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.

Registration Reminder...ACCP Webinar: Communicating Your Science: From Blank Screen to Published Article for Students, Trainees & Early-stage Professionals

Date/Time: Feb 3rd @ 11:00 AM - 12:30 PM ET
CE Credits: 1.5 CME/1.5 CPE credits

Why is this webinar important to you?
Disseminating the results of scientific research as manuscripts and getting published is the ultimate accumulation of research and goal of all scientists. ACCP wants to advance the cumulative knowledge of all working in the field. Attendees will be guided through the steps of drafting an outline, completing a manuscript and understanding the key elements of the review process for publication. The webinar provides the opportunity to acquire knowledge on writing, organizing and revising of manuscripts.

Register Today! http://bit.ly/2FlzL2e
#pharmacology #CE

Call for Abstracts | 2020 ACCP Annual Meeting

ACCP invites you to Submit an Abstract for the 2020 ACCP Annual Meeting, Sept 20 - 22, 2020 at the Bethesda N Marriott Hotel & Conf Ctr, Bethesda, MD.

• Network with leaders in the field of clinical pharmacology representing academia, industry, regulatory agencies and clinical practice;
• Interact with a global audience of healthcare professionals;
• Be part of an educational event that includes outstanding Workshops and Symposia on current, relevant topics related to the optimal development and use of therapeutics;
• Student Abstract Awards Program provides a $1,000 honorarium for each of the top eight Student Abstracts and travel support of up to $500 each for the top 16 Student Abstracts;
• NEW in 2020, a Student/Trainee Travel Grant for ACCP Student Members sponsored by Nuventra Pharma Sciences

The Abstract Submission Deadline is April 15th.
http://bit.ly/2FSYYBk
#pharmacology

⏰ One Week Until the January #ACCPVJC Webinar: Characterization of Severe Adverse Drug Reactions at a Free-Standing Children’s Hospital

Wednesday, January 22nd @ 2:00 PM ET
Faculty: Jennifer Goldman, MD, Associate Professor, Pediatrics, Infectious Diseases and Clinical Pharmacology, Children's Mercy Kansas City and Sarah Suppes, PharmD, Clinical Pharmacy Specialist, Div of Clinical Pharmacology, Toxicology & Therapeutic Innovation, Children's Mercy Kansas City

Register Today! http://bit.ly/ACCPVJC
#pharmacology #CE

fda.gov

Belviq, Belviq XR (lorcaserin): Drug Safety Communication

FDA MedWatch: Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer

ISSUE: The FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review.

BACKGROUND: Lorcaserin is a prescription medicine approved by FDA in 2012 for use with a reduced-calorie diet and increased physical activity to help weight loss in adults who are obese or are overweight and have weight-related medical problems. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet (Belviq) and an extended-release tablet (Belviq XR).

RECOMMENDATION: Health care professionals should consider if the benefits of taking lorcaserin are likely to exceed the potential risks when deciding whether to prescribe or continue patients on lorcaserin.

Patients currently taking lorcaserin should talk to their health care professionals about the potential increased risk of cancer with use of lorcaserin.
http://bit.ly/35SUV2A

fda.gov FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).

📣 The American College of Clinical Pharmacology® (ACCP) is pleased to present its newly redesigned homepage!

The redesign was created with Members in mind to easily keep the global clinical pharmacology community updated on what is happening at ACCP.

The homepage prominently displays
• news, upcoming webinars and events;
• Early-stage Professionals program developments;
• new Member Spotlight recognizing ACCP Members for contributions to ACCP and the field of clinical pharmacology;
• continued easy access to ACCP journals and the Job Center.

Check out the new ACCP1.org now!

