Enrollment Period: 3 months.
Average Learning Time: ~90 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1.5 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Drug Safety.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
PRICE: USD $189.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a drug development program, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.
Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.
Course overview - An outline of the module's scope and objectives, and notes on terminology.
Role of pharmacokinetics and pharmacodynamics - Although pharmacokinetic (PK) and pharmacodynamic (PD) studies are routinely carried out in nonclinical and clinical stages of drug development, their role is perhaps less well understood than it ought to be by those who are not specialists in the field. In addition, greater emphasis is being placed by regulators on the value of PK and PD data. Evidence of good practice in the execution of PK and PD studies, and sound understanding of the implications of their findings, are becoming increasingly important in drug registration. In this session we define PK and PD, outline the uses of PK and PD data in a drug development programme, and give examples of how good practice in obtaining and interpreting PK and PD data can contribute to the minimisation of risk for a drug.
PK and PD studies in drug development - In this session we discuss the various types of study carried out to acquire pharmacokinetic and pharmacodynamic data, grouping them into those conducted in animals only, in animals and humans, and in humans only. We identify their goals, rationale, and place in a drug development programme.
Drug administration routes - 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.
Pharmacodynamic studies - In this session we discuss the scope of pharmacodynamics, distinguish pharmacodynamic from clinical outcomes, and outline how the former may be used as surrogates for the latter. The core information from PD studies is a quantitative description of the dose-response relationship and the influence of various factors on this relationship. We emphasise the importance of interpreting the shape of the dose-response curve in making major decisions on a drug's development. Finally, we discuss factors that can influence the beneficial and adverse effects of a drug.
Assessment - Multiple-choice mastery assessment.
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.
Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration is Included in the Following Professional Certification Program(s):
Pharmacokinetics and Pharmacodynamics Professional Certification Program
Course ID: AV01A
Price: $359.00 (USD) | Learn more
Good Pharmacoepidemiology Practice Professional Certification Program
Course ID: AV01B
Price: $995.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.
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 (1-100 students) and large-scale (100+ students) training requests.
Online Training: The Benefits of Remote Learning & 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 training reimbursement policy.
- 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.