|Credits: 1.5 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Drug Safety.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $189.00
Training Program: Conducting Pharmacokinetic and Pharmacodynamic Studies
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
This course extends the learner’s understanding of pharmacokinetic and pharmacodynamic studies from the basics described in our companion module PKPD01, An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration. It provides detail on a variety of aspects of such studies: design, sampling, data analysis, research in special populations, and bioequivalence testing.
This is an online training course with immediate access upon online enrollment. Username, password, and instructions will be immediately emailed to the student following an online order. Program includes high-quality animations, progress checks, easy navigation, and voice-overs. Some select training programs make available references and/or course notes in PDF format. Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can take the final assessment any number of times, as needed, in order to achieve a passing grade.
Benefits of Getting Certified at BioPharma Institute
By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. With its advanced learning techniques, the BioPharma Institute uses proven methods to assist professionals and corporations with maintaining training records, educating employees, and offering an overall improvement in the quality of service you offer. The BioPharma Institute has the course content and the experience required to deliver the high-quality training to your employees, you, and your colleagues. This will help to achieve professional objectives, further careers, and assist with continued success.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
Online Training Programs Include:
The Conducting Pharmacokinetic and Pharmacodynamic Studies course is found in the following professional certification program(s):
Course overview – An outline of the module’s scope and objectives, and notes on terminology.
Study design – In this session we discuss the core design of choice for many PK and PD studies: crossover. We outline its advantages and how to counteract an important weakness, which is the carry-over effect.
Sampling practice and outcomes – Arguably the most important aspect of the design of a PK or PD study is the sampling schedule. How many samples should be taken per subject and at which time points after dosing? Choice of these factors is crucial in minimising bias and maximising the precision of results. In this session we explain principles of good practice in sampling.
Data analysis – In this session, after introducing the principal pharmacokinetic parameters, we describe the PK and PK/PD characteristics of each drug administration route. We discuss the different medical-scientific questions to be addressed by PK/PD research for the different routes.
Special populations – Drug development entails research not only into the target population as a whole but into sub-populations with a common demographic or health characteristic that may produce treatment outcomes that differ significantly from the average. In this session we discuss such special populations and how they are studied.
Generics and bioequivalence – Licensing of generic drugs is an area in which pharmacokinetic studies constitute the prime determining factor. In the great majority of cases the test that determines the licensing of a generic drug is a comparison of its plasma concentration-time course with that of the product it copies -a bioequivalence test- to assess whether they are sufficiently similar. In this session we describe how to carry out bioequivalence testing.
Assessment – Multiple-choice mastery assessment.
Who will benefit from this module?
For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.