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 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.

American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing exceptional interdisciplinary, accredited Continuing Education programs, publications, networking and other career-enhancing opportunities to a wide spectrum of health care professionals using clinical pharmacology in disciplines from research to patient care.

Mission: Vision & Mission To improve health by optimizing therapeutics. Provide innovative leadership and interdisciplinary education that will enable the generation, integration and translation of scientific knowledge to optimize research, development and utilization of medication for the benefit of all.

Accelerating Drug Development for Polyarticular Juvenile Idiopathic Ar

*FDA Announces a Public Workshop Entitled “Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)” for October 2, 2019*

The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a one-day public workshop entitled “Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)” on October 2, 2019.

The objectives of this workshop are to:

1. Discuss the current barriers to expeditious pJIA drug development and steps to overcome them.
2. Discuss specific topics related to extrapolation, trial design considerations, dose selection, modeling and simulation, and level of evidence required to establish safety and effectiveness in pediatric patients with pJIA.

Clinicians, investigators, clinical pharmacologists, patients and parents of patients, device manufacturers, pharmaceutical companies, contract research organizations, non-profit organizations focused on arthritis, regulators, etc. are encouraged to attend.

Date: October 2, 2019
Time: 8:00 am – 5:00 pm
Location: FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Silver Spring, MD 20993

Additional information about this workshop, including registration, webcast instructions, and parking and directions, is available at http://bit.ly/32iqIcp.

Registration to attend in-person or view the webinar is free. Individuals who wish to view the webcast are still required to complete registration for the conference.

If you have any additional questions about this workshop, please contact [email protected].

fda.gov Public workshop

Clinical Pharmacology in Drug Development, July 2019 Volume 8, Issue 5 is now available!

*Articles*
A Randomized, Placebo‐Controlled, Multiple‐Ascending‐Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Soluble Guanylate Cyclase Stimulator Praliciguat in Healthy Subjects
John P. Hanrahan, James D. Wakefield, Phebe J. Wilson, Marina Mihova, Jennifer G. Chickering, Dennis Ruff, Michael Hall, G. Todd Milne, Mark G. Currie, Albert T. Profy
Pages: 564-575 | First Published: 13 November 2018

Pharmacokinetics of a Lobeglitazone/Metformin Fixed‐Dose Combination Tablet (CKD‐395 0.5/1000 mg) Versus Concomitant Administration of Single Agents and the Effect of Food on the Metabolism of CKD‐395 in Healthy Male Subjects
Sun‐Young Kim, Ji‐Young Jeon, Shin Jung Park, Min‐Gul Kim
Pages: 576-584 | First Published: 17 October 2018

The Relative Bioavailability and Effects of Food and Acid‐Reducing Agents on Filgotinib Tablets in Healthy Subjects
Kacey Anderson, Hao Zheng, Mona Kotecha, Jennifer Cuvin, Bob Scott, Shringi Sharma, Ann Ran‐Ran Qin, Florence Namour, Yan Xin
Pages: 585-594 | First Published: 15 February 2019

An Open‐Label, Single‐Dose, Human Mass Balance Study of Amenamevir in Healthy Male Adults
Kota Kato, Martin den Adel, Dorien Groenendaal‐van de Meent, Yoshiaki Ohtsu, Akitsugu Takada, Masataka Katashima
Pages: 595-602 | First Published: 09 November 2018

A Phase 1 Assessment of the QT Interval in Healthy Adults Following Exposure to Rolapitant, a Cancer Supportive Care Antiemetic
Xiaodong Wang, Zhi‐Yi Zhang, Jing Wang, Vikram Kansra
Pages: 603-611 | First Published: 26 September 2018

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Dose of Miridesap in Healthy Japanese Subjects
Hiroko Ino, Yohei Doi, Lia Liefaard, Louise Cookson, Chao Chen, Hiroshi Itoh, Harue Igarashi, Atsushi Nakano
Pages: 612-618 | First Published: 17 December 2018

Effect of Food on the Pharmacokinetics of Ertugliflozin and Its Fixed‐Dose Combinations Ertugliflozin/Sitagliptin and Ertugliflozin/Metformin
Vaishali Sahasrabudhe, Daryl J. Fediuk, Kyle Matschke, Haihong Shi, Yali Liang, Anne Hickman, Almasa Bass, Steven G. Terra, Susan Zhou, Rajesh Krishna, Vikas K. Dawra
Pages: 619-627 | First Published: 14 November 2018

