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Contains 5 Component(s), Includes Credits
Learners that complete this webinar will gain knowledge about a First-in-Class drug with a novel mechanism of action. SP-624 (generic name forvisirvat) is a small molecule activator of the sirtuin (SIRT) 6 enzyme. SIRT6 is a NAD+ dependent histone deacetylase and is believed to be the first activator of the enzyme tested in human clinical trials. It is currently being assessed in a Phase 2b/3 study for the treatment of major depressive disorder. The webinar presents data from single ascending dose and multiple ascending dose studies conducted in healthy male and female subjects. The safety, tolerability and pharmacokinetics after single multiple doses of forvisirvat will be reviewed.
2025 ACCP Virtual Journal Club Webinar: Safety, Tolerability & Pharmacokinetics of Oral Doses of the Sirtuin 6 Activator SP-624 - ON DEMAND
Live Session: Tuesday, March 18th, 2025, from 12:00 to 1:00 PM ET
On Demand: March 18th, 2025 to March 18th, 2028
Why is this webinar important to your practice?
Learners that complete this webinar will gain knowledge about a First-in-Class drug with a novel mechanism of action. SP-624 (generic name forvisirvat) is a small molecule activator of the sirtuin (SIRT) 6 enzyme. SIRT6 is a NAD+ dependent histone deacetylase and is believed to be the first activator of the enzyme tested in human clinical trials. It is currently being assessed in a Phase 2b/3 study for the treatment of major depressive disorder. The webinar presents data from single ascending dose and multiple ascending dose studies conducted in healthy male and female subjects. The safety, tolerability and pharmacokinetics after single multiple doses of forvisirvat will be reviewed.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs and other health care professionals, including Clinical Pharmacologists and Allied Health Services, who are involved or interested in the dosing of Sirtuin 6 Activator SP-624.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the pharmacokinetics of SP-62;
- Identify key characteristics of dose estimation via ascending dose response of Sirtuin 6 Activator;
- Describe the safety assessments based on the adverse events, serious adverse events and treatment emergent adverse events (TEAEs) of Sirtuin 6 Activator;
- Discuss the use of pharmacokinetics in early drug development.
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Contains 12 Component(s), Includes Credits
The American College of Clinical Pharmacology® monthly journal article continuing education offerings from The Journal of Clinical Pharmacology.
Registration and Pricing
The American College of Clinical Pharmacology® (ACCP) offers a monthly article from the The Journal of Clinical Pharmacology (JCP) for continuing education credit. See the CE Info tab for more information on credits. The ACCP JCP Journal CE articles are priced and packaged for January through December of the same calendar year. Packages are available at no cost to ACCP Members and $75/calendar year to Non-members. Once registered, learners have access to all of the Journal CE articles for the calendar year as the articles are released.
To register, log into your ACCP online profile and then register by clicking the green Register button at the top right. Follow the online prompts to complete the registration process and to receive your registration confirmation. If you do not have an ACCP profile, one must be created before you can register for the Journal CE articles. If you do not know if you have a profile, please contact INFO@ACCP1.org for further information to avoid creating duplicate profiles. Please address all other questions to CE@ACCP1.org.
Requirements for Credits
All requirements for claiming CE credits are listed in the CE Info (Handout) tab. Continuing education credits and certificates must be claimed within 30-days of completing the monthly article offering. Continuing Pharmacy Education (CPE) data is uploaded into the CPE Monitor at the end of each month. The pharmacist's NABP# and MMDD of birth must be updated in their ACCP Profile or emailed to CE@ACCP1.org in order to have CPE credits uploaded to the CPE Monitor.
CE Expiration 12/31/2028
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Contains 1 Component(s)
Position Yourself for Success by Perfecting Your Clinical Pharmacology Skillset - ON DEMAND WEBINAR
2025 ACCP STEP & ESP Webinar: Position Yourself for Success by Perfecting Your Clinical Pharmacology Skillset
Live webinar: February 26, 2025 from 1:00 - 2:30 PM ET
On-demand webinar recording: February 26, 2025 to February 26, 2028
Target audience:
Student, Trainee & Early-stage Professional colleagues defining their career paths or considering a change in careers that may require an assessment of their skillset.
