American College of Clinical Pharmacology

03/04/2020

accp1.org

ACCP is pleased to announce the publication of “Inclusion of Adolescents With Adults in Phase 3 Clinical Trials: Overview of the Current State and a Call for Action,” in ACCP’s The Journal of Clinical Pharmacology.
http://bit.ly/2uWVhZA

The primary objective of drug development from industry and regulatory perspectives is to enable patients’ access to safe and efficacious treatments in a timely manner. This objective is typically achieved through demonstrating efficacy and safety of novel pharmacological compounds in pivotal clinical trials. Currently, if a disease occurs in both pediatric and adult populations, a drug to treat such disease is usually evaluated first in adult phase 3 clinical trials before clinical trials are initiated in the pediatric population. Adolescent patients (defined as 12 to

03/04/2020

⚠️ Only One Week ⚠️ until the March #ACCPVJC Webinar: Real‐World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol Extended‐Release Case Study

Wednesday, March 11, 2020 @ 2:00 PM ET
Faculty: Joshua Brown, PharmD, PhD, Assistant Professor, Dept of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy
Register today! http://bit.ly/ACCPVJC

03/03/2020

The Journal of Clinical Pharmacology - March 2020, Vol 60, Issue 3 is now available!

Commentary
What Drug Development Sponsors, Contract Research Organizations, and Investigators Can Do to Increase Diversity in Clinical Trials
Yael Rose Symes PhD, Jack G. Modell MD
Pages: 281-283 | First Published: 13 October 2019

Core Entrustables In Clinical Pharmacology: Pearls For Clinical Practice
How to Prescribe Drugs With an Identified Proarrhythmic Liability
Munveer Thind MD, Ignacio Rodriguez MD, Sam Kosari BPharm, PhD, J. Rick Turner PhD, DSc, FAHA, FACC, FESC, FCP
Pages: 284-294 | First Published: 19 November 2019

Review
Mycophenolic Acid and Its Pharmacokinetic Drug‐Drug Interactions in Humans: Review of the Evidence and Clinical Implications
Juthipong Benjanuwattra MD, Dumnoensun Pruksakorn MD, PhD, Nut Koonrungsesomboon MD, PhD
Pages: 295-311 | First Published: 08 December 2019

Drug Interactions
Pharmacokinetic Drug‐Drug Interactions Between Trospium Chloride and Ranitidine Substrates of Organic Cation Transporters in Healthy Human Subjects
Bayew Tsega Abebe MSc, Michael Weiss PhD, Christiane Modess MD, Tobias Tadken MD, Danilo Wegner, Marleen J. Meyer, Ulrich Schwantes PhD, Claudia Neumeister PhD, Eberhard Scheuch PhD, Hans‐Ulrich Schulz PhD, Mladen Tzvetkov PhD, Werner Siegmund MD
Pages: 312-323 | First Published: 22 September 2019

Effect of Levetiracetam on Time to High‐Dose Methotrexate Clearance in Patients With Hematologic Malignancies
Uvette Lou PharmD, Jamie Kwok PharmD, Thu Anne Nguyen PharmD, Allen Zhou PharmD, Samantha O. Luk PharmD
Pages: 324-330 | First Published: 14 November 2019

Pharmacometrics
Population Pharmacokinetics of Glecaprevir/Pibrentasvir in HCV‐infected Japanese Subjects in Phase 3 CERTAIN‐1 and CERTAIN‐2 Trials
Ahmed Abbas Suleiman PhD, Chih‐Wei Lin PhD, Wei Liu PhD, Doerthe Eckert MSc, Sven Mensing PhD, Margaret Burroughs MD, Koji Kato MD, Kazuaki Chayama, Hiromitsu Kumada, Rajneet K. Oberoi PhD
Pages: 331-339 | First Published: 12 September 2019

