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Pediatric development, including non-clinical safety evaluation, is an essential and unique part of the drug-development process.An appropriate pediatric strategy and plan needs to be developed timely based on the compound class / indication and many pediatric population related features to support clinical trials and regulatory needs without any delays or gaps, and this challenge will be illustrated through specific examples.First, it is critical to understand the dynamic global regulatory environment for pediatric development (e.g., history of the US FDA and EU EMA pediatric regulations/guidance while ICH S11 and CFDA pediatric guidelines still under development).Regulations require an approved pediatric plan (even an application/justification of deferral/waiver request) to assess efficacy/safety in pediatric patients prior to NDA/MAA submission, and how to develop a global regulatory pediatric plan and how to best dialogue with the global regulatory agencies will be presented.Secondly, pediatric safety issues are unique and related to organ system development, and an overall non-clinical pediatric plan needs to be developed based on a thorough "gap" analysis.It is important to know that there are differences in drug safety profiles between adult and pediatric patients, and pediatric toxicities are not always predicted by adult studies.In addition, it is necessary to identify when juvenile animal (JA) toxicology studies are not needed; when JA studies are warranted and timing of non-clinical studies.Furthermore, JA study objective, design, conduct, and report will be discussed.Juveniles are not little adults, so many special considerations are needed for JA studies, including no standard study design/endpoints and a case-by-case basis to fit the pediatric clinical plan, unpredictable dose range finding outcome and/or TK profile for dose selection, comparative development for treatment period (age at initiation/end of dosing), practical issues (e.g., feasible dosing route / age / formulation / volume, blood sampling, litter considerations, lab animal husbandry capacity), specific interpretation and discussion required for the JA study results, and impact on pediatric patients.Lastly, a variety of case studies/discussions, consisting of different JA study designs, unpredictable systemic exposure at pre-and post-weanling, how to maintain systemic exposure throughout the JA study via a dose escalation, and age limit and warning in label implications, will be included.