Pharmacokinetics and Safety of CSL112 (Apolipoprotein A‐I [Human]) in Adults With Moderate Renal Impairment and Normal Renal Function
Michael A. Tortorici, Danielle Duffy, Rebecca Evans, John Feaster, Andreas Gille, Timothy G. K. Mant, Samuel D. Wright, Denise D'Andrea
Pages: 628-636 | First Published: 21 September 2018

Characterizing the Sources of Pharmacokinetic Variability for TAK‐117 (Serabelisib), an Investigational Phosphoinositide 3‐Kinase Alpha Inhibitor: A Clinical Biopharmaceutics Study to Inform Development Strategy
Chirag G. Patel, Lakshmi Rangachari, Mark Patti, Celina Griffin, Yaping Shou, Karthik Venkatakrishnan
Pages: 637-646 | First Published: 31 August 2018

Effects of Food and Antacids on Pharmacokinetics and Pharmacodynamics of Lesinurad, a Selective Urate Reabsorption Inhibitor
Zancong Shen, Caroline A. Lee, Shakti Valdez, Xiaojuan Yang, David M. Wilson, Talia Flanagan, Michael Gillen
Pages: 647-656 | First Published: 12 February 2019

Lesinurad: Evaluation of Pharmacokinetic and Pharmacodynamic Interactions With Warfarin in Healthy Volunteers
Zancong Shen, Caroline A. Lee, Kathleen Wallach, Shakti Valdez, David M. Wilson, Bradley Kerr, Michael Gillen
Pages: 657-663 | First Published: 13 February 2019

A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Patients With Hepatic Impairment and Healthy Matched Controls
Jafar Sadik B. Shaik, Susan L. Ford, Yu Lou, Zhiping Zhang, Kalpana K. Bakshi, Allan R. Tenorio, Christine Trezza, William R. Spreen, Parul Patel
Pages: 664-673 | First Published: 27 February 2019

A Phase I Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Adults With Severe Renal Impairment and Healthy Matched Control Participants
Ridhi Parasrampuria, Susan L. Ford, Yu Lou, Caifeng Fu, Kalpana K. Bakshi, Allan R. Tenorio, Christine Trezza, William R. Spreen, Parul Patel
Pages: 674-681 | First Published: 27 February 2019

Population Pharmacokinetic Modeling and Probability of Target Attainment Analyses in Asian Patients With Community‐Acquired Pneumonia Treated With Ceftaroline Fosamil
Jianguo Li, Shampa Das, Diansong Zhou, Nidal Al‐Huniti
Pages: 682-694 | First Published: 01 May 2019

*Erratum*
Erratum
Pages: 695 | First Published: 14 May 2019

#ACCPCPPD http://bit.ly/2Q6BbCm

The Journal of Clinical Pharmacology - July 2019, Vol 59, Issue 7 is now available!

*List of Reviewers*
2018 reviewer thank you list
Pages: 907-908 | First Published: 04 June 2019

*ACCP Policy Statement*
The Potential Role of the J‐Tpeak Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium
Jose Vicente PhD, David G. Strauss MD, PhD, Vijay V. Upreti PhD, FCP, Michael J. Fossler PharmD, PhD, FCP, Philip T. Sager MD, Robert Noveck MD, PhD, FCP
Pages: 909-914 | First Published: 25 March 2019

*Core Entrustables in Clinical Pharmacology: Pearls for Practice*
Core Entrustable Professional Activities in Clinical Pharmacology for Entering Residency: Common Problem Drugs and How to Prescribe Them
Vera S. Donnenberg PhD, FCP, Philip Chaikin PharmD, MD, FCP, Maja Mandic MD, Bernd Meibohm PhD, FCP, FAAPS, John van den Anker MD, FCP, Erin Rhinehart MD, Anne N. Nafziger MD, PhD, MHS, FCP, James F. Burris MD, FCP, The American College of Clinical Pharmacology
Pages: 915-922 | First Published: 15 February 2019

*Editor's Choice: Review*
A Review of Human Studies Assessing Cannabidiol's (CBD) Therapeutic Actions and Potential
C. Michael White PharmD
Pages: 923-934 | First Published: 07 February 2019