A Population Pharmacokinetic Model of Oral Docetaxel Coadministered With Ritonavir to Support Early Clinical Development
Huixin Yu PhD, Julie M. Janssen PharmD, Emilia Sawicki PhD, J. G. Coen van Hasselt PhD, Vincent A. de Weger MD, PhD, Bastiaan Nuijen PharmD, PhD, Jan H. M. Schellens MD, PhD, Jos H. Beijnen PharmD, PhD, Alwin D. R. Huitema PharmD, PhD
Pages: 340-350 | First Published: 09 October 2019

Pharmacogenomics
CYP2B6*6 Genotype Specific Differences in Artemether‐Lumefantrine Disposition in Healthy Volunteers
Sa'ad T. Abdullahi PhD, Julius O. Soyinka PhD, Adeniyi Olagunju PhD, Rahman A. Bolarinwa MBChB, Olusola J. Olarewaju MBChB, Moji T. Bakare‐Odunola PhD, Markus Winterberg PhD, Joel Tarning PhD, Andrew Owen PhD, Saye Khoo PhD
Pages: 351-360 | First Published: 23 September 2019

Association of ABCC Gene Polymorphism With Susceptibility to Antituberculosis Drug–Induced Hepatotoxicity in Western Han Patients With Tuberculosis
Hao Bai MD, Tao Wu PhD, Lin Jiao PhD, Qian Wu MD, Zhenzhen Zhao MD, Jiajia Song MD, Tangyuheng Liu MD, Yanghua Lv MD, Xiaojun Lu MD, Binwu Ying PhD
Pages: 361-368 | First Published: 24 October 2019

Drug Development
The Case for an Unblinded Modeler in Early Clinical Development
Andreas Krause PhD, Andrea Henrich PhD, Jasper Dingemanse PharmD, PhD, FCP
Pages: 369-377 | First Published: 25 September 2019

Continuing Education: Therapeutics
Evaluation of Occipital Nerve Blocks for Acute Pain Relief of Migraines
Alex M. Ebied PharmD, BCCCP, Duong T. Nguyen BA, Tanaka Dang BS
Pages: 378-383 | First Published: 08 October 2019

Therapeutics
More Frequent Premature Antibiotic Discontinuations and Acute Kidney Injury in the Outpatient Setting With Vancomycin Compared to Daptomycin
Daniel Tuerff BS, MS, Marina Nunez MD, PhD
Pages: 384-390 | First Published: 20 October 2019

Pharmacokinetics
Effect of Plasma Protein Binding on the Pharmacokinetics of Erdafitinib: Results of an Integrated Cross‐Study Analysis
Lilian Y. Li PhD, Yue Guo PhD, Martha Gonzalez BS, Daniele Ouellet PhD
Pages: 391-399 | First Published: 10 October 2019

Editor's Choice: Therapeutics
Effects of the Fluoroquinolones Moxifloxacin and Levofloxacin on the QT Subintervals: Sex Differences in Ventricular Repolarization
Jӧrg Täubel MD, FFPM, Krishna Prasad MD, FRCP, Giuseppe Rosano MD, PhD, FESC, FHFA, Georg Ferber PhD, Helen Wibberley MBBS, Samuel Thomas Cole BM, BS, Leen Van Langenhoven PhD, Sara Fernandes PhD, Dilshat Djumanov PhD, Atsushi Sugiyama MD, PhD
Pages: 400-408 | First Published: 21 October 2019

Adverse Drug Reactions
Role of Oxidative Stress in Hypersensitivity Reactions to Sulfonamides
Abdelbaset A. Elzagallaai PhD, Elham A. Sultan MSc, John R. Bend PhD, Awatif M. Abuzgaia MD, Eman Loubani MD, Michael J. Rieder MD, PhD
Pages: 409-421 | First Published: 10 November 2019
http://bit.ly/2Ijxci7 #ACCPJCP

02/28/2020

Keep your eye on the prize! A new job could be right under your nose on the #ACCPJOBCTR. Take a peek at the new job postings today! http://bit.ly/2J0TTKj
#pharmacology #jobsearch

