Pharmacokinetics (PK) and pharmacodynamics (PD) play a key role in drug development, and a good understanding of the implications of PK/PD data is crucial when designing clinical trials or preparing a drug submission dossier. As a professional working with PK/PD data on a regular basis, you must have a solid understanding of the topic to communicate effectively with the development teams - a daunting and challenging task, due to the breadth and complexity of the topic area.
The Fundamentals of Pharmacokinetics Masterclass assumes no prior PK knowledge and aims to give you a broad understanding of this fascinating subject, using multiple case studies and relevant examples. You will learn what pharmacokinetics involves, what data is collected, and its impact on the drug development process. By learning these skills, you will be able to understand, communicate, and challenge the data presented to you.
Understand the PK/PD model of therapeutics. Dose, concentration, BioPhase, effect, clinical endpoints
Understand the importance of PK throughout the phases of drug development
Gain insight into the role of PK in Drug Development
Study the volume of distribution of small molecule vs biological products
Discuss the physiological relevance and interrelationship between clearance, volume of distribution, and half-life
Examine PK studies using radiolabeled drugs
Assess the effects of drug interactions on the potential profitability of a candidate drug
Understand EMA guidelines: Pediatric, hepatically impaired, renally impaired, peptides and proteins
Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmacy at the University of Milan, Italy and completed a post-doctoral fellowship in the Department of Pathology of the University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania, USA, and later as a Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic positions, he entered the pharmaceutical industry at Farmitalia Carlo Erba, Pharmacia, Upjohn, and Zambon Group and in the CRO sector with different managerial roles in drug R&D. Dr. Persiani is currently applying translational approaches from drug discovery to development and registration in several therapeutic areas. He is a member of various international scientific societies and serves on the review board of numerous professional journals. Dr. Persiani acts as an external expert evaluator for the European Commission on the 7th Framework Program, Maria Sklodowska-Curie Individual Fellowships, HORIZON 2020, and Innovative Medicine Initiative, and for several other government organizations where he evaluates and provides recommendations on applications requesting funding. Dr. Persiani has many years of teaching and training experience in several fields of Translational Sciences.