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Good Oral Candidates 101


The ability to achieve the requisite systemic exposures is critical to the success of preclinical safety studies, as well as to the viability of new drug candidates in the clinic. When an exposure issue is encountered, it is essential to understand the contribution of physicochemical and pharmacokinetic properties to the problem so that the correct strategy can be used to enhance exposure. This course will focus on challenges encountered with the oral delivery of drug candidates and provide a step-by-step guide through the fundamentals of achieving optimal oral exposure. After attending all lectures the participants will have a high level of understanding in:
  • Oral absorption and the impact of phase and formulation design
  • GI physiology
  • Drug metabolism and transporters
  • In-vitro and in-vivo screening tools
  • PBPK-based approaches to model oral absorption

Course Objectives

This new comprehensive AAPS online training course was developed for those interested in learning more about drug development for oral candidates. This course will step through the fundamentals of achieving good oral exposure. Upon completion of this eCourse lecture, the participant should be able to:
  1. Discuss the physiochemical properties impacting oral absorption, including solubility, dissolution rate and permeability;
  2. Explain how the gastrointestinal tract influences drug absorption from oral drug delivery systems;
  3. Describe the Biopharmaceutical Classification System and its use in predicting drug disposition;
  4. Discuss the importance of high hepatic clearance and its impact on pharmacodynamics;
  5. List the advantages, disadvantages and specific purposes for using preclinical models involving rats, dogs, monkeys or minipigs;
  6. Describe the challenges in pharmaceutical toxicology formulation development;
  7. Discuss the role of physiologically relevant solubility and permeability assays with respect to the BCS and BDDCS classification systems;
  8. Describe the relevance of enzymes, uptake and efflux transporters on the disposition of drugs within each BDDCS class;
  9. Discuss the utility of projecting human pharmacokinetics and dose for new chemical entities prior to start of clinical trials;
  10. Discuss the application of absorption modeling for understanding candidate compound’s in vivo performance; and
  11. Explain how to build predictive models.
AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.

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