American College of Clinical Pharmacology

Clinical Pharmacology in Drug Development, July 2023 Volume 12, Issue 7 is now available!
https://bit.ly/3PNzf2u


Commentary
Anti‐Monkeypox Infection Approaches: From Prevention to Therapeutic Lines
Somayeh Ghafari, Mohammad Rezaei Zadeh Rukerd, Davood Bashash, Mohsen Nakhaie, Javad Charostad, Mohammad Zarei, Azam Dehghani
Pages: 659-666 | First Published: 25 May 2023

Articles
Evaluation of Drug–Drug Interaction Potential of Enarodustat (JTZ‐951) Using a Cytochrome P450 Probe Cocktail
Sudhakar M. Pai, Hiroyuki Yamada, Hiroyuki Murata
Pages: 667-682 | First Published: 02 June 2023

Pharmacokinetics of Enarodustat in Non‐Japanese and Japanese Healthy Subjects and in Patients With End‐Stage Renal Disease on Hemodialysis
Sudhakar M. Pai, Siva Rama Prasad Kambhampati, Shinya Naruhashi, Hiroyuki Yamada
Pages: 683-690 | First Published: 19 May 2023

Pharmacokinetics, Bioequivalence, and Safety of Esomeprazole Magnesium Enteric‐Coated Capsules in Healthy Chinese Subjects
Juan Jin, Cuiping Huang, Changhai Zhu, Wanni Feng, Ang He, Tuo Li, Lina Wang, Xiaolu Wang, Xiali Rao, Fangliang Gan
Pages: 691-698 | First Published: 17 June 2023

The Pharmacokinetics and Bioequivalence of Desvenlafaxine Succinate in Chinese Healthy Subjects Under Fasting and Fed States
Manman Wang, Yingying Yang, Wei Hu, Yue Wang, Youli Chen, Xueyuan Zhang
Pages: 699-705 | First Published: 27 May 2023

Phase 1 Clinical Results for NP10679, a pH‐sensitive GluN2B‐selective N‐methyl‐d‐aspartate Receptor Inhibitor
Robert Zaczek, Stephen F. Traynelis, Ray Dingledine, George W. Koszalka, Daniel T. Laskowitz
Pages: 706-717 | First Published: 15 January 2023

Pharmacokinetics of AXA1665, a Novel Composition of Amino Acids, in Comparison With Protein Supplement: A Single‐Dose, Open‐Label, Randomized Study in Healthy Subjects
Soniya Vaidya, Joshua McLinden, Paul Hinderliter, Noriaki Tatsuta, Alexandra Steinberg, Sam Rebello
Pages: 718-730 | First Published: 15 February 2023

Bioequivalence Study of Ezetimibe Tablets After a Single Oral Dose of 10 mg in Healthy Japanese Subjects Under Fasting Conditions
Shigenori Wada, Yoshiyuki Sasagane, Seiya Kagatani, Hiroaki Nakagami
Pages: 731-738 | First Published: 06 April 2023

Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study
Bonnie Shaddinger, Kelly M. Mahar, Mike Sprys, Susan M. Andrews, Sayantan Chattoraj, Rubeen Israni, Alex Cobitz
Pages: 739-748 | First Published: 01 May 2023

First‐in‐Human, Single‐ and Multiple‐Ascending‐Dose, Food‐Effect, and Absolute Bioavailability Trials to Assess the Pharmacokinetics, Safety, and Tolerability of Pritelivir, a Nonnucleoside Helicase‐Primase Inhibitor Against Herpes Simplex Virus in Healthy Subjects
Dirk Kropeit, Susanne Bonsmann, Oliver von Richter, David McCormick, Jörg Pausch, Melanie Sumner, Alexander Birkmann, Holger Zimmermann, Helga Rübsamen-Schaeff
Pages: 749-760 | First Published: 01 March 2023

A Bioequivalence Study With Pharmacokinetic Endpoints for Azithromycin Eye Drops
Feng Wu, Xiuli Zhao, Shaojie Guo, Siyang Ni, Yuyang Dai, Ying Han, Ke Ma, Yunzhe Wang
Pages: 761-766 | First Published: 22 February 2023

⚡ Reserve Your Spot Today for the Trends in Drug Development Seminar on Sept 9th from 8:00 AM to 5:30 PM PT during the Annual Meeting.

