Student Login |


Thursday, March 28, 2024
Home » Conducting Pharmacokinetic and Pharmacodynamic Studies

Conducting Pharmacokinetic and Pharmacodynamic Studies

Conducting Pharmacokinetic and Pharmacodynamic Studies Certification Training

 
Rated 4.1 / 5
(15 reviews)

Program/Course ID:PKPD02
Enrollment Period:12 months.
Average Learning Time:~90 minutes.
Additional Resources:Supplemental materials/activities.
Accredited Program:1.5 CPD Credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Catalog:Drug Safety.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
Special New Year 25% Discount:Use this discount code: 2024NEWYEAR.
Discounted Price:
   $141.75 USD  
  Price: $189.00 USD  
CPD Accredited Training

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

Training 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 enrollment.

Description:
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.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.


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 minimizing bias and maximizing 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.

Objectives:


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

Objectives
  • Summarize 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

This Course is Included in the Following Professional Certification Program(s):



Training Program For Professionals:

Pharmacokinetics and Pharmacodynamics for Professionals

Course ID: AV01A
Price: $359.00 (USD)

Professional Certification Program:

Good Pharmacoepidemiology Practice Professional Certification Program

Program ID: AV01B
Price: $1195.00 (USD)

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


Use our Search Form to Find What You're Looking For:

  

Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.


Have Questions? Contact Us:


Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

Name:
Company:
Phone:
Email:
 
Enter the number from the image above:
Comments:


For quotes or invoices please provide the course(s) and number of students.