Don't Forget...ACCP Webinar: Communicating Your Science: From Blank Screen to Published Article for Students, Trainees & Early-stage Professionals

Date/Time: Feb 3rd @ 11:00 AM - 12:30 PM ET
CE Credits: 1.5 CME/1.5 CPE credits

Goal & Objectives
After completing this activity, the learner will be able to:
- Articulate the process and key steps of outlining, drafting, editing and submitting a manuscript to communicate research to the scientific community or within a current career in clinical pharmacology;
- Demonstrate newly-gained knowledge of the process of writing, reviewing, editing and revising draft scientific manuscripts in order to improve the likelihood of acceptance and provide a high-quality revised manuscript;
- Recognize different manuscript formats (brief reports, short communication, expert opinion, full-length article and review article) and appropriate supporting documents/supplemental material that are necessary to effectively communicate scientific research results;
- Deepen the expertise and understanding of the differences between journals and to choose the appropriate journal in order for research to achieve the best exposure/impact;
- Recognize potential of target journal being a predatory or opportunistic journal.

Register: http://bit.ly/2FlzL2e
#pharmacology #CE

Two Weeks Until the January #ACCPVJC Webinar: Characterization of Severe Adverse Drug Reactions at a Free-Standing Children’s Hospital

Date: Wednesday, January 22, 2020
Time: 2:00 - 3:00 PM (ET)
Faculty: Jennifer Goldman, MD, Associate Professor, Pediatrics, Infectious Diseases and Clinical Pharmacology, Children's Mercy Kansas City and Sarah Suppes, PharmD, Clinical Pharmacy Specialist, Div of Clinical Pharmacology, Toxicology & Therapeutic Innovation, Children's Mercy Kansas City
Register: http://bit.ly/ACCPVJC
#pharmacology #CE

The Journal of Clinical Pharmacology - January 2020, Vol 60, Issue 1 is now available!

Editor's Choice: Pediatric Pharmacology
A Retrospective Review of the Efficiency of First‐Dose Therapeutic Drug Monitoring of Gentamicin, Amikacin, and Vancomycin in the Pediatric Population
Wan Xuan Selina Lim BSc, Wen Bing Brandon Chua BSc, Jie Min Chua BSc, Qianyu Lee BSc, Jer Wei Chan BSc, Rehena Sultana MSc, Bao Hui Poh BSc
Pages: 7-15 | First Published: 25 August 2019

Continuing Education: Pediatric Pharmacology
Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants
Gregory B. Hammer MD, Lynne G. Maxwell MD, Brad M. Taicher DO, MBA, Mihaela Visoiu MD, David S. Cooper MD, MPH, Peter Szmuk MD, Leng Hong Pheng PhD, Nathalie H. Gosselin PhD, Jia Lu PhD, Krishna Devarakonda PhD, FCP
Pages: 16-27 | First Published: 25 August 2019

Therapeutics
Efficacy, Safety, and Tolerability of ONO‐4474, an Orally Available Pan‐Tropomyosin Receptor Kinase Inhibitor, in Japanese Patients With Moderate to Severe Osteoarthritis of the Knee: A Randomized, Placebo‐Controlled, Double‐Blind, Parallel‐Group Comparative Study
Naoki Ishiguro MD, PhD, Shusuke Oyama MEng, Ryunosuke Higashi MS, Kunio Yanagida MS
Pages: 28-36 | First Published: 08 July 2019


Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure‐Response Analyses in the Phase 3 APOLLO Trial in Patients With Hereditary Transthyretin‐Mediated (hATTR) Amyloidosis
Xiaoping Zhang MD, PhD, Varun Goel PhD, Husain Attarwala PhD, Marianne T. Sweetser MD, PhD, Valerie A. Clausen PhD, Gabriel J. Robbie PhD
Pages: 37-49 | First Published: 19 July 2019

Exposure‐Response Analysis for Mogamulizumab in Adults With Cutaneous T‐Cell Lymphoma
Mayumi Mukai MS, Diane Mould PhD, FCP, FAAPS, Hiroshi Maeda PhD, Kazuya Narushima MS, Douglas Greene PhD, FCP
Pages: 50-57 | First Published: 16 December 2019

Pharmacometrics
Population Pharmacokinetic Modeling of Mogamulizumab in Adults With Cutaneous T‐Cell Lymphoma or Adult T‐Cell Lymphoma
Mayumi Mukai MS, Hiroshi Maeda PhD, Kazuya Narushima MS, Diane R. Mould PhD, FCP, FAAPS, Douglas Greene PhD, FCP
Pages: 58-66 | First Published: 16 December 2019