This Seminar will cover the following topics:
- Opioid Crisis in the US: A Complex Problem Requires an Innovative Approach

- Leveraging mRNA Technology for Vaccine & Therapeutics: Let's Expand the Clinical Pharmacology Paradigm

- A Quest for Aging Well: Addressing Drug Development & Safety in the US Older Adult Population

- Applications of Artificial Intelligence & Machine Learning in Clinical Pharmacology

Add the Trends in Drug Development Seminar to your Annual Meeting agenda today and take advantage of the Advance registration fee discount!

For the full agenda please visit >> https://bit.ly/3Nc5zaf

⏰ Time is running out to Submit Your Proposal for the Annual Meeting, Sept 8 – 10, 2024 in Bethesda, MD!

To learn more about the Areas of Submission & Guidelines visit: https://bit.ly/2V5VgMZ

We look forward to receiving your Proposal and encourage you to invite your colleagues to submit a Proposal by July 31st!

The Journal of Clinical Pharmacology - July 2023, Vol 63, Issue 7 is now available! https://bit.ly/3NS9RY4

*Commentary*
Assessing Pharmacokinetics in Liver Disease: Challenges and Future Considerations for Classification of Hepatic Dysfunction and Use of In Silico Methods
Martina D. Sahre PhD, Daphne Guinn PhD, Anuradha Ramamoorthy PhD, Insook Kim PhD, Xinyuan Zhang PhD, Ruby Mehta MD, Shirley Seo PhD, Mehul Mehta PhD, Joga Gobburu PhD, Rajanikanth Madabushi PhD
Pages: 755-758 | First Published: 11 March 2023

*Continuing Education: Review*
The Impact of Sedative Hypnotic Drugs on Hallucinated Sexual Assault or Sexual Fantasies Involving Health Professionals: A Systematic Review
Melody White , C. Michael White PharmD, FCP, FCCP
Pages: 759-768 | First Published: 09 March 2023

*Therapeutics*
A Retrospective Cohort Study Examining the Effects of Anti‐PD‐1 Antibody in Combination with Apatinib in Patients Previously Treated for Her2‐Negative Advanced Gastric/Gastroesophageal Junction Cancer
Xin-Fang Hou MD, Xin-Xin Zhang MM, Shuai Li MD, Chen Wu MM, Xiao-Bing Chen MD
Pages: 769-775 | First Published: 02 April 2023

A Comparative Study on Ticagrelor and Clopidogrel in Patients With Acute Coronary Syndrome Treated With Primary Percutaneous Coronary Intervention
Hui Wu MM, Shaobin Jia MD
Pages: 776-783 | First Published: 05 April 2023

*Drug Interactions*
Evaluation of the Impact of Ritlecitinib on Organic Cation Transporters Using Sumatriptan and Biomarkers as Probes
Xiaoxing Wang PhD, Vivek Purohit PhD, Martin E. Dowty PhD, David Rodrigues PhD, Lina Luo MS, Sumathy Mathialagan MS, William Carey MBBS, MRCPI, PhD, Anna Plotka MSc, Hindu Kalluru PhD, O'Gorman Melissa MPH, Julia Kaplan MS, Yeamin Huh PhD, Manoli Vourvahis PharmD, Robert M. Wolk MD, PhD, DSc
Pages: 784-797 | First Published: 21 February 2023

*Pharmacovigilance*
Real‐World Hepatic Safety of Oral Acetaminophen Versus Loxoprofen/Celecoxib: Using a Nationwide Electronic Medical Record Database
Yasuyuki Okumura PhD, Takeshi Kimura MD, PhD, Shoichiro Inokuchi MD, PhD, Masahiro Okamoto PhD, Toshio Takano MT, Masumi Miyake , Yuji Kumagai MD, PhD
Pages: 798-806 | First Published: 26 February 2023

*Special Populations*
Pharmacokinetics and Safety of Imeglimin in Japanese Patients With Impaired Renal Function
Atsushi Kitamura MS, Takuya Yumizaki BS, Tomoe Kondo BS, Hisakuni Sekino MD, PhD, Hiroyoshi Kakuyama PhD
Pages: 807-816 | First Published: 27 February 2023