*Review*
Diarrhea With HER2‐Targeted Agents in Cancer Patients: A Systematic Review and Meta‐Analysis
Jing Li MS
Pages: 935-946 | First Published: 01 February 2019

*Pharmacokinetics*
Enhanced Intranasal Absorption of Naltrexone by Dodecyl Maltopyranoside: Implications for the Treatment of Opioid Overdose
Philip Krieter PhD, Shwe Gyaw MD, C. Nora Chiang PhD, Roger Crystal MD, Phil Skolnick PhD, DSc (Hon)
Pages: 947-957 | First Published: 30 January 2019

Metabolism, Excretion, and Pharmacokinetics of [14C]‐Cefiderocol (S‐649266), a Siderophore Cephalosporin, in Healthy Subjects Following Intravenous Administration
Shiro Miyazaki MS, Takayuki Katsube PhD, Helen Shen PhD, Charles Tomek MD, Yukitoshi Narukawa PhD
Pages: 958-967 | First Published: 07 February 2019

*Pharmacokinetics/Pharmacodynamics*
Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability of JNJ‐61178104, a Novel Tumor Necrosis Factor‐Alpha and Interleukin‐17A Bispecific Antibody, in Healthy Subjects
Derrick E. Akpalu PhD, Bart Frederick BS, Ivo P. Nnane PhD, Zhenling Yao PhD, Fang Shen PhD, Tatiana Ort PhD, Damien Fink MS, Shannon Dogmanits BS, Donald Raible MD, Amarnath Sharma PhD, Zhenhua Xu PhD, FCP
Pages: 968-978 | First Published: 18 February 2019

*Pharmacometrics*
Population Pharmacokinetics of Vamorolone (VBP15) in Healthy Men and Boys With Duchenne Muscular Dystrophy
Panteleimon D. Mavroudis PhD, John van den Anker MD, PhD, Laurie S. Conklin MD, Jesse M. Damsker MD, Eric P. Hoffman PhD, Kanneboyina Nagaraju PhD, Paula R. Clemens MD, William J. Jusko PhD
Pages: 979-988 | First Published: 11 February 2019

*Pediatric Pharmacology*
Utilization of Adult Data in Designing Pediatric Pharmacokinetic Studies: How Much Are Historical Adult Data Worth?
Chyi‐Hung Hsu PhD, Xu Steven Xu PhD, Jian Wang PhD, Liping Zhang PhD, Chao Liu PhD, Yaning Wang PhD
Pages: 989-996 | First Published: 12 February 2019

*Continuing Education: Pediatric Pharmacology*
The Effectiveness of a Vancomycin Dosing Guideline in the Neonatal Intensive Care Unit for Achieving Goal Therapeutic Trough Concentrations
Ashley M. Reilly PharmD, Michelle X. Ding PharmD, Joseph E. Rower PhD, Tyree H. Kiser PharmD
Pages: 997-1005 | First Published: 18 February 2019

*Pharmacogenetics*
Pharmacogenetic Profile and the Occurrence of Visual Hallucinations in Patients With Sporadic Parkinson's Disease
Erinaldo Ubirajara Damasceno dos Santos PhD, Elaine Bandeira Cavalcanti Duarte MSc, Laura Maria Ramos Miranda BSc, Amdore Guescel C. Asano PhD, Nadja Maria Jorge Asano PhD, Maria De Mascena Diniz Maia PhD, Paulo Roberto Eleutério de Souza PhD
Pages: 1006-1013 | First Published: 22 February 2019

The A/A Genotype of XPO1 rs4430924 Is Associated With Higher Risk of Antituberculosis Drug‐Induced Hepatotoxicity in Chinese Patients
Xiaomin He MSc, Haiping Zhang BSc, Bilin Tao MSc, Miaomiao Yang MSc, Hongbo Chen BSc, Lihuan Lu MSc, Honggang Yi PhD, Hongqiu Pan MSc, Shaowen Tang PhD
Pages: 1014-1021 | First Published: 28 February 2019

*Drug Interactions*
Absence of Drug‐Drug Interaction of Anastrozole on Levonorgestrel Delivered Simultaneously by an Intravaginal Ring: Results of a Phase 2 Trial
Rüdiger Nave PhD, Uwe Mellinger Dipl‐Math, Stefan Klein PhD, Joachim Höchel PhD, Heinz Schmitz MD
Pages: 1022-1028 | First Published: 21 February 2019

http://bit.ly/2Ijxci7 #ACCPJCP

Looking for a change? New jobs are posted daily on the #ACCPJOBCTR. Be sure to visit today...http://bit.ly/31S06yP

Sunday, June 30th is the deadline to take advantage of the Early Bird discounted registration rate for the #2019ACCP Annual Meeting! Don't delay and register today...http://bit.ly/2Jnn3QT

We look forward to seeing you in September!