Population Pharmacokinetic Model to Assess the Impact of Disease State on Thalidomide Pharmacokinetics
Allison Gaudy PhD, Renfang Hwang MS, Maria Palmisano MD, Nianhang Chen PhD
Pages: 67-74 | First Published: 07 August 2019

Special Populations
Effect of Lercanidipine on the Pharmacokinetics‐Pharmacodynamics of Carvedilol Enantiomers in Patients With Chronic Kidney Disease
Estela Hanauer Schaab PhD, Vera Lucia Lanchote PhD, Glauco Henrique Balthazar Nardotto PhD, Maria Paula Marques Pereira PhD, Márcio Dantas MD, PhD, Carlos Eduardo Paiva MD, Eduardo Barbosa Coelho MD, PhD
Pages: 75-85 | First Published: 28 July 2019

Drug Interactions
Effects of Upadacitinib Coadministration on the Pharmacokinetics of Sensitive Cytochrome P450 Probe Substrates: A Study With the Modified Cooperstown 5+1 Cocktail
Mohamed‐Eslam F. Mohamed PhD, Tian Feng PhD, Jeffrey V. Enejosa MD, Ogert Fisniku MSc, Ahmed A. Othman PhD, FCP
Pages: 86-95 | First Published: 05 August 2019

Effects of Maribavir on P‐Glycoprotein and CYP2D6 in Healthy Volunteers
Ivy H. Song PhD, Katarina Ilic MD, PhD, MPH, Joseph Murphy BS, Kenneth Lasseter MD, Patrick Martin MD
Pages: 96-106 | First Published: 06 August 2019

Assessment of Transporter Polymorphisms as a Factor in a BCRP Drug Interaction Study With Lanabecestat
Brian A. Willis PhD, Scott W. Andersen MS, Mosun Ayan‐Oshodi PhD, Douglas E. James BS, Emily Liffick MD, Kathleen Hillgren PhD, Yingying Guo PhD, Scott A. Monk PhD
Pages: 107-116 | First Published: 05 August 2019

Regulatory Science
Survey of Japanese Orphan Drug Program: Factors Related to Successful Marketing Approval
Kenji Harada MSc, Kazuki Toriyabe MSc, Shunsuke Ono PhD
Pages: 117-124 | First Published: 31 July 2019

Drug Development
Evaluation of the Effect of 5 QT‐Positive Drugs on the JTpeak Interval — An Analysis of ECGs From the IQ‐CSRC Study
Borje Darpo MD, PhD, Charles Benson MD, PhD, Randy Brown MSc, Corina Dota MD, Georg Ferber PhD, Jim Ferry PhD, Venkat Jarugula PhD, James Keirns PhD, Catherine Ortemann‐Renon PharmD, PhD, Thuan Pham, Steve Riley PharmD, PhD, Nenad Sarapa MD, MS, Mark Ticktin, Wojciech Zareba MD, PhD, Jean‐Philippe Couderc PhD
Pages: 125-139 | First Published: 05 August 2019

Letter to the Editor
Ceftriaxone Dosing in a Critically Ill Patient With Hypoalbuminemia During Continuous Venous Hemofiltration: Emphasis on Unbound Pharmacokinetics
Renée M. F. Ebisch MD, PhD, Sjoerd D. Meenks MSc, Norbert Foudraine MD, PhD, Paddy K. C. Janssen PhD, Jos L. M. L. le Noble MD, PhD
Pages: 140-142 | First Published: 13 August 2019

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

ACCP Webinar: Communicating Your Science: From Blank Screen to Published Article for Students, Trainees & Early-stage Professionals

Date/Time: Feb 3rd @ 11:00 AM - 12:30 PM ET
CE Credits: 1.5 CME/1.5 CPE credits

Goal & Objectives
After completing this activity, the learner will be able to:
- Articulate the process and key steps of outlining, drafting, editing and submitting a manuscript to communicate research to the scientific community or within a current career in clinical pharmacology;
- Demonstrate newly-gained knowledge of the process of writing, reviewing, editing and revising draft scientific manuscripts in order to improve the likelihood of acceptance and provide a high-quality revised manuscript;
- Recognize different manuscript formats (brief reports, short communication, expert opinion, full-length article and review article) and appropriate supporting documents/supplemental material that are necessary to effectively communicate scientific research results;
- Deepen the expertise and understanding of the differences between journals and to choose the appropriate journal in order for research to achieve the best exposure/impact;
- Recognize potential of target journal being a predatory or opportunistic journal.

