PPT-Extrapolation in Pediatric Drug Development: An Evolving Science

Lynne P Yao MD Director Division of Pediatric and Maternal Health Center for Drug Evaluation and Research US FDA September 13 2018 Disclosure Statement I have no financial relationships to disclose relating to this presentation. Drug companies are required to provide substantial evidence that the drug is effective This has generally been defined as at least 2 adequate and well controlled investigations or clinical trials FDA has been flexible within the statutory requiremen Directed Readings . In the Classroom. October/November 2012 . issue of . Radiologic . Technology. Instructions:. This presentation provides a framework for educators and students to use Directed Reading content published in . A new proposal to foster greater orphan drug development. 1. The OPEN ACT. O. rphan. . P. roduct. . E. xtensions. . N. ow. A. ccelerating. . C. ures. . &. . T. reatments. www.CureTheProcess.org. Arizona . Pediatric Emergency . Preparedness. Sue Moravec, PharmD. Chief Pharmacy Officer/AVP . Pharmacy Services. May 23. rd. , 2017. Disclosure. Nothing to . disclose. Except….. Planning Pediatric Drug Shortage. Directed Readings . In the Classroom. October/November 2012 . issue of . Radiologic . Technology. Instructions:. This presentation provides a framework for educators and students to use Directed Reading content published in . Pediatric Patients. All patients younger than16 years. Respond differently to drugs than the rest of the population. More sensitive . to drugs than other patients are. Show . greater individual . variation. February 28, 2012. Lacy-Ann . Landell. , MD. Ryan Morgan, MD. Improving Research, Development, Access, and Safety of Pediatric Drugs and Medical Devices. Overview. Background. Barriers to the development and access of pediatric drugs and devices. Allison Baxterbeck. Elizabeth Chang. Amy . DiPilato. Case. The mother of your 5 year old clinic patient brings her daughter in for a walk-in appointment. The child has had 3 days of URI symptoms. On exam, she is afebrile with normal vital signs for age. She is well appearing and in no distress, but does have nasal congestion and a mild cough. Her mother asks you, “What cough medicine is safe to give her?”. EMA/189724/2018Page 2/20Reflection paper on the use of extrapolation in the development of medicines for paediatrics FinalTableof contentsExecutive summary1 Introduction2 Scope3 Legal basis and releva Jennifer . kean. MSN, RN, CCRN. dosing. Most drugs for children are dosed according to body weight (mg/kg) or body surface area (BSA) . Care must be taken to convert body weight from pounds to kilograms before calculating doses based on body weight. Dr Arif Hashmi. Objectives. a. . Discuss the principles of prescribing in . pediatric . and geriatric age groups. . b. Discuss the pharmacokinetic and pharmacodynamics differences in . pediatric, . geriatric and adult age groups. . How the cauliflower had its revenge. OR. Three areas. Pharmacometric problem. Designing pediatric regimens to produce drug exposure that matches adults. Quantifying and managing variability. Ideas of control and dosage individualization. in vitro. to . in vivo. and across species. Pierre-Louis Toutain. Royal veterinary College London & project officer at the ENV of . Toulouse . Wuhan University October 2017. How to determine a dose?. Dr Arif Hashmi. Objectives. a. . Discuss the principles of prescribing in . pediatric . and geriatric age groups. . b. Discuss the pharmacokinetic and pharmacodynamics differences in . pediatric, . geriatric and adult age groups. .