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.

Don't Forget to Submit Your Abstract for the 2019 ACCP Annual Meeting (#2019ACCP)!

The deadline is April 15th at 11:59 PM ET. Accepted abstracts will also be published online in Clinical Pharmacology in Drug Development!
http://bit.ly/2MfgiTB

[Today @ 2PM ET] #ACCPVJC Webinar | Calcineurin Inhibitor and Nonsteroidal Anti-inflammatory Drug Interaction: Implications of Changes in Renal Function Associated With Concurrent Use

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

⏰ [Tomorrow: March 13th @ 2PM ET] #ACCPVJC Webinar | Calcineurin Inhibitor and Nonsteroidal Anti-inflammatory Drug Interaction: Implications of Changes in Renal Function Associated With Concurrent Use

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

accp1.org

Measles, once considered eliminated in the US, is on the rise. Joseph S.Bertino Jr., PharmD, FCP, Editor-in-Chief, The Journal of Clinical Pharmacology (JCP) addressed this very issue in a commentary article entitled “Measles Vaccine: Time to Stop the Madness”
(http://bit.ly/2EQvgfm) first published January 18, 2016. Due to the present Measles epidemic in the US and abroad this an important piece to share again.

In the same JCP issue, the article “Measles Vaccine: Past, Present and Future” (http://bit.ly/2J5sQPl) authored by Philip Zachariah, MD, MS and Melissa S. Stockwell, MD, MPH provides a thorough overview of the Measles vaccine. Both articles are important to review considering today’s Measles’s health crisis.

accp1.org

Travel Support Provided for Top 16 Student Abstracts at 2019 ACCP Annual Meeting!

ACCP is pleased to announce that it will provide up to $500 of travel support for each of the top 16 Student Abstracts submitted for the 2019 ACCP Annual Meeting (#2019ACCP)! In addition, the top 8 Student Abstracts will receive complimentary registration to the 3-Day Annual Meeting, a $1,000 honorarium, an invitation to attend the Honors & Awards/Regents Dinner and a trophy.

If you know someone that may be interested please do not hesitate to share this information!

For additional information on Student Abstract Awards visit: http://bit.ly/2U9iZJw

To submit a Student Abstract visit: http://bit.ly/2MfgiTB

⏰ Time is Ticking By...Be sure to register for the March 13th #ACCPVJC: Calcineurin Inhibitor and Nonsteroidal Anti-inflammatory Drug Interaction: Implications of Changes in Renal Function Associated With Concurrent Use

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

The Journal of Clinical Pharmacology - March 2019, Vol 59, Issue 3 is now available!

*Continuing Education: Review*
Population Pharmacokinetics of Tacrolimus in Transplant Recipients: What Did We Learn About Sources of Interindividual Variabilities?
Olivia Campagne PharmD, PhD, Donald E. Mager PharmD, PhD, Kathleen M. Tornatore PharmD
Pages: 309-325 | First Published: 29 October 2018

*Therapeutics*
Effects of Conversion From Calcineurin Inhibitors to Sirolimus or Everolimus on Renal Function and Possible Mechanisms in Liver Transplant Recipients
Kai‐Fan Tsai MD, Lung‐Chih Li MD, PhD, Chien‐Ning Hsu PhD, Chih‐Che Lin MD, PhD, Yu‐Hung Lin MD, Yu‐Fan Cheng MD, Chih‐Chi Wang MD, Chao‐Long Chen MD
Pages: 326-334 | First Published: 02 November 2018

*Editor's Choice: Pharmacoepidemiology*
Androgen Deprivation Therapy Use Increases the Risk of Heart Failure in Patients With Prostate Cancer: A Population‐Based Cohort Study
Hui‐Han Kao MBA, Li‐Ting Kao PhD, I‐Hsun Li PhD, Ke‐Ting Pan MS, Jui‐Hu Shih PhD, Yu‐Ching Chou PhD, Sheng‐Tang Wu MD
Pages: 335-343 | First Published: 07 November 2018

*Pharmacoepidemiology*
Association Between Pioglitazone Use and Prostate Cancer: A Population‐Based Case‐Control Study in the Han Population
Li‐Ting Kao PhD, Sudha Xirasagar PhD, MBBS, Herng‐Ching Lin PhD, Chao‐Yuan Huang MD, PhD
Pages: 344-349 | First Published: 17 October 2018

Negative Association of Proton Pump Inhibitors With Subsequent Development of Breast Cancer: A Nationwide Population‐Based Study
Chao‐Hung Chen MD, PhD, Cha‐Ze Lee MD, PhD, Yi‐Chun Lin MA, Li‐Ting Kao PhD, Herng‐Ching Lin PhD
Pages: 350-355 | First Published: 17 October 2018

*Pharmacovigilance*
Analyses of Adverse Drug Reactions–Nationwide Active Surveillance Network: Canadian Pharmacogenomics Network for Drug Safety Database
Reo Tanoshima MD, PhD, Amna Khan BSc, Agnieszka K. Biala MPharm, PhD, Jessica N. Trueman MSc, Britt I. Drögemöller PhD, Galen E. B. Wright PhD, Jafar S. Hasbullah BSc, Gabriella S. S. Groeneweg MA, Colin J. D. Ross MSc, PhD, Bruce C. Carleton PharmD, on behalf of the Canadian Pharmacogenomics Network for Drug Safety Consortium
Pages: 356-363 | First Published: 19 November 2018