Objectives
After completing this activity, the learner will be able to:
1. Identify specific skill sets essential to your career path;
2. Navigate resources to supplement current experiences;
3. Strategize on building a professional and mentoring network;
4. Adopt a lifelong learning mindset to stay current in the field.
Description:
Student, Trainee & Early-stage Professional colleagues defining their career paths or considering a change in careers will benefit from this webinar that elucidates the skills required across the spectrum of academic, industry, clinical, regulatory or consulting careers. Hear from established experts in the field as they share their experiences and knowledge as leaders in the field and hiring managers about what skills are desirable to achieve not only your next position but long-term success. Panel discussions will be followed by a Question & Answer period.
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Contains 48 Component(s), Includes Credits
The American College of Clinical Pharmacology® monthly journal article continuing education offerings from The Journal of Clinical Pharmacology.
Registration and Pricing
The American College of Clinical Pharmacology® (ACCP) offers a monthly article from the The Journal of Clinical Pharmacology (JCP) for continuing education credit. See the CE Info tab for more information on credits. The ACCP JCP Journal CE articles are priced and packaged for January through December of the same calendar year. Packages are available at no cost to ACCP Members and $75/calendar year to Non-members. Once registered, learners have access to all of the Journal CE articles for the calendar year as the articles are released.
To register, log into your ACCP online profile and then register by clicking the green Register button at the top right. Follow the online prompts to complete the registration process and to receive your registration confirmation. If you do not have an ACCP profile, one must be created before you can register for the Journal CE articles. If you do not know if you have a profile, please contact INFO@ACCP1.org for further information to avoid creating duplicate profiles. Please address all other questions to CE@ACCP1.org.
Requirements for Credits
All requirements for claiming CE credits are listed in the CE Info (Handout) tab. Continuing education credits and certificates must be claimed within 30-days of completing the monthly article offering. Continuing Pharmacy Education (CPE) data is uploaded into the CPE Monitor at the end of each month. The pharmacist's NABP# and MMDD of birth must be updated in their ACCP Profile or emailed to CE@ACCP1.org in order to have CPE credits uploaded to the CPE Monitor.
CE Expiration 12/31/2027
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Contains 5 Component(s), Includes Credits
This presentation incorporates the use of Model-Informed Drug Development (MIDD) approaches to address the unique challenges in drug development and regulatory decision-making for patients with obesity. Given the high prevalence of obesity in the general population, it is essential to identify appropriate drug development strategies with optimal dosing for this patient group. However, the unique physiological and pathological characteristics of the obese population may present hurdles in clinical development programs. This presentation will provide an overview of the impact of obesity on pharmacokinetics, pharmacodynamics and the efficacy of drugs and, more importantly, demonstrate how MIDD approaches are applied at various stages of drug development and regulatory review for patients with obesity, with a focus on dosing regimen optimization, through case studies from recent submissions.
2024 ACCP Virtual Journal Club Webinar: Model-Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective - On Demand
Live Session: Wednesday, October 30th, 2024, from 1:00 to 2:00 PM ET
On Demand: October 30th, 2024 to October 30th, 2027
Why is this webinar important to your practice?
This presentation incorporates the use of Model-Informed Drug Development (MIDD) approaches to address the unique challenges in drug development and regulatory decision-making for patients with obesity. Given the high prevalence of obesity in the general population, it is essential to identify appropriate drug development strategies with optimal dosing for this patient group. However, the unique physiological and pathological characteristics of the obese population may present hurdles in clinical development programs. This presentation will provide an overview of the impact of obesity on pharmacokinetics, pharmacodynamics and the efficacy of drugs and, more importantly, demonstrate how MIDD approaches are applied at various stages of drug development and regulatory review for patients with obesity, with a focus on dosing regimen optimization, through case studies from recent submissions.