Register: http://bit.ly/2FlzL2e
#pharmacology #CE

fda.gov

Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength

MedWatch Safety Alert: Mirtazapine Tablets by Aurobindo Pharma USA: Recall - Due to Label Error on Declared Strength

Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.

http://bit.ly/37pSBB2

fda.gov Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.

washingtonpost.com

‘Miss America can be a scientist’: Camille Schrier of Virginia wins after onstage chemistry experiment

PharmD Student at VCU School of Pharmacy wins Miss America!

washingtonpost.com The revamped show emphasizes interviews and social impact initiatives over bikinis and evening gowns.

Reminder - January #ACCPVJC Webinar: Characterization of Severe Adverse Drug Reactions at a Free-Standing Children’s Hospital

Date: Wednesday, January 22, 2020
Time: 2:00 - 3:00 PM (ET)
Faculty: Jennifer Goldman, MD, Associate Professor, Pediatrics, Infectious Diseases and Clinical Pharmacology, Children's Mercy Kansas City and Sarah Suppes, PharmD, Clinical Pharmacy Specialist, Div of Clinical Pharmacology, Toxicology & Therapeutic Innovation, Children's Mercy Kansas City
Register: http://bit.ly/ACCPVJC
#pharmacology #CE

www.accessdata.fda.gov

FDA Approves OXBRYTA (Voxelotor) for the Treatment of Sickle Cell Disease in Adults and Pediatric Patients 12 Years of Age and Older

On November 25, 2019, the U.S. Food and Drug Administration (FDA) approved OXBRYTA (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). The approved recommended dosage of OXBRYTA is 1,500 mg taken orally once daily with or without food. OXBRYTA may be given with or without hydroxyurea.

OXBRYTA is contraindicated in patients with a history of serious drug hypersensitivity reaction to voxelotor or excipients. Additional information regarding dosage and administration, laboratory test interference, and important warnings and precautions about hypersensitivity reactions can be found in the full prescribing information linked below.

Mechanism of Action (MOA), Pharmacokinetics (PK), and Pharmacodynamics (PD)

• MOA: Voxelotor is a hemoglobin S (HbS) polymerization inhibitor.
• General PK: Voxelotor exposures increased proportionally with either single or multiple doses in whole blood, plasma, and RBCs. Steady-state after repeated administration is reached within 8 days and exposures of voxelotor are consistent with accumulation predicted based on single dose data in patients with SCD. The geometric mean (%CV) AUC0-24h and Cmax of voxelotor in plasma were 246 (27.7) μghr/mL and 12.6 (24.8) µg/mL, respectively. The geometric mean (%CV) AUC0-24h and Cmax of voxelotor in whole blood were 3820 (35) μghr/mL and 179 (33.1) µg/mL, respectively.
• Absorption: The median plasma and whole blood Tmax of voxelotor after oral administration is 2 hours. The mean peak concentrations in whole blood and RBCs are observed between 6 and 18 hours after oral administration.
• Distribution: Voxelotor apparent volume of distribution of the central compartment and peripheral compartment are 338 L and 72.2 L in plasma, respectively. Protein binding is 99.8% in vitro. Voxelotor is distributed predominantly into RBCs due to its preferential binding to Hb; the blood-to-plasma ratio is approximately 15:1 in patients with SCD.
• Elimination: The geometric mean (%CV) terminal elimination half-life of voxelotor in patients with SCD is 35.5 hours (25%) with concentrations in plasma, whole blood, and RBCs declining in parallel. The apparent oral clearance of voxelotor was estimated as 6.7 L/h in plasma in patients with SCD.
• Metabolism: Voxelotor is metabolized through Phase I (oxidation and reduction), Phase II (glucuronidation), and combinations of Phase I and II metabolism. Oxidation of voxelotor is mediated primarily by CYP3A4, with minor contribution from CYP2C19, CYP2B6, and CYP2C9.
• Excretion: Following the administration of radiolabeled voxelotor, approximately 62.6% of the dose and its metabolites are excreted into feces (33.3% unchanged) and 35.5% in urine (0.08% unchanged).
• PD: The pharmacodynamic effect of voxelotor treatment demonstrated a dose-dependent increase in Hb oxygen affinity as determined by the change in p50 (partial pressure of oxygen at which Hb oxygen saturation of 50% is achieved) that was linearly correlated with voxelotor exposure. The pharmacodynamic effect of voxelotor treatment also demonstrated a dose-dependent reduction in clinical measures of hemolysis (indirect bilirubin and % reticulocytes).