*Pharmacometrics*
Population Pharmacokinetics and Exposure — Safety Analyses of Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Xiaoli Wang PhD, Elizabeth A. Ludwig PharmD, Julie Passarell MA, Akintunde Bello PhD, Amit Roy PhD, Matthew W. Hruska PharmD PhD
Pages: 364-373 | First Published: 19 October 2018

Population Pharmacokinetic Modeling to Evaluate Standard Magnesium Sulfate Treatments and Alternative Dosing Regimens for Women With Preeclampsia
Lihong Du PhD, Larissa Wenning PhD, Elizabeth Migoya PharmD, Yan Xu PhD, Brendan Carvalho MDCH, Kathleen Brookfield MPH, Han Witjes PhD, Rik de Greef MSc, Pisake Lumbiganon MS, Ussanee Sangkomkamhang, Vitaya Titapant MD, Lelia Duley FRCOG, Qian Long PhD, Olufemi T. Oladapo FWACS
Pages: 374-385 | First Published: 13 November 2018

*Women's Health*
Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum
Ahizechukwu C. Eke MD, MPH, Shelley A. McCormack MD, Brookie M. Best PharmD, MAS, Alice M. Stek MD, Jiajia Wang MS, Regis Kreitchmann MD, PhD, David Shapiro PhD, Elizabeth Smith MD, Lynne M. Mofenson MD, Edmund V. Capparelli PharmD, Mark Mirochnick MD, IMPAACT P1026s Protocol Team
Pages: 386-393 | First Published: 25 October 2018

*Pharmacokinetics*
General Pharmacokinetic Features of Small‐Molecule Compounds Exhibiting Target‐Mediated Drug Disposition (TMDD): A Simulation‐Based Study
Thanh Bach BA, Yu Jiang PhD, Xiaoyan Zhang PhD, Guohua An MD, PhD
Pages: 394-405 | First Published: 02 November 2018

*Pediatric Pharmacology*
Simulations of Valproate Doses Based on an External Evaluation of Pediatric Population Pharmacokinetic Models
Manon Tauzin MD, Jean‐Marc Tréluyer MD, PhD, Rima Nabbout MD, PhD, Thierry Billette de Villemeur MD, PhD, Isabelle Desguerre MD, PhD, Radia Aboura PharmD, Ines Gana PharmD, PhD, Yi Zheng MSc, Sihem Benaboud PharmD, PhD, Naim Bouazza PhD, Camille Chenevier‐Gobeaux PharmD, Cécile Freihuber MD, Déborah Hirt PharmD, PhD
Pages: 406-417 | First Published: 09 November 2018

*Special Populations*
Definition and Validation of a Novel Metric of Erythropoiesis‐Stimulating Agent Response in Hemodialysis Patients
Calvin J. Meaney PharmD, Spinel Karas PharmD, Ben Robinson PharmD, Jamie Gaesser PharmD, Alan Forrest PharmD, Wojciech Krzyzanski PhD, Mandip Panesar MD, Gauri G. Rao PharmD
Pages: 418-426 | First Published: 09 November 2018

Moderate Renal Impairment Does Not Impact the Ability of CSL112 (Apolipoprotein A‐I [Human]) to Enhance Cholesterol Efflux Capacity
Andreas Gille MD, PhD, Danielle Duffy MD, Michael A. Tortorici PharmD, PhD, Samuel D. Wright PhD, Lawrence I. Deckelbaum MD, Denise M. D'Andrea MD
Pages: 427-436 | First Published: 19 November 2018

*Erratum*
Erratum
Pages: 437 | First Published: 05 February 2019

http://bit.ly/2tOl1Ue #ACCPJCP

Only 2 Weeks to the #ACCPVJC: Calcineurin Inhibitor and Nonsteroidal Anti-inflammatory Drug Interaction: Implications of Changes in Renal Function Associated With Concurrent Use

March 13th @ 2 PM ET
We hope to see you there! Register Today: http://bit.ly/ACCPVJC

www.fda.gov

FDA Announces Availability of a Draft Guidance: “Bioavailability Studies Submitted in NDAs or INDs — General Considerations”

On February 25, 2019, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations”. This guidance provides recommendations to sponsors submitting bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements.

This guidance contains advice on how to meet the BA regulatory requirements as they apply to dosage forms intended for oral administration. The guidance is also applicable to non-orally administered drug products when it is appropriate to rely on systemic exposure measures to determine the BA of a drug (e.g., transdermal delivery systems and certain rectal and nasal drug products). It provides advice on conducting relative BA studies during the IND period for a drug intended to be submitted for approval in an NDA and bioequivalence (BE) studies during the post-approval period for certain changes to drug products. The guidance outlines recommendations regarding considerations for study design, assessing BA for various dosage forms, information on in vitro approaches, and discusses special topics.