*Pharmacometrics*
Population Pharmacokinetics of Monalizumab in Patients With Advanced Solid Tumors
Michael Hwang PharmD, Chunling Fan PhD, Mun Sang Yue PhD, Diansong Zhou PhD, Carine Paturel PhD, Pascale Andre PhD, Lin-Yang Cheng PhD, Patrick Mitchell PhD, Panagiotis Kourtesis PhD, Dario Ruscica MD, Mayukh Das MD, Nassim Morsli MD, Song Ren PhD, Megan Gibbs PhD, Alex Phipps PhD, Xuyang Song PhD, MBA
Pages: 817-829 | First Published: 28 February 2023

Population Pharmacokinetics of Anlotinib, a Multiple Receptor Tyrosine Kinase Inhibitor, in Chinese Patients With Malignant Tumors
Gaoqi Xu MD, Dihong Yang MD, Qi Shu MD, Junfeng Zhu PhD, Haiying Ding MD, Wenxiu Xin PhD, Like Zhong MD, Liqin Zhu PhD, Luo Fang PhD
Pages: 830-837 | First Published: 05 April 2023

*Pharmacokinetics*
Effect of Roux‐En‐Y Gastric Bypass in the Pharmacokinetics of (R)‐Carvedilol and (S)‐Carvedilol
Priscila Akemi Yamamoto MSc, Rodrigo Cristofoletti PhD, Valvanera Vozmediano PhD, Cristiane Masetto de Gaitani PhD, Rodrigo Moreira da Silva PhD, Rafael Kemp PhD, Ajith Kumar Sankarankutty PhD, Wilson Salgado Junior PhD, Jose Sebastião dos Santos PhD, Natalia Valadares de Moraes PhD
Pages: 838-847 | First Published: 28 February 2023

*Physiologically Based Pharmacokinetic Modeling*
Physiologically Based Pharmacokinetic Modeling Characterizes the Drug‐Drug Interaction Between Saxagliptin and Rifampicin in Patients With Renal Impairment
Wanhong Wu MS, Rongfang Lin MS, Meng Ke MS, Lingling Ye MS, Cuihong Lin PhD
Pages: 848-858 | First Published: 03 March 2023

*Editor's Choice: Pediatric Pharmacology*
Use of Clinical Trial Simulations to Compare the Performance of Different Approaches for Population Analyses of Pediatric Pharmacokinetic Data
Zaid Temrikar PhD, Elena Muensterman PhD, Benjamin Engelhardt PhD, Mohamed-Eslam F. Mohamed RPh, PhD, FCP
Pages: 859-868 | First Published: 11 March 2023

🔥 Early Bird registration ends in 48 HOURS on June 30th for the Annual Meeting, Sept 10 - 12, 2023. We encourage you to register today to secure your spot at this outstanding rate. >> https://bit.ly/3NghRPS

We look forward to seeing you in Bellevue, WA!

➡️ It's not too late to register for the Trends in Drug Development Seminar on Sept 9th from 8:00 AM to 5:30 PM PT during the Annual Meeting.

This Seminar will cover the following topics:
- Opioid Crisis in the US: A Complex Problem Requires an Innovative Approach

- Leveraging mRNA Technology for Vaccine & Therapeutics: Let's Expand the Clinical Pharmacology Paradigm

- A Quest for Aging Well: Addressing Drug Development & Safety in the US Older Adult Population

- AI in Drug Development Part I: Preclinical & Clinical

Do not miss this opportunity to connect with experts in the field and gain practical insights that are directly applicable to the drug development process.

The discounted Early Bird rate ends June 30th so we encourage you to register today! For the full agenda please visit >> https://bit.ly/3Nc5zaf

❗ Early Bird registration ends in ONE WEEK on June 30th!

Register now for the best rates >> https://bit.ly/3NghRPS

And be sure to invite your colleagues to the Annual Meeting, Sept 10 - 12, 2023, for three days of exceptional, cutting-edge, clinical pharmacology-focused sessions.

We look forward to seeing you in September!

The US issued a discussion paper entitled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products.” It is intended to facilitate discussions with stakeholders on the use of artificial intelligence and machine learning in drug development to help inform the regulatory landscape in this area.

For more information, please visit >> https://bit.ly/3CwCEL1

Artificial Intelligence and Machine Learning for Drug Development Computer science, statistics & engineering uses algorithms/models to perform tasks & exhibit behaviors such as learning, making decisions, and making prediction

📣 Early Bird registration ends in TWO WEEKS on June 30th!

Don't miss this opportunity to join your colleagues in person at the Annual Meeting for three days of exceptional, cutting-edge, clinical pharmacology-focused sessions.