July 31st is the deadline to submit a Proposal for the #2020ACCP Annual Meeting, "Translating Clinical Pharmacology Research into Patient-centered Care", Sept 20 - 22, 2020 in Bethesda, MD!

We look forward to receiving your Proposals!

http://bit.ly/2020Proposals

[Today @ 2PM ET] #ACCPVJC Webinar | Toward Better Understanding of Insulin Therapy by Translation of a PK-PD Model to Visualize Insulin and Glucose Action Profiles

We hope you can join us! Register: http://bit.ly/ACCPVJC

[Tomorrow: June 26th @ 2 PM ET] #ACCPVJC Webinar | Toward Better Understanding of Insulin Therapy by Translation of a PK-PD Model to Visualize Insulin and Glucose Action Profiles

Reigster today....http://bit.ly/ACCPVJC

Don't Forget...July 1st is the deadline to submit your personal testing report for use in the *Interprofessional Education in Pharmacogenomics, an ACCP/AACP Jointly-sponsored Pre-meeting Workshop* at the #2019ACCP Annual Meeting.

Please note that you can still register for the Workshop after this date and use general data made available for the Workshop!

Register today! http://bit.ly/2Jnn3QT

If you haven't already done so be sure to register by June 30th to take advantage of the Early Bird discounted registration rate for the #2019ACCP Annual Meeting!

You don't want to miss celebrating ACCP's 50th Anniversary! A few meeting highlights include:

- ACCP's 50th Anniversary Gala | Saturday, Sept 14th
- A Unique Hands-on Pre-meeting Workshop on Pharmacogenomics | Saturday, Sept 14th
- ACCP Honor Wall

Register today...http://bit.ly/2Jnn3QT

⭐ ACCP Welcomes New Director of Education - Haydee Barno, MBA, CMP-HC

ACCP is pleased to welcome Mrs. Haydee Barno as the Director of Education at the American College of Clinical Pharmacology® (ACCP). Prior to joining ACCP, Haydee was employed as the Director of Continuing Medical Education at the American Society of Cataract and Refractive Surgery (ASCRS), a notational professional medical specialty dedicated to empowering Anterior Segment Surgeons to improve the vision, outcomes and quality of life for their patients through innovative approaches to Education, Advocacy and Philanthropy. During her tenure at ASCRS, Haydee was responsible for directing the Society’s Continuing Medical Education (CME) program. In this position, she was responsible for overseeing and advising the Clinical Education department and other programming staff on the latest ACCME policies, criteria and standards and for making recommendations for program improvements. Prior to joining ASCRS, Haydee was employed as the Director of Education at Destinations International (DI), a national trade association empowering destination marketing and management professionals to drive destination economic impact, job creation, community sustainability and quality of life through travel. In that role, Mrs. Barno was responsible for directing and managing the Certified Destination Management Executive (CDME) certification program and the Professional in Destination Management (PDM) certificate program in partnership with George Washington University. She also directed initiatives to curate and design cutting edge educational opportunities for the annual convention, summit meetings and online opportunities.

Prior to joining Destinations International, Haydee was employed as the Director, Continuing Education at the American College of Preventive Medicine (ACPM), a national professional medical specialty society dedicated to Disease Prevention and Health Promotion. During her tenure at ACPM, Haydee was responsible for directing the planning and execution of the organization's continuing Medical Education (CME) and Maintenance of Certification (MOC) programs. In her position, she worked with the Conference Planning and Continuing Medical Education committees to design, develop, and implement high quality programs and educational products.

Mrs. Barno earned her law degree from the Universidad Americana of Managua (UAM) prior to moving to United States in December of 2000 and earned her MBA in 2008 at Strayer University in Washington, DC. She is also a Certified Meeting Professional in Health Care (CMP-HC). Mrs. Barno is fluent in English and Spanish.