Target Audience:
Interprofessional team of MDs, PhDs, PharmDs and other health care professionals, including students, trainees and professionals at all levels, who are involved or interested in drug development for patients with obesity.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the impact of obesity on drug pharmacokinetics, pharmacodynamics and efficacy;
- Identify the unique challenges and opportunities in drug development for patients with obesity;
- Recognize the utility of model-informed drug development in facilitating clinical trial design and regulatory decision-making in patients with obesity.
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Contains 2 Component(s)
Clinical Pharmacology Considerations for ADCs & Bispecific Antibodies - ON DEMAND
2024 ACCP STEP & ESP Webinar: Clinical Pharmacology Considerations for ADCs & Bispecific Antibodies
Live webinar: October 2, 2024 from 12:00 - 1:00 PM ET
On-demand webinar recording: October 2, 2024 to October 2, 2027
Target audience:
Interprofessional team of MDs, PhDs, PharmDs including Students, Trainees and all levels of professionals seeking an introduction the biological principles and clinical pharmacology considerations for antibody-drug conjugates and bispecific antibodies.
Learning Objectives
After completing this activity, the learner will be able to:
1. Understand the mechanism of actions of ADCs and bispecific antibodies;
2. Apply clinical pharmacology principles in different stages of the development of novel therapeutics;
3. Leverage model-informed drug development approaches in the dose optimization of novel therapeutics;
4. Identify the opportunities and challenges for dose optimization trials.Description:
Attendees of all experience levels will receive a practical introduction to the exciting modalities of antibody-drug conjugates (ADCs) and bispecific antibodies. ADCs and bispecifics represent new frontiers in immunotherapy and are generating massive interest from prescribers and pharmaceutical companies alike. This webinar, presented by two experts in the spaces of ADCs and bispecifics, will provide a conceptual foundation of the two modalities and how they differ from traditional antibody therapeutics. In the meantime, ADCs and bispecifics also bring novel challenges in drug development. The clinical pharmacology considerations for evaluating the two modalities, including model-informed approaches and dose optimization, will be discussed and illustrated with case studies.
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Contains 5 Component(s), Includes Credits
This study explores innovative methods to predict body fat content using easily measurable anthropometric variables like age, height, weight and waist circumference instead of relying on the expensive and less accessible dual-energy x-ray absorptiometry (DXA) scanning. This research is crucial as it provides an improved and validated algorithm for predicting absolute body fat, which can enhance clinical practices related to obesity management. Understanding these new predictive methods can directly impact practice, especially considering the critical role that body composition plays in pharmacokinetics and pharmacodynamics. Efficient and accurate body fat estimation methods are essential for optimizing drug dosing and therapeutic strategies in obese patients, thereby improving treatment outcomes and patient care. Learners that complete this activity will be provided an evidence-based, validated and predictive algorithm as an alternative to DXA scanning to accurately estimate absolute body fat.
2024 ACCP Virtual Journal Club Webinar: Estimation of Absolute and Relative Body Fat Content Using Noninvasive Surrogates: Can DXA Be Bypassed?
Live Session: Wednesday, June 26th, 2024, from 12:00 to 1:00 PM ET
On Demand: June 26th, 2024 to June 26th, 2027
Why is this article important to your practice?
This study explores innovative methods to predict body fat content using easily measurable anthropometric variables like age, height, weight and waist circumference instead of relying on the expensive and less accessible dual-energy x-ray absorptiometry (DXA) scanning. This research is crucial as it provides an improved and validated algorithm for predicting absolute body fat, which can enhance clinical practices related to obesity management. Understanding these new predictive methods can directly impact practice, especially considering the critical role that body composition plays in pharmacokinetics and pharmacodynamics. Efficient and accurate body fat estimation methods are essential for optimizing drug dosing and therapeutic strategies in obese patients, thereby improving treatment outcomes and patient care. Learners that complete this activity will be provided an evidence-based, validated and predictive algorithm as an alternative to DXA scanning to accurately estimate absolute body fat.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs, Nurse Practitioners and other health care professionals who use the assessment of body fat content in clinical trials and clinical practice.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe at least one limitation to the use of DXA scanning for obesity clinical trials and/or drug development;
- Identify at least one DXA-determined measurement that was selected as a dependent (outcome) variable in this study;
- List at least one surrogate variable that was predictive of DXA-determined absolute body fat;
- Identify which surrogate variable had the greatest impact (i.e., magnitude of change) on DXA-determined total body fat in men and women utilizing standardized regression coefficient data.
