Did pediatric drug development advance epilepsy treatment in young patients?It is time for new research goals

Modern drugs have changed epilepsy,which affects people of all ages.However,for young people with epilepsy,the framework of drug development has stalled.In the wake of the thalidomide catastrophe,the misconception emerged that for people<18 years of age drugs,including antiseizure medications(ASMs),need separate proof of efficacy and safety,overall called"pediatric drug development".For ASMs,this has changed to some degree.Authorities now accept that ASMs are effective in<18 years as well,but they still require"extrapolation of efficacy,"as if minors were another species.As a result,some of the pediatric clinical epilepsy research over the past decades was unnecessary.Even more importantly,this has hampered research on meaningful research goals.We do not need to confirm that ASMs work before as they do after the 18th birthday.Instead,we need to learn how to prevent brain damage in young patients by preventing seizures and optimize ASMs’uses.Herein we discuss how to proceed in this endeavor.

Analysis and Enlightenment of Pediatric Drug Registration Data in China

Objective To analyze the current status of pediatric drug development in China from the perspective of pediatric drug registration and clinical trials so as to provide a reference for its improvement.Methods The registration and clinical trials explicitly labeled as pediatric drugs were analyzed by using the Insight Database,National Medical Products Administration(NMPA),and other publicly available information.Results and Conclusion The number of applications for pediatric drug registration was 196,and 104 were for domestic drugs,accounting for 53.06%.The number of pediatric drugs included in the priority review was 116,and 70.18%have completed the review.However,the number of new pediatric drug marketing applications is still not optimistic.Only 5 applications for pediatric drug registration are accepted by Center for Drug Evaluation(CDE),accounting for 4.63%.There are difficulties in recruiting pediatric subjects in clinical trials,with 42.08%of completed recruitment projects.Besides,there are few institutions for drug clinical trials,the distribution of institutions and professional certification are uneven.Therefore,enterprises should be encouraged to carry out research and development of pediatric drugs from two aspects:improving the policy for pediatric drugs and strengthening the clinical management of pediatric drugs to guarantee their safe use.

Pediatric ocular nanomedicines：Challenges and opportunities

The eye is a highly complex,yet readily accessible organ within the human body.As such,the eye is an appealing candidate target for a vast array of drug therapies.Despite advances in ocular drug therapy research,the focus on pediatric ocular drug delivery continues to be highly underrepresented due to the limited number of degenerative ocular diseases with childhood onset.In this review,we explore more deeply the reasons underlying the disparity between ocular therapies available for children and for adults by highlighting diseases that most commonly afflict children（with focus on the anterior eye） and existing prognoses,recent developments in ocular drug delivery systems and nanomedicines for children,and barriers to use for pediatric patients