PhD, Yanan Zheng PhD, Janet M. Griffiths PhD, Rene van der Merwe MBChB, Balaji Agoram PhD, Jane R. Parnes MD, Lorin Roskos PhD
Pages: 901-912 | First Published: 28 December 2020

Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects
Jong-Lyul Ghim MD, PhD, May Chien Chin MD, MS, Jinah Jung MD, PhD, Jiwon Lee MS, Seokuee Kim MD, PhD, Bongtae Kim DVM, PhD, Geun Seog Song DVM, PhD, Young-Kyung Choi MS, Jae-Gook Shin MD, PhD
Pages: 913-922 | First Published: 20 December 2020

*Special Populations*
Phase 1 Renal Impairment Trial Results Supports Targeted Individualized Dosing of ELX‐02 in Patients With Nephropathic Cystinosis
Thomas Haverty MD, David J. Wyatt MD, Kaela M. Porter BS, Andi Leubitz MACPR, Kate Banks MA, Paul Goodyer MD, Ming-Yi Hu PhD
Pages: 923-931 | First Published: 23 December 2020

Effect of Renal Function Impairment on the Pharmacokinetics, Safety, and Tolerability of the Iminosugar Sinbaglustat
Meggane Melchior PhD, Jasper Dingemanse PharmD, PhD, Abir Alatrach MD, PhD, Thorsten Feldkamp MD, Patricia N. Sidharta PharmD, PhD, Martine Géhin PhD
Pages: 932-938 | First Published: 23 December 2020

Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Temsavir, the Active Moiety of Fostemsavir
Mindy Magee PharmD, Jill Slater PharmD, Frank Mannino PhD, Peter Ackerman MD, Cyril Llamoso MD, Katy Moore PharmD
Pages: 939-953 | First Published: 28 December 2020

Effect of Hepatic Impairment on the Pharmacokinetics of Itacitinib
April M. Barbour PhD, Kevin Rockich PhD, Evan Cimino BS, Gongfu Zhou PhD, Caterina Leonetti-Whalen MPH, Xuejun Chen PhD, Swamy Yeleswaram PhD, Noam Epstein MD, Naresh Punwani PhD
Pages: 954-960 | First Published: 12 January 2021

*Pharmacokinetics*
A Population Pharmacokinetic Model of (R)‐ and (S‐) Oxybutynin and Its Active Metabolites After Oral and Intravesical Administration to Healthy Volunteers
Melanie Kretschmar PharmD, Ahmed Abbas Suleiman PhD, Petra Krause MD, Uwe Albrecht MD, Raimund Stein MD, Peter Rubenwolf MD, Uwe Fuhr MD, Max Taubert MD
Pages: 961-971 | First Published: 28 December 2020

*Therapeutics*
Isoniazid Therapeutic Drug Monitoring in Tunisian Patients With Tuberculosis
Mohammed Alshaikheid PharmD, Haifa Ben Romdhane MD, Nadia Ben Fredj MD, Najah Ben Fadhel MD, Abir Aouam MD, Zohra Chadli MD, Naceur Boughattas PhD, Amel Chaabane MD, Karim Aouam MD, PhD
Pages: 972-978 | First Published: 05 January 2021

*Correction*
Correction
Pages: 979-980 | First Published: 14 June 2021
This article is a correction.