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,

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.

fda.gov

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA

FDA MedWatch - Nizatidine Oral Solution, 15 mg/mL by Amneal: Recall

TOPIC: Nizatidine Oral Solution, 15 mg/mL by Amneal: Recall - Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Amneal Pharmaceuticals is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL.

Nizatidine Oral Solution is being recalled due to potential NDMA amounts exceeding the levels established by the FDA. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

Amneal Pharmaceuticals has not received any reports of adverse events directly related to this recall.

BACKGROUND: Nizatidine Oral Solution is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

RECOMMENDATION: Patients taking prescription nizatidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as nizatidine.

Read Recall: https://bit.ly/3ckLjkC

fda.gov Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Phar

2020 ACCP Annual Meeting Pre-meeting Workshops | Saturday, September 19th

Don't forget to register for a Pre-meeting Workshop at the #2020ACCP Annual Meeting! The Workshops are held on Saturday, September 19th, prior to the 3-day meeting. All Pre-meeting Workshops offer CME & CPE credit at no additional cost. Space is limited so be sure to register early! Program Overview: https://bit.ly/2VGpXaX

• Pre-meeting Workshop 1: Analysis & Reporting of QTc Prolongation Potential of New Drugs Using R Tools, Expectations & General Guidance for Regulatory Submissions

• Pre-meeting Workshop 2: Individualized Drug Therapy: Maximally-precise Drug Therapy for Each Individual Patient, at the Bedside, in a Community Hospital Setting

• Pre-meeting Workshop 3: A Beginner Level Workshop on the Principles of Population Pharmacokinetics & Fundamentals of NONMEM® Software for Students, Trainees & Early-stage Professionals

• Pre-meeting Workshop 4: Drug Development for Pregnant Women & Their Infants: Lessons Learned from HIV

• Pre-meeting Workshop 5: Innovative Drug Development in Asia: Challenges & Opportunities

We look forward to seeing you in Bethesda!
#CME #CPE #annualmeeting #pharmacology

Clinical Pharmacology in Drug Development, April 2020 Volume 9, Issue 3 is now available!

*Commentary*
Lasmiditan: Its Development and Potential Use
Amanda E. Macone, Michael D. Perloff
Pages: 292-296 | First Published: 05 February 2020

*Articles*
Single‐ and Multiple‐Dose Safety, Tolerability, and Pharmacokinetic Profiles of ASP8062: Results From 2 Phase 1 Studies
Mark Walzer, Gerard J. Marek, Ruishan Wu, Masanori Nagata, David Han
Pages: 297-306 | First Published: 11 January 2020

A Thorough QT Study to Evaluate the Effects of a Supratherapeutic Dose of Sertraline on Cardiac Repolarization in Healthy Subjects
Richat Abbas, Steve Riley, Robert R. LaBadie, Mary Bachinsky, Phillip B. Chappell, Penelope H. Crownover, Bharat Damle
Pages: 307-320 | First Published: 27 November 2019

Preemptive Anti–Stress Response Effects of Oxycodone Versus Sufentanil for Patients Undergoing Cardiac Valve Replacement—A Randomized Controlled Trial
Jian Zhang, Qing Tu, Jianhui Gan, Shuai Miao, Ying Zhou, Qiang Li, Chuandong Zheng
Pages: 321-329 | First Published: 09 December 2019

Assessment of Bezlotoxumab Immunogenicity
Diana L. Montgomery, Randolph P. Matthews, Ka Lai Yee, Lori M. Tobias, Mary Beth Dorr, Rebecca E. Wrishko
Pages: 330-340 | First Published: 14 August 2019

Pharmacokinetics and Bioequivalence Studies of Teriflunomide in Healthy Iranian Volunteers
Mohammad‐Reza Rouini, Maryam Dibaei, Elham Ghasemian
Pages: 341-345 | First Published: 05 August 2019