We encourage you to register now for the best rates >> https://bit.ly/3NghRPS

Be sure to invite your colleagues.

We look forward to seeing you at the Hyatt Regency Bellevue in September!

The US approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

For full prescribing information, please visit >> https://bit.ly/3X2WVkS

www.accessdata.fda.gov

ACCP will host the Trends in Drug Development Seminar on Sept 9th from 8:00 AM to 5:30 PM PT.

Do not miss this opportunity to connect with experts in the field and gain practical insights that are directly applicable to the drug development process.

Make the most of your time at the Annual Meeting by adding the Trends in Drug Development Seminar to your agenda.

Space is limited and a separate registration fee is required. https://bit.ly/3zqWlCw

Clinical Pharmacology in Drug Development, June 2023 Volume 12, Issue 6 is now available!
https://bit.ly/3qBS5z5


Articles
Disposition and Mass Balance of Etrasimod in Healthy Subjects and In Vitro Determination of the Enzymes Responsible for Its Oxidative Metabolism
Caroline A. Lee, D. Alexander Oh, Yong Tang, Ping Yi, Mohammad Bashir, Stephen English, Marie Croft, Anthony Blackburn, Steve Bloom, Kye Gilder, John S. Grundy
Pages: 553-571 | First Published: 03 May 2023

Pharmacokinetics and Bioequivalence of Fluconazole Capsules Manufactured in France and China in Healthy Chinese Participants: Open‐Label, Randomized, Single‐Dose, 2‐Way, Crossover Bioequivalence Study Under Fasted and Fed Conditions
Naihan Chen, Qing He, Ying Ma, Shixue Liu, Hua Wei, Ao Peng
Pages: 572-578 | First Published: 10 April 2023

Phase 1 Clinical Trial of PPMX‐T003, a Novel Human Monoclonal Antibody Specific for Transferrin Receptor 1, to Evaluate Its Safety, Pharmacokinetics, and Pharmacodynamics
Yoichiro Ogama, Yuji Kumagai, Norio Komatsu, Marito Araki, Nami Masubuchi, Hiroko Akiyoshi, Tadashi Matsuura, Hiromi Kirisako, Akiko Kyoya, Fumiko Nomura, Yuta Ohira, Takuya Yokokawa, Yukiya Yamamoto
Pages: 579-587 | First Published: 30 December 2022

Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Formulations of 0.2‐g Ibuprofen Granules
Jianfen Su, Canhua Zhang, Yue Su, Chen Huang, Jinlong Zhao, Hui Yang, Zuoheng Xu, Jianhao Li, Xinchun Yang
Pages: 588-593 | First Published: 28 December 2022

Pharmacokinetics and Safety of Single and Multiple Daily Dosing of 75‐mg Rimegepant Orally Disintegrating Tablets in Healthy Chinese Adults: A Randomized Placebo‐Controlled Trial
Yan Li, Xinghe Wang, Alex Ballesteros-Perez, Richard Bertz, Zhihong Lu
Pages: 594-601 | First Published: 20 February 2023

Pharmacokinetics, Safety, and Bioequivalence of 2 Lopinavir/Ritonavir (200/50 mg) Tablets in Healthy Chinese Volunteers: Effect of Food on Absorption
Wei Zhang, Lili Lin, Wanjin Fu, Dandan Bao, Qian Zhang, Yueyue Liu, Liang Zheng, Wei Hu
Pages: 602-610 | First Published: 15 February 2023

A Phase 1 First‐in‐Human Pharmacokinetic and Pharmacodynamic Study of JNJ‐64264681, a Covalent Inhibitor of Bruton's Tyrosine Kinase
Jocelyn H. Leu, Xin Miao, Kevin Shalayda, Kevin J. Coe, Ariane Kahnt, Bonnie Wu, Megan Schnarr, Carol Franks, James Devlin, Tong-Yuan Yang, James A. Palmer, Mai Zhang, Honghui Zhou, Wim Van Damme, Sophie Smets, Zuleima Aguilar, Sandra R. Chaplan
Pages: 611-624 | First Published: 01 May 2023