David J. Greenblatt, MD
Professor
Tufts Univ School of Medicine
David J. Greenblatt, M.D.
Louis Lasagna Endowed Professor, Tufts University School of Medicine.
A native of Newton, Massachusetts, Dr. Greenblatt is a Magna Cum Laude graduate of Amherst College (1966). He graduated from Harvard Medical School in 1970, then trained in internal medicine at the Montefiore Hospital, New York City (1970-1971), and on the Harvard Medical Service at Boston City Hospital (1971-1972). Following a Fellowship in Clinical Pharmacology at Massachusetts General Hospital, under the mentorship of Dr. Jan Koch-Weser (1972-1974), he stayed on to head their Clinical Pharmacology Unit (1975-1979).
Dr. Greenblatt has been on the Faculty of Tufts University School of Medicine (TUSM) and the Staff of Tufts Medical Center (TMC) since 1979. He is a senior faculty member in the Graduate Program in Pharmacology & Drug Development, and has previously served as Chair of the Department of Pharmacology and Experimental Therapeutics at TUSM, Program Director and Associate Program Director of the institution’s Clinical/Translational Research Center, and Chair of the Institutional Review Board. He has received many awards and honors over his career, including the Distinguished Investigator Award from the American College of Clinical Pharmacology, and the Oscar B. Hunter Career Achievement Award from the American Society for Clinical Pharmacology and Therapeutics
There are no relevant financial relationships to disclose.
Joseph Ma, PharmD
Professor, Clinical Pharmacy
Univ of California San Diego, Skaggs School of Pharmacy & Pharmaceutical Sciences
Joseph D. Ma, PharmD, FCP is Professor in the Division of Clinical Pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences, Univ of California San Diego. He is also the faculty director of the Drug Development and Product Management Master’s Program at UC San Diego. He received his pharmacy degree from Univ of California San Francisco and completed a clinical pharmacology fellowship at Bassett Healthcare, Cooperstown, NY. His research interests are evaluating in vivo drug metabolizing enzyme activity in the context of drug-drug interactions and opioid pharmacokinetic variability. His current clinical practice is the Doris A. Howell Pain and Palliative Care Service at the Univ of California San Diego Moores Cancer Center. Under a collaborative practice agreement he is able to initiate, stop, and/or adjust therapy for the management of pain and other physical symptoms associated with cancer and/or chemotherapy.
There are no relevant financial relationships to disclose.
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Contains 2 Component(s)
Defining Your Journey: The Path to Professional Growth & Leadership-LIVE WEBINAR
2024 ACCP STEP & ESP Webinar: Defining Your Journey: The Path to Professional Growth & Leadership
Live webinar: June 13, 2024 from 1:00 - 2:30 PM ET
On-demand webinar recording: June 13, 2024 to June 13, 2027
Target Audience:
Student, Trainees & Early-stage Professionals interested in developing their leadership and professional growth as they transition into full-time careers.
Learning Objectives
After completing this activity, the learner will be able to:
1. Identify key elements of effective leadership styles;
2. Practice interpersonal skills to achieve effective communication;
3. Demonstrate how to inspire others to action to achieve common objectives;
4. Employ resources and prioritize time to achieve milestones toward the stated objectives.
Kacey Anderson
Director, Clinical Pharmacology
Terns Pharmaceuticals Inc
Kacey Anderson, PhD, is Director of Clinical Pharmacology at Terns Pharmaceuticals. Prior to Terns, Dr. Anderson was a Director of Clinical Pharmacology at EQRx International and prior to that she was at Gilead Sciences in clinical pharmacology. Dr. Anderson has worked on programs from early stage (IND filing and development plan) through approval, including being primary author on multiple m2.7.2’s in both US and ex-US submissions in inflammation and oncology disease areas. She has more than eight years of industry experience which includes designing and leading a variety of Phase 1 studies as well as supporting Phase 2 and Phase 3 studies. Dr. Anderson earned her PhD in Pharmaceutical Sciences from the University of Pittsburgh and holds a Bachelor of Science in Chemistry from St. Lawrence University. She is a Fellow of the American College of Clinical Pharmacology (ACCP) and has served on numerous committees and initiatives within ACCP.
