Pharmacometrics Assessment Plan

October 31, 2024 • Uncategorized

Mission Statement

The mission of the program is to train healthcare professionals and researchers of health sciences in pharmacometrics to create solutions for a healthier community.

Mission Statement fulfills requirements of certificate accrediting organization:

Yes

Assessment Leader:

Tina Machu

Program Description:

The Certificate in Pharmacometrics is a 1-year program with 5 courses (total 15 credit hours) at The Health Science Center College of Pharmacy (HSCCP). The focus of the course work is to provide the students with foundational principles of PK-PD models, statistical considerations of pharmacometrics and software skills (e.g., R, NONMEM, Phoenix). First semester is designed to build the foundational principles of PK-PD models and modeling concepts using case studies.  Second semester will be used to understand the big picture of applications of pharmacometrics in drug development through case discussions.  The software skills needed for pharmacometrics analysis are taught in two pharmacometrics techniques courses. The courses are designed with various case studies that use active learning methods. The program is delivered fully online using state of the art technology.

Program Goal:

The goal of the Certificate in Pharmacometrics is to provide a skill-building program in quantitative tools that are used in drug development, regulatory decision-making, and precision dosing.

Accreditation:  SACSCOC

Assessment Responsibilities:

The program is overseen by an Academic Program Director (Dr. Tina Machu, Professor of Pharmaceutical Sciences in the HSC College of Pharmacy).  Dr. Machu coordinates the program and is responsible for assessment reporting and quality improvement.  Dr. Ayyappa Chaturvedula (Associate Professor of Pharmacotherapy in the HSC College of Pharmacy) is the pharmacometrics expert and is responsible for content of the certificate courses.

Program Outcomes

Assessment Methods

Student Learning Outcome 1

Students will be able to apply pharmacokinetic and pharmacodynamic models to solve drug development and precision dosing problems.

Is the outcome direct or indirect?

Direct

Description of Assessment

Performance in PHAR 7380, PHAR 7381, and PHAR 7382.  Course-embedded assignments in which students 1) use statistical software to understand and evaluate various pharmacokinetic (PK) and pharmacodynamic (PD) models and their assumptions in drug development research 2) use statistical principles related to PK and PD modeling and simulation activities and 3) critically assess various applications of pharmacometrics in conducting clinical pharmacology studies in drug development.

Criteria for Achievement

80% of the class with a grade of B or above in courses PHAR 7380, PHAR 7381, and PHAR 7382

Time Table

End of each course

Responsible Individuals

Dr. Tina Machu and Dr. Ayyappa Chaturvedula

Student Learning Outcome 2

Demonstrate proficiency in the usage of software programs required for pharmacometric analysis.

Is the outcome direct or indirect?

Direct

Description of Assessment

Performance in PHAR 7383 and PHAR 7384.  Course-embedded assignments in which students 1) use software tools to develop PK and PD models and 2) use software tools to develop PK and PD models to inform dosing decisions at various stages in a realistic drug development case.

Criteria for Achievement

80% of the class with a grade of B or above in courses PHAR 7383 and PHAR 7384

 Time Table

End of each course

Responsible Individuals

Dr. Tina Machu and Dr. Ayyappa Chaturvedula

Program Performance Outcome

Provide knowledge and software skills required for conducting pharmacometrics analysis and apply in clinical pharmacology.

 Is the outcome direct or indirect?

Direct

Description of Assessment

Performance in all five courses in the certificate program: PHAR 7380, PHAR 7381, PHAR 7382, PHAR 7383, and PHAR 7384.  Course-embedded assignments in which students 1) use statistical software to understand and evaluate various pharmacokinetic (PK) and pharmacodynamic (PD) models and their assumptions in drug development research; 2) use statistical principles related to PK and PD modeling and simulation activities; 3) critically assess various applications of pharmacometrics in conducting clinical pharmacology studies in drug development; 4) use software tools to develop PK and PD models and 5) use software tools to develop PK and PD models to inform dosing decisions at various stages in a realistic drug development case.

Criteria for Achievement

80% of the class with a grade of B or above in the five courses in the certificate program.

Time Table

End of each course

Responsible Individuals

Dr. Tina Machu and Dr. Ayyappa Chaturvedula