A Phase 1 First‐in‐Human Single‐Ascending‐Dose Trial With ESB1609, a Selective Agonist to the Sphingosine‐1‐Phosphate Receptor 5
Nicholas P. France, Christopher Rubino, M. Courtney Safir, Mari Maurer, Tram Duong, Deepika Singamsetty, Khalid Abd-Elaziz, Thomas Chou, Sethu Sankaranarayanan, Marieke Ettema, Rebecca Cosford, Peter Dogterom, Enchi Liu, Carrolee Barlow
Pages: 625-638 | First Published: 16 May 2023

Effect of Dietary Intake on the Pharmacokinetics of the Multitargeted Receptor Tyrosine Kinase Inhibitor Famitinib: Results From a Phase 1 Study in Healthy Chinese Participants
Xiaoran Zhang, Gexin Shi, Shaorong Li, Jing Rao, Qing Wen, Hengli Zhao
Pages: 639-644 | First Published: 03 March 2023

Pharmacokinetics and Safety Evaluation of Maribavir in Healthy Japanese and Matched White Participants: A Phase 1, Open‐Label Study
Ivy Song, Ben Suttle, Jingyang Wu, Katarina Ilic
Pages: 645-654 | First Published: 10 April 2023

The US approved QALSODY (tofersen) for the treatment of (ALS) in adults who have a mutation in the 1 (SOD1) gene.

For full prescribing information, please visit >> https://bit.ly/42voiFv

www.accessdata.fda.gov

The announced the availability of a final guidance for industry entitled "Clinical Drug Interactions Studies with Combined Oral Contraceptives", replacing the November 2020 draft guidance.

Please refer to the final guidance for more details.
https://bit.ly/3oXmk2P

Clinical Drug Interaction Studies With Combined Oral Contraceptives Clinical Pharmacology

July 31st is the deadline to submit your Proposal for the Annual Meeting, "Transformative Solutions: Delivering on the Promise of Clinical Pharmacology for Patient Care", Sept 8 – 10, 2024 in Bethesda, MD!

To learn more about the Areas of Submission & Guidelines visit: https://bit.ly/2V5VgMZ

We look forward to receiving your Proposal and encourage you to invite your colleagues to submit a Proposal.

The Journal of Clinical Pharmacology - June 2023, Vol 63, Issue 6 is now available! https://bit.ly/3P12oa5

*In Memoriam*
In Memoriam
Gerald Yakatan BS, MS, PhD, FCP
Pages: 639 | First Published: 03 March 2023

*Continuing Education: Review*
Do ADHD Treatments Improve Executive Behavior Beyond Core ADHD Symptoms in Adults? Evidence From Systematic Analysis of Clinical Trials
Craig B.H. Surman MD, Daniel M. Walsh BA
Pages: 640-653 | First Published: 02 February 2023

*Therapeutics*
Comparison of the Treatment Persistence Among 4 Direct Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation: A 5‐Year Retrospective Cohort Study
Tomohiro Aigami BS, Tomoyuki Ishigo BS, Ryo Takada BS, Toshiyuki Yano MD, PhD, Masayuki Koyama MD, PhD, Satoshi Katano PhD, Satoshi Fujii PhD, Masahide Fukudo PhD
Pages: 654-663 | First Published: 07 January 2023

Low Early Antifactor Xa Target Achievement Rate of Low‐Molecular‐Weight Heparin for Treating Venous Thromboembolism in Patients in Intensive Care
Li Zhang PhD, Lei Zhang MD, Ping Li MD, Chenwei Liu MM, Qiwen Zheng MM, Yan Wang PhD
Pages: 664-671 | First Published: 05 February 2023

*Pharmacometrics*
In Silico Re‐Optimization of Atezolizumab Dosing Using Population Pharmacokinetic Simulation and Exposure–Response Simulation
Cody J. Peer MS, PhD, Keith T. Schmidt PharmD, PhD, Oluwatobi Arisa PhD, William J. Richardson BS, Koosha Paydary MD, Daniel A. Goldstein MD, James L. Gulley MD, PhD, William D. Figg PharmD, FCP, Mark J. Ratain MD, FCP
Pages: 672-680 | First Published: 09 January 2023

Population Pharmacokinetics as a Tool to Reevaluate the Complex Disposition of Ethanol in the Fed and Fasted States
Sören Büsker, Alan Wayne Jones PhD, Robert G. Hahn MD, PhD, Max Taubert MD, Ulrich Klotz PhD, Matthias Schwab MD, Uwe Fuhr MD
Pages: 681-694 | First Published: 23 January 2023

