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Application of Pharmacometric Methods to Improve Pediatric Drug Development Virginia Commonwealth University VCU Scholars Compass Theses and Dissertations Graduate School 2011 Application of Pharmacometric Methods to Improve Pediatric Drug Development Mallika Lala Virginia Commonwealth University Follow this and additional works at: https://scholarscompass.vcu.edu/etd Part of the Pharmacy and Pharmaceutical Sciences Commons © The Author Downloaded from https://scholarscompass.vcu.edu/etd/2467 This Dissertation is brought to you for free and open access by the Graduate School at VCU Scholars Compass. It has been accepted for inclusion in Theses and Dissertations by an authorized administrator of VCU Scholars Compass. For more information, please contact [email protected]. School of Pharmacy Virginia Commonwealth University This is to certify that the dissertation prepared by Mallika A. Lala entitled APPLICATION OF PHARMACOMETRIC METHODS TO IMPROVE PEDIATRIC DRUG DEVELOPMENT has been approved by her committee as satisfactory completion of the dissertation requirement for the degree of Doctor of Philosophy (Ph.D.) Jogarao V.S. Gobburu, FDA and F. Douglas Boudinot, School of Pharmacy Jurgen Venitz, School of Pharmacy Patricia W. Slattum, School of Pharmacy D’arcy P. Mays, College of Humanities and Sciences Susanna Wu-Pong, Graduate Program Director, School of Pharmacy Victor A. Yanchick, Dean, School of Pharmacy Dr. F. Douglas Boudinot, Dean of the Graduate School May 9th, 2011 i © Mallika A. Lala 2011 All Rights Reserved ii APPLICATION OF PHARMACOMETRIC METHODS TO IMPROVE PEDIATRIC DRUG DEVELOPMENT A dissertation submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy at Virginia Commonwealth University. by MALLIKA A. LALA Bachelor of Pharmaceutical Science, UICT, India, 2006 Ph.D. in Pharmaceutical Science, VCU School of Pharmacy, 2011 Co-advisor: JOGARAO V.S. GOBBURU, Ph.D. Director, Division of Pharmacometrics, U.S. Food and Drug Administration Co-advisor: F. DOUGLAS BOUDINOT, Ph.D. Professor, School of Pharmacy, Virginia Commonwealth University Virginia Commonwealth University Richmond, Virginia May 2011 iii Acknowledgement This dissertation is dedicated to my deceased grandfather Mr. Murli Lala, the need to fulfill whose last desire of me led me to the U.S. to obtain my Ph.D. I dedicate this work also to my parents, Anil and Mita Lala, whose unconditional love and support is integral to my success. There are several people who warrant acknowledgement. The person I thank first and with utmost gratitude is my advisor Dr. Joga Gobburu. He has been the best mentor I could ask for, a friend and role model. He not only bailed me out of a crisis that struck mid-way through my degree program but also provided me with the rare opportunity to complete my dissertation research at the FDA. He has taught me to learn and apply and has helped me transform into an independent thinker and researcher. I owe most of my professional prowess to him. Thank you very much. The next person I thank whole-heartedly is my advisor Dr. Douglas Boudinot. He stepped up to shoulder my responsibility and support me through the finish of my degree when I was in need. He has been a kind and helpful mentor and a solid anchor for me at VCU. Sincere thanks to you Dr. Boudinot. I thank all my committee members – Dr. Patrcia Slattum, Dr. Jurgen Venitz and Dr. D’Arcy Mays for their constant guidance and support along the entire course of my research. They have helped me think through my work and provided valuable feedback. In particular, I thank Dr. Slattum who has always been there as a guide and friend through my five years at VCU, helping me in several ways. I also thank Dr. David Holdofrd for his motivating words and for being a helpful member of my original committee. iv My colleagues at the Division of Pharmacometrics at FDA all warrant a special acknowledgement. I have learnt tremendously from the unique, stimulating work environment they create together. My particualr thanks to Dr. Pravin Jadhav, Dr. Satjit Brar, Dr. Yaning Wang and Dr. Christopher Tornoe for mentoring and befriending me and helping me develop the skills I have. Finally, I acknowledge the ones whose love and faith have made this possible – my family and friends. My parents have provided me with the best possible education and much more. They are the anchor that enables me to seek independence and excellence. My brother and his wife, Amit and Janaina Lala, have been constant believers and silent pillars of support. My friends, who are the sole reason I have survived life away from home over these five years. My most heart-felt thanks goes to Raunak, who has incessantly been there by my side through all experiences that came my way, good and bad. He has helped me sail through this journey being my stressbuster and technological guide.☺ Priyanka and Parinaz have filled in the shoes for family and given me the love, backing and nurture that never let real home-sickness kick in. Raunaq has been my go-to person when I’ve needed any counseling and an unfailing support system. Avinash, who although joined me towards the end of this journey, has been the prime source of comfort and encouragement that saw me through the most difficult and trying last sprint. All of my friends back home in Bombay have been well-wishers and believers in my potential. I’m elated and grateful to have finally reached here. Thank you everyone! v Table of Contents Acknowledgement ............................................................................................................. iv List of Tables ...................................................................................................................... x List of Figures.................................................................................................................... xi List of Abbreviations ........................................................................................................ xii Abstract............................................................................................................................ xiv CHAPTER 1: Pharmacometrics: Concepts and Applications to Drug Development................................ 1 Abstract............................................................................................................................... 1 What is Pharmacometrics?.................................................................................................. 2 Disease models.................................................................................................................. 11 Population analysis ........................................................................................................... 16 Types of data and trial designs.......................................................................................... 22 Case studies....................................................................................................................... 25 Perspective ........................................................................................................................ 39 Reference List ................................................................................................................... 42 CHAPTER 2: Pharmacometric Analyses Impact Pediatric Drug Approval and Dosing......................... 47 Abstract............................................................................................................................. 47 vi Introduction....................................................................................................................... 48 Applications of pharmacometric analyses ........................................................................ 51 Future Perspective............................................................................................................. 58 Conclusion ........................................................................................................................ 59 Reference List ................................................................................................................... 59 CHAPTER 3: Simulation-based Methodology for using PK Quality Standard to Design Pediatric Trials in the Population Analysis setting..................................................................................... 63 Abstract............................................................................................................................. 63 Introduction....................................................................................................................... 65 Methods............................................................................................................................. 69 Results............................................................................................................................... 81 Discussion......................................................................................................................... 88 Reference List ................................................................................................................... 96 CHAPTER 4: Covariate models – do not center at values outside the data range .................................. 98 Abstract............................................................................................................................. 98 Introduction....................................................................................................................... 99 Methods............................................................................................................................
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