Bioequivalence Study of 2 Formulations of Rivaroxaban, a Narrow‐Therapeutic‐Index Drug, in Healthy Chinese Subjects Under Fasting and Fed Conditions
Sijia Ding, Lu Wang, Lijun Xie, Sufeng Zhou, Juan Chen, Yuqing Zhao, Wenjie Deng, Yun Liu, Hongwen Zhang, Feng Shao
Pages: 346-352 | First Published: 14 October 2019

A 3‐Part Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DSP‐6952 in Healthy Japanese Subjects and Those With ≤3 Spontaneous Bowel Movements per Week
Takuya Yumizaki, Mika Maeda, Tomoe Fujita, Hiroyoshi Kakuyama, Yuji Kumagai
Pages: 353-365 | First Published: 28 August 2019

A First‐in‐Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers
Zadik Hazan, Konstantin Adamsky, Andre Lucassen, Leonard A. Levin
Pages: 366-374 | First Published: 28 June 2019

The Pharmacokinetics and Relative Bioavailability of Mepolizumab 100 mg Liquid Formulation Administered Subcutaneously to Healthy Participants: A Randomized Trial
Shaila Shabbir, Isabelle J. Pouliquen, Jane H. Bentley, Eric S. Bradford, Morrys C. Kaisermann, Muna Albayaty
Pages: 375-385 | First Published: 17 July 2019

Pharmacokinetic and Safety Profiles of a Fixed‐Dose Combination of Amlodipine, Valsartan, and Atorvastatin: A 3‐Period Replicate Crossover Study
Seokuee Kim, Jae‐Wook Ko, Jung‐Ryul Kim
Pages: 386-394 | First Published: 02 August 2019

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Non–Bile Acid FXR Agonist Tropifexor (LJN452) in Healthy Volunteers
Michael K. Badman, Jin Chen, Sachin Desai, Soniya Vaidya, Srikanth Neelakantham, Jie Zhang, Lu Gan, Kate Danis, Bryan Laffitte, Lloyd B. Klickstein
Pages: 395-410 | First Published: 10 December 2019

Phase 1 Pharmacokinetic Study of AZD5718 in Healthy Volunteers: Effects of Coadministration With Rosuvastatin, Formulation and Food on Oral Bioavailability
Hans Ericsson, Karin Nelander, Maria Heijer, Magnus Kjaer, Eva‐Lotte Lindstedt, Muna Albayaty, Pablo Forte, Maria Lagerström‐Fermér, Stanko Skrtic
Pages: 411-421 | First Published: 02 December 2019

www.accessdata.fda.gov

FDA Burst: FDA Approves KOSELUGO (selumetinib) for the Treatment of Pediatric Patients 2 Years of Age and Older with Neurofibromatosis Type 1 who Have Symptomatic, Inoperable Plexiform Neurofibromas

On April 10, 2020, the U.S. Food and Drug Administration (FDA) approved KOSELUGO (selumetinib) for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The approved recommended dosage of KOSELUGO is 25 mg/m2 orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity. Take KOSELUGO on an empty stomach. Do not consume food 2 hours before each dose or 1 hour after each dose.

Additional information regarding dosage and administration, including dosage modifications for adverse reactions, as well as important warnings and precautions about cardiomyopathy, ocular toxicity, gastrointestinal toxicity, skin toxicity, increased creatinine phosphokinase, increased levels of vitamin E and risk of bleeding, and embryo-fetal toxicity can be found in the full prescribing information linked below.

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

• MOA: Selumetinib is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2).

• General PK: At the recommended dosage of 25 mg/m2 twice daily in pediatric patients (2 to ≤ 18 years old), the mean Cmax (CV%) following the first dose was 731 (62%) ng/mL and at steady state was 798 (52%) ng/mL. The mean AUC0-12h following the first dose was 2009 (35%) ng•h/mL and the AUC0-6h at steady state was 1958 (41%) ng•h/mL. Selumetinib AUC and Cmax increases proportionally over a dose range from 20 mg/m2 to 30 mg/m2 (0.8 to 1.2 times the recommended dose). The accumulation was 1.1-fold following administration of KOSELUGO 25 mg/m2 twice daily.