*Editor's Choice: Regulatory Science*
US FDA Postmarketing Requirements and Commitments: A Systematic Assessment of Clinical Pharmacology Studies and Their Impact on US FDA Prescribing Information
Sarah Ridge PhD, Daphne Guinn PhD, Elimika Pfuma Fletcher PharmD, PhD, Issam Zineh PharmD, MPH, Rajanikanth Madabushi PhD, Anuradha Ramamoorthy PhD, FCP
Pages: 695-703 | First Published: 02 February 2023

*Pharmacokinetics/Pharmacodynamics*
Population Pharmacokinetics, Exposure–Safety, and Probability of Target Attainment Analyses for Isavuconazole in Japanese Patients With Deep‐Seated Mycoses
Shinichiro Shirae MS, Yuri Tsuruya MS, Tomohito Kozaki MS, Junnosuke Mizuhata BS, Atsushi Ose PhD
Pages: 704-714 | First Published: 13 February 2023

*Pediatric Pharmacology*
Effectiveness of Sufentanil‐Based Patient‐Controlled Analgesia Regimen in Children and Incidence of Adverse Events Following Major Congenital Structure Repairs
Deying Xie MM, Fei Liu MD, Yunxia Zuo MD
Pages: 715-720 | First Published: 10 February 2023

Population Pharmacokinetics and Exposure‐Response Modeling Analyses of Golimumab in Children and Young Adults With Recently Diagnosed Type 1 Diabetes
Jong B**g Lee PhD, Wangda Zhou PhD, Zhenhua Xu MD, PhD, FCP, Joseph A. Hedrick PhD, Jocelyn H. Leu PharmD, PhD
Pages: 721-731 | First Published: 28 February 2023

*Special Populations*
Pharmacokinetics of JNJ‐73763989 and JNJ‐56136379 (Bersacapavir) in Participants With Moderate Hepatic Impairment
Thomas N. Kakuda PharmD, Atef Halabi MD, PhD, Gernot Klein MD, Madhu Sanga PhD, Carine Guinard-Azadian MD, Monika Kowalik MD, Katja Nedoschinsky, Julius Nangosyah MS, Emmanuel Njumbe Ediage PharmD, Vera Hillewaert MS, Peter Verboven BS, Ivo Goris, Jan Snoeys PhD, Martyn Palmer MBA, Michael Biermer MD
Pages: 732-741 | First Published: 14 February 2023

*Letters to the Editor*
Stevens–Johnson Syndrome in an Adult Filipino Male Positive for HLA‐B*38:16 and B*58:17, Associated With Allopurinol: A Case Report
Ana Rouselle Reyes-Ramos MD, Ivan Arni C. Preclaro MD, Michelle Marie S. Castillo MD, Sarah Elizabeth S. Basco MD
Pages: 742-744 | First Published: 15 February 2023

Revisiting Old Drugs Owing to the Glymphatic System: A Step Toward Unlocking the Role of Hypnotics in Brain Health
Einstein Francisco Camargos MD, PhD, Otávio Toledo Nóbrega PhD
Pages: 745-746 | First Published: 03 March 2023

*Corrections*
Correction
Pages: 747 | First Published: 07 April 2023

The announced the availability of final guidance for industry entitled "Drug-Drug Interaction Assessment for Therapeutic Proteins", replacing the Aug 2020 draft guidance.

Please refer to the final guidance for more info. https://bit.ly/3WU4iLl

Drug-Drug Interaction Assessment for Therapeutic Proteins Clinical Pharmacology

❗ Early Bird registration ends June 30th for the Annual Meeting, "Revolutionizing Clinical Pharmacology: Meeting the Challenge & Leading the Way". Don't miss this opportunity to join your colleagues in person for three days of exceptional, cutting-edge, clinical pharmacology-focused sessions.

We encourage you to register now for the best rates >> https://bit.ly/3NghRPS

The 3-day registration includes the PharmaFete social celebrating the start of the meeting, Evening Receptions and Poster Sessions, Lunch & Awards events and networking with your colleagues.

We look forward to seeing you in Bellevue, WA!

The US approved ZYNYZ (retifanlimab-dlwr) for the treatment of adult patients with or recurrent locally advanced Merkel cell .

