Assessment of Drug Interactions in Drug Development


Drug-drug interactions are a common problem and result in hospital admissions for medically important and even fatal adverse events. Drug-drug interactions can also cause partial or complete abolishment of treatment efficacy. The ageing population, where polypharmacy is more frequent, increases the likelihood of such interactions and underlines the importance of a scientifically sound understanding of the potential for drug-drug interactions for all new chemical entities. The potential for pharmacokinetic interactions between new medicinal products and already marketed drugs should be evaluated as most drug-drug interactions are pharmacokinetic in nature. During the assessment of drug interactions, both the effects of the medicinal product on other drugs as well as the effect of other drugs on the medicinal products should be investigated. The drug-drug interaction potential is usually investigated through in vitro studies followed by clinical studies. Treatment recommendations are developed based on the clinical relevance of the interactions and the possibility to make dose adjustments or treatment monitoring. The webinar will provide the basic concepts of drug interactions and their use in drug development and will describe how drug interactions studies should be designed and how they have been used successfully by reviewing a case study.

Course Objectives:

• You will get a better understanding on the risk, evaluation, and interpretation of drug-drug interaction in drug development
• Definitions and the mechanisms responsible for drug interactions
• Which patients are at higher risk of experiencing drug interactions
• How to design the in vitro and the clinical drug interaction studies to add value to your drug development program also in comparison with competitors
• Difference between drug interactions mediated by metabolic enzymes and those mediated by transporters
• Assessment of drug interactions can streamline your drug development program in line with regulatory expectations

Why Should You Attend:

An effective evaluation of the potential of a new drug to elicit clinically relevant drug interactions is essential for the overall success of any drug development program. In this webinar expert speaker Stefano Persiani will focus on the basics of an effective assessment program to predict the drug interaction potential both in vitro and in clinical trials. A case study will be described to further provide focus on the concepts discussed.

Why Should You Attend:

An effective evaluation of the potential of a new drug to elicit clinically relevant drug interactions is essential for the overall success of any drug development program. In this webinar expert speaker Stefano Persiani will focus on the basics of an effective assessment program to predict the drug interaction potential both in vitro and in clinical trials. A case study will be described to further provide focus on the concepts discussed.

Course Outline:

• Understanding the jargon related to drug interactions
• Understanding the causes of clinically relevant drug interactions
• Understanding the use of in vitro models to assess the drug interaction potential
• Learn how to design a clinical trial to evaluate drug interactions
• Effective steps during the implementation of a drug interaction evaluation program
• Review of the regulatory guidance for the assessment of drug interactions
• Case study

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Project managers
• Licensing managers
• Toxicology specialists
• Medicinal chemists
• Senior management
• Regulatory specialists
• Preclinical pharmacologists
• Clinical pharmacologists
• Clinical Research Associates
• Clinical study monitors
• Pharmacists
• Consultants

Dr. Stefano Persiani,

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 as Scientific Director for Clinical Pharmacology. Dr. Persiani in his current role applies translational approaches from drug discovery to development and registration in several therapeutic areas. 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 where he evaluates and provides recommendations to the bank on applications requesting funding. Dr. Persiani is a faculty of the University of Milano Bicocca, School of Medicine, and provides on-line training to pharmaceutical companies executives in several fields of Translational Sciences through SignupTraining.com.

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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