02/28/2020

ACCP "Excellence in Achievement" - Joanna C. Masters, PharmD

ACCP is pleased to recognize Joanna C. Masters, PharmD, Associate Director of Clinical Pharmacology & Pharmacometrics in Global Product Development at Pfizer Inc in San Diego, CA. Dr. Masters completed a postdoctoral fellowship in clinical pharmacology and oncology, through a joint Pfizer-Univ of California San Diego fellowship program in 2013. She then joined Pfizer as a clinical pharmacology lead in early development, working primarily on first-in-patient studies for antibody drug conjugates and thereafter moved into oncology clinical pharmacology working in both early and late-stage development on small molecules and biologics. Dr. Masters supports multiple oncology programs at various stages of development through both traditional clinical pharmacology and quantitative pharmacology approaches, including modeling and simulation work in PopPK and PK/PD supporting study design and regulatory submissions. She has worked as a clinical pharmacology lead on multiple programs across various assets and indications and has contributed to five different global submissions all reaching regulatory approval. In addition, Dr. Masters serves as a pharmacometrics lead partnering with clinical pharmacology leads, statisticians and clinicians to ensure a robust quantitative drug development plan is in place to support clinical development of an asset. She is interested in the pursuit of increased integration of the clinical perspective with quantitative clinical pharmacology in order to make timely and impactful development strategy decisions across all stages of clinical development for new therapies.

Dr. Masters is a voluntary faculty member at Univ of California San Diego School of Pharmacy and teaches and precepts pharmacy students and fellows in clinical pharmacology education and research projects throughout the year; she is especially proud to see multiple trainees go on to pursue post-graduate fellowships in clinical pharmacology. Her teaching also includes lecturing on the importance of clinical pharmacology concepts to students pursuing a Masters degree in drug development. She has published many peer-reviewed journal articles and abstracts on various topics in general clinical pharmacology, quantitative clinical pharmacology and oncology. Dr. Masters is an active member of ACCP, serving on the Public Policy Committee since 2017, through which she has published a key policy statement on eligibility criteria in oncology trials and chaired a symposium on the topic at the 2019 ACCP Annual Meeting.

Dr. Masters earned her Bachelor of Arts in chemistry and biochemistry at the Univ of San Diego as a Goldwater Scholar and Phi Beta Kappa member and then went on to earn her Doctor of Pharmacy degree from UC San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences, where she continues to teach.

Dr. Masters shared her thoughts on what ACCP membership means to her: “Opportunity is the first word that comes to mind when I reflect on what ACCP membership means to me. ACCP allows all Members to be involved in various ways, to create impact with contributions and to network with clinical pharmacology experts from broad backgrounds. In particular, I appreciate that ACCP encourages and facilitates active engagement in the first 1 – 10 years of one’s career. There is opportunity regardless of your professional level, as long as you have the passion and commitment to jump in and collaborate with other Members. I have had the great privilege to meet and work alongside stellar professionals across industry, academia, regulatory and clinical practice, through active participation in the Public Policy Committee and during symposium planning. My first experience at ACCP was as a post-doctoral fellow and the intimate, cross-functional, learning-focused environment in which participants were approachable made a distinct impression on me. When I decided to pursue involvement in the clinical pharmacology community in the first few years entering my career post-fellowship, ACCP was the obvious choice.”

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

#ACCPExcellenceAchievement #pharmacology

02/28/2020

*ACCP & ISoP Sign a Collaborative Memorandum of Understanding*

The American College of Clinical Pharmacology® (ACCP) and the International Society of Pharmacometrics (ISoP) are pleased to announce the execution of a revised collaborative Memorandum of Understanding.

"ACCP and ISoP will work together to achieve the Mission & Vision of both societies to develop educational and other content that benefits the global clinical pharmacology community", said Vikram Arya, PhD, FCP, President of ACCP.

