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Tuesday, December 11, 2018
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An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration (PKPD01)

Certification Training CPD Accredited TrainingCredits: 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

BioPharma Institute LogoTraining Program: An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available 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 programme, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval.

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.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


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:

  • Immediate access to training: Instructions, user name, password and receipt of payment 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 training: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration course is found in the following professional certification program(s):


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


COURSE OUTLINE:


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.

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

  • Describe the role of pharmacokinetics and pharmacodynamics in drug development and registration

  • Describe ways in which drug safety / pharmacovigilance is regulated nationally and internationally, and identify international policy-making bodies.

  • Identify the main types of pharmacokinetic and pharmacodynamic studies conducted during drug development, their goals, and the uses of the data obtained

  • Outline the pharmacokinetic characteristics of the various routes of drug administration

  • Discuss how in-vivo pharmacodynamic studies provide a bridge between science and medicine in drug development and registration


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.

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