For detailed prescribing information, please visit >> https://bit.ly/425MTk2

www.accessdata.fda.gov

Your job search doesn't need to be puzzling. New job opportunities are posted daily and are available for every career level on the . http://bit.ly/2J0TTKj

Congratulations Drs. Abdallah and Anderson and Mr. Crosby on becoming an ACCP Fellow! We look forward to your continued contribution to the society.

❗ Don't miss this opportunity to Exhibit or Sponsor at the Annual Meeting!

Exhibitors have direct access to decision-makers throughout the meeting where you can foster meaningful conversations that could lead to business opportunities.

Sponsorship opportunities are available to maximize your exposure and align with your goals.

Take this opportunity and Secure your Sponsorship or Exhibit space today for the Annual Meeting!

For more information on Exhibit and Sponsorship opportunities, please visit >> https://bit.ly/43bcfh5

➡️ Tomorrow is the May 2023 ACCP Clinical Practice Webinar: Leveraging Novel Microbiome-related Therapies.

May 24, 2023 | 2:00 PM ET

Don't miss the opportunity to join the Faculty Speakers as they present preliminary gut microbiome data investigating the gut microbiome of abstinent and currently drinking individuals with alcohol use disorder.

There's still time to register for free and secure your seat. https://bit.ly/3Aoh0aL

ACCP will host a Pre-meeting Workshop on A Snapshot of Clinical Pharmacology Workflows With R on Sept 9, 2023 you will not want to miss.

This Pre-meeting Workshop will be useful for beginner to intermediate-level R users and can range from doctorate-level students (MD, PharmD, PhD) to postdoctoral fellows and early-stage professionals with an interest in enhancing their skills in applying state-of-the-art data and pharmacometrics analysis methods in drug development and patient care.

Make the most of your time at the Annual Meeting by adding the Pre-meeting Workshop to your agenda. (separate registration fee required)

Register today, space is limited! https://bit.ly/3zqWlCw

The published final guidance for industry "Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications". This guidance describes the FDA’s thinking regarding: (1) when clinical drug-drug interactions with acid-reducing agents are recommended; (2) the design of such clinical drug-drug interaction studies; (3) how to interpret the study results; and (4) communicating findings in drug product labeling.

For more info, please visit >> https://bit.ly/3lhN6RE

Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducin Clinical Pharmacology Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry

🔥 {It's Not Too Late} Tomorrow is the ACCP Virtual Journal Club Webinar: Model-Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases

May 17, 2023 | 2:00 - 3:00 PM ET
Registration is free!

Register today to secure your seat >> https://bit.ly/41ghQSM

We look forward to seeing you tomorrow!

The OCP, OTS, CDER at the US is excited to announce the availability of a fellowship in maternal clinical pharmacology.

Applications will be reviewed on a rolling basis with a final deadline of June 30, 2023, 3:00 ET.

For more info, please visit >> https://bit.ly/3o3tTo7

Zintellect - Climb Higher Connect with ORISE...on the GO!  Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!

The US Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research and the Duke-Margolis Center for Health Policy will host a jointly sponsored virtual public workshop on the Rare Disease Endpoint Advancement (RDEA) Pilot Program and novel endpoint development for rare disease drug development.

For more information on this workshop, visit >> https://bit.ly/42ZfpES

FDA CDER and CBER & Duke-Margolis Center for Health Policy The purpose of this public workshop is to discuss topics relevant to the development of endpoints for rare diseases.

The US Small Business & Industry Assistance will hold a one-hour webinar entitled "Overview: Clinical Pharmacology Considerations for Food Effect Studies."

For more info on this webinar, please visit > https://bit.ly/3VXd2zS

Overview: Clinical Pharmacology Considerations for Food Effect Studies Clinical Pharmacology Considerations for Food Effect Studies: An Overview of the FDA Food Effect Guidance

ACCP is happy to announce Cynthia J. (CJ) Musante, PhD, Vice President of Scientific Research and the Global Head of Quantitative Systems Pharmacology (QSP), Clinical Pharmacology & Bioanalytics, at Pfizer Inc as the Annual Meeting Invited Keynote!

She will present "AI in Clinical Pharmacology". Register today...https://bit.ly/3zqWlCw

✔️ REMINDER...Register today for the May 2023 ACCP Clinical Practice Webinar: Leveraging Novel Microbiome-related Therapies

May 24, 2023 | 2:00 - 3:30 PM ET
Registration is free!

Join Drs. Jennifer Barb and Lorenzo Leggio as they discuss preliminary gut microbiome data investigating the gut microbiome of abstinent and currently drinking individuals with alcohol use disorder (AUD) and controls.