“ISoP and ACCP are excited to continue this relationship, leveraging the vision of both societies to create increased benefits for both the Pharmacometrics and Clinical Pharmacology communities”, said Brenda Cirincione PhD, President of ISoP.

Existing collaborations include:

• ACCP/ISoP SIG Student Abstract Award presented at the ACCP Annual Meeting. The SIG identifies areas of submission that are consistent with its focus and Student & Trainee abstracts within those areas are reviewed and scored by SIG Leadership. The top scoring Student abstract is the recipient of the ACCP/ISoP Student Abstract Award, which includes complimentary 3-Day registration to the ACCP Annual Meeting, a $500 honorarium, an award and an invitation to the Regents & Awards Dinner.

• An ACCP/ISoP jointly-sponsored Symposium titled "Assessing the Feasibility of Model-informed Precision Dosing: A Point-Counterpoint Debate" will be held September 21st at the 2020 ACCP Annual Meeting in Bethesda, MD. ACCP will provide CME & CPE credits for the course.

• The ACCP/ISoP SIG breakfast at the 2020 ACCP Annual Meeting.

• Meet the ACCP/ISoP Clinical Pharmacometrics SIG Luncheon at ACoP each year.

• ACoP Clinical Pharmacometrics Abstract Award (for Trainees only).

ACCP and ISoP look forward to the continued opportunities from this collaboration. The Clinical Pharmacometrics Special Interest Group (SIG) is an example of this collaboration.

02/27/2020

www.sacaccp.org

ACCP is pleased to announce the *13th Annual Conference on Clinical Pharmacology: Expanding Horizons* for the South Asian College of Clinical Pharmacology, an Affiliate of ACCP!

Dates: April 28 – May 1, 2020
Location: Mumbai Cricket Association Recreation Centre, Mumbai, India

For more info please visit...http://bit.ly/32vgfuS

02/26/2020

🔹 Only Two Weeks 🔹 until the March #ACCPVJC Webinar: Real‐World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol Extended‐Release Case Study

Date: Wednesday, March 11, 2020 @ 2:00 PM ET
Faculty: Joshua Brown, PharmD, PhD, Assistant Professor, Dept of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy
Register today! http://bit.ly/ACCPVJC

02/24/2020

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing

MedWatch Safety Alert: Phenytoin Oral Suspension USP, 125 mg/5 mL by Taro Pharmaceuticals: Recall - Due to Possible Underdosing or Overdosing

Taro Pharmaceuticals is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL in 237 mL bottles. The reason for the recall is that product may not re-suspend when shaken which could result in under or overdosing.

Read Recall: http://bit.ly/3c4ix8F

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal)...

02/20/2020

The American College of Clinical Pharmacology® is pleased to announce the new Quarterly Update! The Quarterly Update replaces the Annual Report and will provide information about goals achieved in the previous quarter. Please take a moment to read the Q4 2019 Quarterly Update! https://conta.cc/2tSVNHw

02/20/2020

❓ Have You Submitted Your Abstract ❓ | #2020ACCP Annual Meeting

April 15th is the deadline to Submit an Abstract for the #2020ACCP Annual Meeting, Sept 20 - 22 at the Bethesda N Marriott Hotel & Conf Ctr, Bethesda, MD.

Accepted abstracts will be published online in Clinical Pharmacology in Drug Development journal.

Learn more...http://bit.ly/2FSYYBk
#pharmacology #conference

02/19/2020

⭐ Reminder ⭐ Register for the March #ACCPVJC Webinar: Real‐World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol Extended‐Release Case Study

Date: Wednesday, March 11, 2020
Time: 2:00 - 3:00 PM ET
Faculty: Joshua Brown, PharmD, PhD, Assistant Professor, Dept of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy
Register: http://bit.ly/ACCPVJC

After completing this activity, the learner will be able to:
1) Develop a framework to use real-world healthcare data to detect and verify signals related to generic drugs;
2) Implement this framework in active surveillance to generate hypotheses or be used to confirm observations from other evidences.