Fundamentals of Pharmacokinetics

Pharmacokinetics are fundamental throughout drug discovery and development. The assessment of the pharmacokinetic profile on new chemical entities reduces the failure during development making the process more efficient. The pharmacokinetics of each drug is different due to its physical-chemical characteristics. The course will describe all the processes determining the pharmacokinetics of a drug and their relationship. The course will not use complex mathematics to explain the concepts and assume no previous knowledge in pharmacokinetics.

• To learn what are the key chemical and physiological factors affecting the absorption, distribution, metabolism, and excretion (ADME) of a drug
• To learn the impact of absorption, distribution, metabolism, and excretion (ADME) in defining the behavior of a drug after administration
• To learn how the analysis of pharmacokinetic data in conducted
• To learn the meaning of elimination half-life, clearance, and volume of distribution
• Defining the relevance of ADME from both the safety and efficacy standpoints
• To understand the relevance of pharmacokinetics in drug discovery and development

• Absorption
• Distribution
• Metabolism
• Excretion
• Elimination half-life
• Clearance
• Volume of distribution

Professional in the pharmaceutical industry, academia, and contract research organizations need to be familiar with the fundamentals of pharmacokinetics. This will allow an optimal design of the various pre- and clinical studies as well as a better communication with other peers. Pharmacokinetics is relevant in many areas of drug discovery and development and a basic knowledge of this discipline of those involved in R&D will streamline the overall projects.

Professionals involved in project management, clinical operation, regulatory, manufacturing, marketing, medical writers, quality assurance, graduate students in the pharmaceutical R&D sector. Pharmaceutical technology managers, pharmacovigilance managers, toxicology managers, pharmacology managers, medical affair managers, business development managers,

Dr. Stefano Persiani is within the Internal & External Innovation, Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy since the year 2000. Dr. Persiani received his Ph.D. in Pharmacy from the University of Milan, in Italy and completed his Post-Doctoral fellowship in the Department of Pathology of the University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania, USA. After his Post-Doctoral Fellowship, Dr. Persiani served as Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic experiences, he entered the pharmaceutical industry in Farmitalia Carlo Erba, Pharmacia, and Upjohn, and Zambon Group and also as the Scientific Director in clinical pharmacology CROs.

Dr. Persiani experience consists in translational approaches for drug discovery and development for successful drug discovery and development. Regulatory pre-clinical development package and early clinical development. Dr. Persiani 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. Dr. Persiani is also an expert evaluator for La Caixa Foundation and for the Slovak Republic’s Research Agency. Dr. Persiani is a faculty of the University of Milan Bicocca, School of Medicine and a trainer at Pharmaceutical Training International, Traininng.com, GRC educators, and Compliance IQ where he provides lectures and training courses to pharmaceutical companies.