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Home » Conducting Pharmacokinetic and Pharmacodynamic Studies

Conducting Pharmacokinetic and Pharmacodynamic Studies (PKPD02)

Certification Training
 
Rated 4.38/5
8 reviews
Method of Training: Online / Self-paced eLearning.
Credits: 1.5 CPD Credits.
Duration: ~1.5 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Drug Safety.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $189.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Conducting Pharmacokinetic and Pharmacodynamic Studies
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


COURSE OUTLINE:


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.

COURSE OBJECTIVES:


Who will benefit from this module?
Pharmacologists, nonclinical researchers, clinical researchers, regulatory affairs staff, and others who contribute to drug development and registration will benefit from this module.

Objectives
  • Summarise the advantages, and how to counteract the main weakness, of the core design of choice for many pharmacokinetic and pharmacodynamic studies
  • Adopt good sampling practice
  • Discuss non-compartmental and compartmental data analysis
  • Describe the rationale and characteristics of studies in special populations
  • Describe how to carry out bioequivalence testing

The Conducting Pharmacokinetic and Pharmacodynamic Studies Course is Included in the Following Professional Certification Programs:


Pharmacokinetics and Pharmacodynamics Professional Certification Program: This professional certification program will provide the student with a comprehensive overview of pharmacokinetic and pharmacodynamic. Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge betw ... Learn more

Good Pharmacoepidemiology Practice Professional Certification Program: This professional certification program will provide the student with a comprehensive overview of the requirements and concepts necessary for a strong understanding in good pharmacoepidemiology practice (GPP), ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

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.

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