Drug Interactions

• Strong CYP3A4 Inhibitors or Fluconazole: Avoid co-administration of OXBRYTA with strong CYP3A4 inhibitors or fluconazole and replace these drugs with alternative drugs when possible. If co-administration is unavoidable, decrease the OXBRYTA dosage to 1,000 mg once daily. Co-administration of strong CYP3A4 inhibitors or fluconazole may increase voxelotor plasma concentrations and may lead to increased toxicity.
• Strong or Moderate CYP3A4 Inducers: Avoid co-administration of OXBRYTA with strong or moderate CYP3A4 inducers. If co-administration is unavoidable, increase the OXBRYTA dosage to 2,500 mg once daily. Co-administration of strong or moderate CYP3A4 inducers may decrease voxelotor plasma concentrations and may lead to reduced efficacy.
• Sensitive CYP3A4 Substrate: Avoid co-administration of OXBRYTA with sensitive CYP3A4 substrates with a narrow therapeutic index. If co-administration is unavoidable, consider dose reduction of the sensitive CYP3A4 substrate(s). Voxelotor increased the systemic exposure of midazolam (a sensitive CYP3A4 substrate).
• Laboratory Test Interference: If precise quantitation of Hb species is required, chromatography should be performed when the patient is not receiving OXBRYTA therapy. OXBRYTA administration may interfere with measurement of Hb subtypes (HbA, HbS, and HbF) by high-performance liquid chromatography.

Use in Specific Populations

No clinically significant differences in the pharmacokinetics of voxelotor were observed based on age (12 to 59 years), sex, body weight (28 to 135 kg), or mild to severe renal impairment (creatinine clearance 15-89 mL/min). OXBRYTA has not been evaluated in patients with end stage renal disease requiring dialysis.

• Pediatric Patients: The pharmacokinetic parameters of voxelotor were similar in pediatric patients 12 to < 17 years and adults.
• Patients with Hepatic Impairment: The recommended dosage of OXBRYTA in patients with severe hepatic impairment (Child Pugh C) is 1,000 mg taken once daily with or without food. No dosage adjustment of OXBRYTA is required for patients with mild or moderate hepatic impairment (Child Pugh A or B). The voxelotor AUC in whole blood were 14% and 15% higher in subjects with mild and moderate hepatic impairment (Child Pugh A and B) and 90% higher in subjects with severe hepatic impairment (Child Pugh C) compared to subjects with normal hepatic function.
• Lactation: Advise patients that breastfeeding is not recommended during treatment with OXBRYTA, and for at least 2 weeks after the last dose.

Efficacy and Safety

Efficacy of OXBRYTA was evaluated in a randomized, double-blind, placebo-controlled, multicenter trial in patients with SCD. Efficacy was based on Hb response rate defined as a Hb increase of > 1 g/dL from baseline to Week 24. Additional information regarding the efficacy trial can be found in the full prescribing information linked below.

The most common adverse reactions (incidence > 10%) are headache, diarrhea, abdominal pain, nausea, fatigue, rash, and pyrexia.
________________________________________
Full prescribing information is available at http://bit.ly/2PZ1L0k.

accessdata.fda.gov

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21750 Red Rum Dr, Ste 137
Ashburn, VA
20147

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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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