Ms. Barno lives in Chantilly, VA with her husband Christofer Barno and her two children, Cristiana and Christofer Barno.

Please welcome us in joining Haydee to ACCP!

Historical Retrospective Series: How ACCP provides the right benefits to enhance your career!

Membership in ACCP offers the support and professional development at every level of your career. For the past 50 years, ACCP has been and will continue to be a welcoming and inclusive organization focused on its Members, offering a vibrant professional community where you can build professional relationships that last a lifetime.

As a Member-focused/Member-driven organization, ACCP consistently strives to exceed the expectations of its Members by providing ways to stay on top of your professional game, help you build professional relationships that last a lifetime and provide you with a vibrant professional community with similar goals and objectives that gives you opportunities to shape the future of clinical pharmacology.

Read more about ACCP Benefits here: http://bit.ly/2Y6QoGG

pharmacy.umaryland.edu

Topical Drug Development -- Evolution of Science and Regulatory Policy

*FDA and University of Maryland Announce Workshop Entitled “Topical Drug Development - Evolution of Science and Regulatory Policy” for July 29-30, 2019*

The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day public workshop entitled “Topical Drug Development - Evolution of Science and Regulatory Policy” on July 29-30, 2019. This workshop will bring together stakeholders from the FDA, academia, and industry to discuss the underpinnings of the Maximal Usage Study (MUsT) program, the successful incorporation of MUsT in drug development, and the utilization of in vitro methods in product development.

The assessment of dermal absorption in topical drug development is a relative new-comer to clinical pharmacology and pharmacokinetics, in general. This has historically been due to the lack of both sufficient analytical models and standardized assessment protocols. In the early 1990s, the FDA initiated the development of a MUsT paradigm designed to both assist in the evaluation of in vivo safety by providing direct assessment of plasma levels following application of topical products, and to provide information on the effects of disease and formulation on dermal penetration. Since its introduction, the MUsT paradigm has been used in the development program of every topically applied New Drug Application (NDA) in the U.S. The increased scrutiny of topical antiseptics and sunscreens has led to the adoption of the MUsT paradigm into the area on non-prescription drug products via both draft and final rules for antiseptics, a safety and effectiveness guidance for sunscreens, the draft and pending final rule for sunscreens, and the recently published final guidance for industry entitled "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” In parallel, in vitro permeation methods have progressed to the point where they can be used, in conjunction with the in vivo MUsT paradigm, as a tool in the successful development of topical drugs.

The objectives of this workshop are to:

1. To present the background of the current regulatory policy in the area of dermal absorption and its underpinnings.
2. To provide examples of the successful incorporation of both in vivo (MUsT) and in vitro (percutaneous permeation studies, i.e., IVPT) in drug development.
3. To facilitate discussion as to the design elements and concerns of both in vivo and in vitro methods in the new drug and over-the-counter (OTC) drug space.
4. To stimulate discussion between interested parties in the evolution of science in the area of topical drug development and dermal absorption testing.

Additionally, data from the recent FDA publication of their pilot sunscreen MUsT program will be discussed along with how this information can be used to augment and improve the development of non-prescription drugs, both under the rubric of an NDA and the OTC Monograph system.

The date, time, location, and other details of the workshop are as follows:

Date: July 29-30, 2019
Time: 8:30 am – 5:00 pm
Location: University of Maryland School of Pharmacy, 20 N. Pine Street, Baltimore, MD 21201

Additional information about this workshop, including registration, agenda, poster submission instructions, and parking and directions, is available at http://bit.ly/2Y4QZsa.

Registration can be accessed at http://bit.ly/2Y7WmqS. In addition to the live program, the workshop will be broadcasted via a livestream webinar on July 29-30, 2019. Individuals who cannot attend the event in-person but wish to view the webinar are still required to complete registration for the conference. Registration to view the webinar is free.

If you have any additional questions about this workshop, please contact [email protected].

pharmacy.umaryland.edu Mark your calendars for "Topical Drug Development -- Evolution of Science and Regulatory Policy," a two-day workshop sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Want your school to be the top-listed School/college in Ashburn?

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Location

Telephone

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21750 Red Rum Dr, Ste 137
Ashburn, VA
20147

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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