Navin Goyal
Senior Director and Group Lead
Janssen Research & Development, LLC
Navin Goyal is a Senior Director and Therapy Area Lead in the Clinical Pharmacology and Pharmacometrics (CPP) Group at Janssen Pharmaceuticals, New Jersey. Dr. Goyal joined ACCP as a student in 2007, has been a Fellow since 2016, currently serves on the Board of Regents and is Treasurer for ACCP. He was the 2021 ACCP Annual Meeting Co-Chair. He has also chaired scientific symposia and presented at previous Annual Meetings.
Dr. Goyal graduated from the Department of Pharmaceutics in College of Pharmacy at University of Florida, Gainesville. After graduation, he worked in the Clinical Pharmacology, Modeling and Simulation group at GSK. At Janssen, Dr. Goyal is the CPP head of cardiovascular, metabolism, retinal, pulmonary hypertension and neuroscience therapy areas. In this role, he is responsible for applying quantitative clinical pharmacology principles and approaches across all phases of drug development spanning from early clinical studies through registration. He has published his research in clinical pharmacology and pharmacometrics across multiple therapy areas including respiratory, CNS, cardiovascular and infectious diseases. Apart from his day job, Dr. Goyal continues to mentor student interns, post-doctoral fellows and scientists within his group at Janssen and through external collaborations.
Zaid Temrikar
Clinical Pharmacologist
Gilead Sciences
Zaid Temrikar works as a clinical pharmacologist at Gilead Sciences supporting early and late stage assets within Immunology and Oncology portfolio in Foster City, CA. He completed his PhD from UTHSC in Memphis TN working on PK/PD of anti-infectives. He has held many leadership positions such as part of inaugural ACCP leadership cohort, student president of ISoP and president of AAPS student chapter. He has also been a part of ACCP STEP and ACCP Annual Meeting Program Committee.
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Contains 2 Component(s)
Defining Your Journey: The Path to Professional Growth & Leadership-LIVE WEBINAR
2024 ACCP STEP & ESP Webinar: Defining Your Journey: The Path to Professional Growth & Leadership
Live webinar: June 13, 2024 from 1:00 - 2:30 PM ET
On-demand webinar recording: June 13, 2024 to June 13, 2027
Target Audience:
Student, Trainees & Early-stage Professionals interested in developing their leadership and professional growth as they transition into full-time careers.
Learning Objectives
After completing this activity, the learner will be able to:
1. Identify key elements of effective leadership styles;
2. Practice interpersonal skills to achieve effective communication;
3. Demonstrate how to inspire others to action to achieve common objectives;
4. Employ resources and prioritize time to achieve milestones toward the stated objectives.
Kacey Anderson
Director, Clinical Pharmacology
Terns Pharmaceuticals Inc
Kacey Anderson, PhD, is Director of Clinical Pharmacology at Terns Pharmaceuticals. Prior to Terns, Dr. Anderson was a Director of Clinical Pharmacology at EQRx International and prior to that she was at Gilead Sciences in clinical pharmacology. Dr. Anderson has worked on programs from early stage (IND filing and development plan) through approval, including being primary author on multiple m2.7.2’s in both US and ex-US submissions in inflammation and oncology disease areas. She has more than eight years of industry experience which includes designing and leading a variety of Phase 1 studies as well as supporting Phase 2 and Phase 3 studies. Dr. Anderson earned her PhD in Pharmaceutical Sciences from the University of Pittsburgh and holds a Bachelor of Science in Chemistry from St. Lawrence University. She is a Fellow of the American College of Clinical Pharmacology (ACCP) and has served on numerous committees and initiatives within ACCP.