Secure your seat today >> https://bit.ly/3Aoh0aL

The US approved REZZAYO for patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.

Approval of this indication is based on limited clinical safety and efficacy data for REZZAYO.

For prescribing information, please visit >> https://bit.ly/3nISA9t

www.accessdata.fda.gov

Clinical Pharmacology in Drug Development, May 2023 Volume 12, Issue 5 is now available!
https://bit.ly/3LHmhzx


Articles
Exposure–response Modeling From the CLARITY Trial of Pimavanserin for Adjunctive Treatment of Major Depressive Disorder
Mona Darwish, Bryan Dirks, Julie Passarell, David Jaworowicz, Sebastien Bihorel, Becky Howell, Joel Owen, Daryl DeKarske, Srdjan Stankovic
Pages: 463-474 | First Published: 07 March 2023

Dosing Recommendation Based on the Effects of Different Meal Types on Pexidartinib Pharmacokinetics in Healthy Subjects: Implementation of Model‐informed Drug Development Strategy
Hamim Zahir, Ophelia Yin, Ching Hsu, Andrew J. Wagner, Jason Jiang, Xiaoning Wang, Jon Greenberg, Dale E. Shuster, Tarundeep Kakkar, Frank LaCreta
Pages: 475-483 | First Published: 21 March 2023

Relative Bioavailability and Food Effect of Asciminib Pediatric Mini‐tablet Formulation Compared to the Reference Tablet Formulation in Healthy Adult Participants
Matthias Hoch, Lidiya Bebrevska, Namrata Singh, Florence Hourcade-Potelleret
Pages: 484-492 | First Published: 09 January 2023

The Oral Bioavailability and Effect of Various Gastric Conditions on the Pharmacokinetics of Dersimelagon in Healthy Adult Volunteers
Kei Ogawa, Ryosuke Ide, Kirstine Belongie, Minoru Tsuda, Hiroki Kawanishi, Renli Teng, Akihito Ogasawara
Pages: 493-501 | First Published: 25 February 2023

Comparative Bioavailability of a Novel Solution and a Tablet Formulation of Levothyroxine
Sunil Vandse, Yannis Psarrakis, Kris Washington, Michelle A. Baron
Pages: 502-508 | First Published: 06 March 2023

Pharmacokinetic and Bioequivalence Studies of 2 Metformin Glibenclamide Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions
Xiaolun Huang, Jiao Huang, Xinjing Li, Lin Chen
Pages: 509-517 | First Published: 15 January 2023

Biosimilarity Assessment of the Biosimilar Teriparatide Candidate and the Reference Drug in Healthy Subjects
Xuan Wang, Xintong Liang, Tenghua Wang, Yaoxuan Zhan, Haiyan Liu, Chen Li, Xianbo Li, Hui Ma, Zhiqin Hu, Xiaole Wang, Shuangshuang Xiao, Li Ban, Jin He, Yongmei Li, Yi Fang
Pages: 518-524 | First Published: 29 January 2023

Safety, Tolerability, and Pharmacokinetics of IMU‐935, a Novel Inverse Agonist of Retinoic Acid Receptor–Related Orphan Nuclear Receptor γt: Results From a Double‐Blind, Placebo‐Controlled, First‐in‐Human Phase 1 Study
Thomas M. Polasek, Indika Leelasena, Irina Betscheider, Marija Marolt, Hella Kohlhof, Daniel Vitt, Frank Fliegert, Andreas R. Muehler
Pages: 525-534 | First Published: 20 March 2023

Effect of Multiple Doses of Sparsentan on the Single‐Dose Pharmacokinetics of Dapagliflozin: An Open‐Label Drug–Drug Interaction Study in Healthy Adults
Shang-Chiung Chen, Danlin Cai, Claire Winnett, Mai Nguyen, Neeraj Verma, Kai Liu, Priscila Preciado
Pages: 535-541 | First Published: 28 February 2023

Evaluation of Pharmacokinetics and Safety With Bioequivalence of Voriconazole Injection of 2 Formulations in Chinese Healthy Volunteers: Bioequivalence Study
Chunqi Huang, Danqing D**g, Fei Yu, Xueying Ren, Yi Wu, Zhuoyan Wang, Ying Wang
Pages: 542-547 | First Published: 13 February 2023