K. LakshmiChettinad Academy of Research and Education, India
Title: PBPK Models in Dosage Form Design
A drug’s pharmacokinetics (PK) is important as it dictates the pharmacological activity and therapeutic response. When it comes to paediatric population, a number of anatomical and physiological factors determine the pharmacokinetic profile of a drug and thereby becomes a challenging task to determine the exact dose to be given especially when children in the paediatric age group tend to be growing at a rapid rate. Traditionally, pediatric doses were calculated via allometric scaling, which has its own demerits. It is currently recognized that the research into the design of paediatric doses can be predicated using Physiology-based Pharmacokinetic modelling (PBPK) approaches. A combination of bottom-up, middle-out and top-down methods can help design mathematical models using PBPK tools to serve as an appropriate dose calculation method for the paediatric age group. Some of the uses of these models include dosage form design, formulation modification (IR to ER) for paediatric use and understanding of toxicity. PBPK modeling, though with its limited exposure has gained popularity with the introduction of Paediatric exclusivity programs by regulatory bodies such as US-FDA and EMA.
K. Lakshmi has completed her PhD at the age of 36 years from SRM University, Chennai. She is now working as Professor and Dean at Chettinad School of Pharmaceutical Sciences, Chettinad Academy of Research and Education, India. She has 72 publications with 598 citations and h-index of 15. She is also serving as editorial board member and reviewer in many National and International Journals. She has visited Amsterdam and Turkey for the conferences. She has delivered 50 invited talks in various workshops, conferences and faculty development programs.