Navin Goyal
Senior Director and Group Lead
Janssen Research & Development, LLC
Navin Goyal is a Senior Director and Therapy Area Lead in the Clinical Pharmacology and Pharmacometrics (CPP) Group at Janssen Pharmaceuticals, New Jersey. Dr. Goyal joined ACCP as a student in 2007, has been a Fellow since 2016, currently serves on the Board of Regents and is Treasurer for ACCP. He was the 2021 ACCP Annual Meeting Co-Chair. He has also chaired scientific symposia and presented at previous Annual Meetings.
Dr. Goyal graduated from the Department of Pharmaceutics in College of Pharmacy at University of Florida, Gainesville. After graduation, he worked in the Clinical Pharmacology, Modeling and Simulation group at GSK. At Janssen, Dr. Goyal is the CPP head of cardiovascular, metabolism, retinal, pulmonary hypertension and neuroscience therapy areas. In this role, he is responsible for applying quantitative clinical pharmacology principles and approaches across all phases of drug development spanning from early clinical studies through registration. He has published his research in clinical pharmacology and pharmacometrics across multiple therapy areas including respiratory, CNS, cardiovascular and infectious diseases. Apart from his day job, Dr. Goyal continues to mentor student interns, post-doctoral fellows and scientists within his group at Janssen and through external collaborations.Zaid Temrikar
Clinical Pharmacologist
Gilead Sciences
Zaid Temrikar works as a clinical pharmacologist at Gilead Sciences supporting early and late stage assets within Immunology and Oncology portfolio in Foster City, CA. He completed his PhD from UTHSC in Memphis TN working on PK/PD of anti-infectives. He has held many leadership positions such as part of inaugural ACCP leadership cohort, student president of ISoP and president of AAPS student chapter. He has also been a part of ACCP STEP and ACCP Annual Meeting Program Committee.
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Contains 5 Component(s), Includes Credits
Edoxaban 60 mg is approved for stroke prevention in patients with atrial fibrillation (AF) not fulfilling any dose-reduction criteria. As edoxaban is partially renally cleared (≈50%), it was postulated that edoxaban exposure may be lower in patients with high creatinine clearance (CrCL >100 mL/min); thus, efficacy could hypothetically be lower in this subpopulation. In this webinar, the author will discuss a prospective, randomized, double-blinded study comparing the pharmacokinetics, pharmacodynamics, efficacy and safety outcomes of edoxaban 60 mg once daily versus edoxaban 75 mg once daily in patients with CrCL exceeding 100 mL/min. The presentation will also illustrate the utility of population PK modeling to account for variability and estimate steady-state PK values based on the sparse PK concentrations collected in the study.
2024 ACCP Virtual Journal Club Webinar: Edoxaban Exposure in Patients with Atrial Fibrillation and Estimated Creatinine Clearance Exceeding 100 mL/min - On Demand
Live Session: Wednesday, March 20th, 2024, from 2:00 to 3:00 PM ET
On Demand: March 20th, 2024 to March 20th, 2027
Why is this article important to your practice?
There is a lack of clear understanding of high creatinine clearance on pharmacokinetic/pharmacodynamic (PK/PD) outcomes. Edoxaban 60 mg is approved for stroke prevention in patients with atrial fibrillation (AF) not fulfilling any dose-reduction criteria. As edoxaban is partially renally cleared (≈50%), it was postulated that edoxaban exposure may be lower in patients with high creatinine clearance (CrCL >100 mL/min); thus, efficacy could hypothetically be lower in this subpopulation. In this webinar, the author will discuss a prospective, randomized, double-blinded study comparing the pharmacokinetics, pharmacodynamics, efficacy and safety outcomes of edoxaban 60 mg once daily versus edoxaban 75 mg once daily in patients with CrCL exceeding 100 mL/min. The presentation will also illustrate the utility of population PK modeling to account for variability and estimate steady-state PK values based on the sparse PK concentrations collected in the study.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs, and other health care professionals.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the impact of high creatinine clearance on edoxaban PK and PD and the potential clinical implications;
- Recognize the utility of population PK modeling in analyzing sparse PK concentrations collected from clinical studies;
- Describe the key elements of a prospective, randomized, placebo-controlled clinical trial.
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