• Absorption: The mean absolute oral bioavailability of selumetinib was 62% in healthy adults. The median time to peak plasma concentrations (Tmax) at steady-state in pediatric patients was 1 to 1.5 hours.

• Effect of Food: Mean Cmax and AUC of selumetinib decreased by 50% and 16%, respectively, following a high-fat meal (1000 calories, 50% fat) in healthy adults administered a single-dose of 75 mg (1.5 times the approved maximum recommended dosage). Tmax was delayed by approximately 1.5 hours following a high-fat meal. Selumetinib Cmax and AUC decreased by 60% and 38%, respectively, following a low-fat meal (400 calories, 25% fat) in healthy adults administered a single-dose of 50 mg. Tmax was delayed by approximately 0.9 hours following a low-fat meal.

• Distribution: The mean apparent volume of distribution of selumetinib across a dose range of 20 mg/m2 to 30 mg/m2 (0.8 to 1.2 times the recommended dosage) at steady state ranged from 78 L to 171 L in pediatric patients. The plasma protein binding was 98.4% in humans in vitro. Selumetinib binds to serum albumin (96%) and α-1 acid glycoprotein (< 35%).

• Elimination: In pediatric patients, selumetinib had a mean elimination half-life of approximately 6.2 hours and an apparent oral clearance of 8.8 L/hr.

• Metabolism: Selumetinib is primarily metabolized by CYP3A4 and to a lesser extent by CYP2C19, CYP1A2, CYP2C9, CYP2E1, and CYP3A5. Selumetinib also undergoes glucuronidation by UGT1A1 and UGT1A3. The active metabolite, N-desmethyl selumetinib is approximately 3 to 5 times more potent than the parent compound, contributing to about 21% to 35% of the overall pharmacologic activity.

• Excretion: After a single oral dose of radiolabeled selumetinib 75 mg (1.5 times the recommended dose) to healthy adults, 59% of the dose was recovered in feces (19% as unchanged) and 33% in urine (< 1% as parent).

Drug Interactions

• Strong or Moderate CYP3A4 Inhibitors or Fluconazole: Avoid coadministration of strong or moderate CYP3A4 inhibitors or fluconazole with KOSELUGO. If coadministration with strong or moderate CYP3A4 inhibitors or fluconazole cannot be avoided, reduce the dose of KOSELUGO. Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inhibitor or fluconazole increased selumetinib plasma concentrations which may increase the risk of adverse reactions.

• Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of strong and moderate CYP3A4 inducers. Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inducer decreased selumetinib plasma concentrations, which may reduce KOSELUGO efficacy.

• Vitamin E: Supplemental vitamin E is not recommended if daily vitamin E intake (including the amount of vitamin E in KOSELUGO and supplement) will exceed the recommended or safe limits. Monitor for bleeding in patients coadministered a vitamin-K antagonist or an anti-platelet agent with KOSELUGO. Increase INR monitoring, as appropriate, in patients taking a vitamin-K antagonist. KOSELUGO contains vitamin E and daily vitamin E intake that exceeds the recommended or safe limits may increase the risk of bleeding. An increased risk of bleeding may occur in patients taking a vitamin-K antagonist or an anti-platelet agent with KOSELUGO.

Use in Specific Populations

No clinically meaningful effect on the pharmacokinetics of selumetinib or N-desmethyl selumetinib were observed based on race (White, Asian, Black), renal impairment, or end stage renal disease (CLcr < 15 mL/min) requiring dialysis.

• Hepatic Impairment: Reduce the dose of KOSELUGO for patients with moderate hepatic impairment (Child-Pugh B). A recommended dosage of KOSELUGO for use in patients with severe hepatic impairment (Child-Pugh C) has not been established. Selumetinib exposures increased in patients with moderate or severe hepatic impairment but did not show clinically meaningful change in patients with mild hepatic impairment (Child-Pugh A).