Determining the BA of formulations is important during the life cycle of drug products and aids in the FDA’s evaluation of the safety and effectiveness of a product in an IND, NDA, or NDA supplements. BA is defined as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. BA data provide an estimate of the fraction of the drug absorbed as well as information related to the pharmacokinetics of the drug, such as distribution, metabolism, excretion, the effects of food on the absorption of the drug, dose proportionality or linearity in the pharmacokinetics of the active moieties and, when appropriate, inactive moieties.

When finalized, this guidance will revise and replace the FDA’s March 2014 draft guidance for industry entitled “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations”, which addresses BA or BE studies for INDs, NDAs, and NDA supplements. The FDA recognizes that the “Bioavailability Studies Submitted in NDAs or INDs — General Considerations” guidance cannot address every issue pertaining to the assessment of BA studies for INDs and NDAs. Therefore, sponsors are encouraged to contact the appropriate review division for guidance on specific questions not addressed by this guidance.

The “Bioavailability Studies Submitted in NDAs or INDs — General Considerations” guidance is available at http://bit.ly/2IEPga3. Please refer to the guidance for more details.

FDA is publishing this draft guidance to collect additional public comments. You may submit your comments to the draft guidance by May 28, 2019 to the docket (Docket No. FDA-2018-D-4367) available at http://bit.ly/2IA280P. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience, and make your voice count.

fda.gov

www.fda.gov

FDA Announces Availability of a Draft Guidance: “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations”

On February 25, 2019, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations”. This guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug applications (NDAs), and supplements to these applications. The guidance contains recommendations for the conduct, timing, and design of FE studies as well as considerations for data analysis and labeling.

Food-drug interactions can have a significant impact on the safety and efficacy of the drug. These effects can be manifested in different ways. During new drug development, pharmacokinetic studies to assess the effect of food on the systemic exposure of the drug are conducted to determine: (1) if, and to what extent, food impacts the systemic exposure of the drug; (2) whether food increases or decreases the variability of the systemic exposure of the drug; and (3) if the effect of food is different across meals with different fat or caloric contents.

It is important to have a detailed understanding of the exposure-response relationships of the drug to interpret the results of FE studies. For example, the observed increase or decrease in the systemic exposures of some drugs in the presence of food may not be clinically relevant based on exposure-response information. In other cases, the clinical pharmacology characteristics of the drug may suggest that it should be administered only under fasted conditions (e.g., when higher exposures under fed conditions raise the risk of a clinically significant adverse reaction). Some drugs have undesired side 68effects that can be alleviated when taken with a meal. Food may increase absorption, and co-administration with food may be the only practical means of enhancing the efficacy of the drug in patients.

This guidance revises and replaces part of the 2002 FDA guidance for industry entitled “Food-Effect Bioavailability and Fed Bioequivalence Studies”. Information on fed BE studies to be submitted in abbreviated new drug applications (ANDAs) is now found in the FDA guidance for industry entitled “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA”. Specific recommendations concerning fed comparability trials are now described in the FDA guidance for industry entitled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations”. Sponsors are strongly encouraged to engage FDA staff early in the development of a new drug regarding the strategy and details of FE studies.

The “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations” guidance is available at http://bit.ly/2IA29lp. Please refer to the guidance for more details.

FDA is publishing this draft guidance to collect additional public comments. You may submit your comments to the draft guidance by April 29, 2019 to the docket (Docket No.FDA-2018-D-4368) available at http://bit.ly/2IA280P. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience, and make your voice count.

fda.gov

Student Highlight Interview - Alex Prokopienko, PharmD

This month's Student Highlight Interview focuses on Alex Prokopienko, PharmD. Alex is currently an active member on the Education Committee and Student, Trainee & Young Professional Committee. In addition to his involvement in ACCP, Dr. Prokopienko was an ACCP Student Abstract Award Winner in 2018.

Dr. Prokopienko is currently a PhD Candidate at the University of Pittsburgh School of Pharmacy. He is a clinical/translational researcher focusing on targeting novel cardiovascular disease risk factors in patients with kidney disease. Alex’s experiences include preclinical pharmacology research Phase 0-3 trials, clinical data review, study management and empowering study teams. He plans to graduate with his PhD in Pharmaceutical Sciences this summer. His short-term career goal is to pursue a clinical pharmacology or clinical sciences based position within academia or industry.

Dr. Prokopienko has kindly shared his thoughts on how involvement in ACCP has shaped his career and the benefits he has enjoyed as a result of being an ACCP Member: "I had the honor to be selected as a 2018 ACCP Student Abstract Award winner. I also presented my work as a podium presentation. In addition, I serve on the Student, Trainee & Young Professional Committee and on the Education Committee. These opportunities are shaping my career by allowing me to develop professional skill sets like effective communication and teamwork."

Thank you for your support Dr. Prokopienko! http://bit.ly/2ItNF6Q

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

fda.gov FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this....

Do you ❤️ your job? If not, there are plenty of new opportunities to select from on the #ACCPJOBCTR. Be sure to check them out...http://bit.ly/2J0TTKj

Uloric (febuxostat): Boxed Warning Added - Due to Increased Risk of Death with Gout Medicine

fda.gov FDA has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Ul...

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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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