• Lactation: Due to the potential for adverse reactions in a breastfed child, advise women not to breastfeed during treatment with KOSELUGO and for 1 week after the last dose.

Efficacy and Safety

Efficacy of KOSELUGO was demonstrated in an open-label, multicenter, single arm trial that enrolled pediatric patients who had NF1 with inoperable PN. The major efficacy outcome measure was overall response rate (ORR), defined as the percentage of patients with complete response (defined as disappearance of the target PN) or confirmed partial response (defined as ≥ 20% reduction in PN volume confirmed at a subsequent tumor assessment within 3-6 months). Additional information regarding the efficacy trial can be found in the full prescribing information linked below.

The most common adverse reactions (≥ 40%) are: vomiting, rash (all), abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, pyrexia, acneiform rash, stomatitis, headache, paronychia, and pruritus.
________________________________________
Full prescribing information is available at https://bit.ly/2yfSHPy.

accessdata.fda.gov

Call for 2021 Proposals Workshops & Symposia | #2021ACCP Annual Meeting | Sept 12 – 14, 2021 | Renaissance Phoenix Downtown Hotel, Phoenix, AZ

ACCP is now accepting Proposals for the 2021 ACCP Annual Meeting, "Spearheading Innovations in Clinical Pharmacology"!

Areas of submission will be categorized into the following tracks: Basic Research & Drug Development, Patient Centric & Both: Basic Research/Drug Development & Patient Centric.

Learn more: https://bit.ly/2V5VgMZ
#callforproposals #annualmeeting #pharmacology

➡️ Only One Week until the April ACCP Webinar: Tips & Tricks for Effective Presentations ⬅️

Tuesday, April 21st @ 2 PM ET | 1 CME or 1 CPE credit

Register today! https://bit.ly/2Uf7QsX
#pharmacology #CME #CPE

⚠️ 24 Hours Left to Submit Your Abstract | #2020ACCP Annual Meeting | Sept 20 - 22 | Bethesda N Marriott Hotel & Conf Ctr

April 15th at 11:59 PM ET is the deadline! http://bit.ly/2FSYYBk
#pharmacology #conference #annualmeeting #abstract

fda.gov

Ivermectin Intended for Animals: Safety Alert - Do Not Use in Humans

FDA MedWatch - Ivermectin Intended for Animals: Letter to Stakeholders

TOPIC: Ivermectin Intended for Animals: Letter to Stakeholders - Do Not Use in Humans as a Treatment for COVID-19

AUDIENCE: Consumer, Health Professional, Pharmacy, Veterinary

ISSUE: FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be a substitute for ivermectin intended for humans.

BACKGROUND: The FDA’s Center for Veterinary Medicine has recently become aware of increased public visibility of the antiparasitic drug ivermectin after the announcement of a research article that described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. The Antiviral Research pre-publication paper, “The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro” documents how SARS-CoV-2 (the virus that causes COVID-19) responded to ivermectin when exposed in a petri dish. These types of laboratory studies are commonly used at an early stage of drug development.

No ivermectin was administered to humans in this study. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.

RECOMMENDATION:
• Ivermectin is not approved for the treatment of COVID-19. People should not take any form of ivermectin unless it has been prescribed by a licensed health care provider and is obtained through a legitimate source.
• People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular animal species for which they are labeled. These animal drugs can cause serious harm in people.
• Ivermectin tablets are approved for use in humans for the treatment of some parasitic worms (intestinal strongyloidiasis and onchocerciasis) and ivermectin topical formulations are approved for human use by prescription only for the treatment of external parasites such as headlice and for skin conditions such as rosacea.

Please help us protect public health by alerting FDA of anyone claiming to have a product to prevent or cure COVID-19 and to help safeguard human and animal health by reporting any of these products to [email protected] or 1-888-InfoFDA (1-888-463-6332).
https://bit.ly/2XDBcmK

fda.gov FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be a substitute for ivermectin intended for humans.

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21750 Red Rum Dr, Ste 137
Ashburn, VA
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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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