| 期刊論文| 1. | 蔡慧珊(2003)。無許可證及非仿單標示處方於兒童之安全性。成醫藥誌，13(1)，1-3。 延伸查詢 | | 2. | Bain, Lisa(2005)。Crossroads in Clinical Trials。NEURO RX，2，525-528。  | | 3. | Barnes, Pamela(2008)。Inside the Medicine Cabinet: Making Children's medicines Growing up Issue。Journal of Pharmaceutical Science，97，5074-5079。 | | 4. | Cohen, I. Glenn(2003)。The Therapeutic Orphans, Pediatric Victims? The Best Pharmaceuticals for Children Act and Existing Pediatric Human Subject Protection。Food and Drug Law Journal，58，661-709。 | | 5. | Glover, Gregory(2007)。The Influence of Market exclusivity on Drug Availability and Medical Innovations。AAPS Journal，9，E312-E316。 | | 6. | Hall, Ralph、Braun, Tracy(2008)。Leaving No Child Behind? Abigail Alliance, Pediatric Products and Off-label Use。Houston Journal of Health Law and Policy.，8，271-313。 | | 7. | Jerles, Lisa(2008)。Note: The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act-Helping or Hurting America's Children?。Cardozo Public Law, Policy and Ethics Journal，6，515-545。 | | 8. | Kushner, Leslie(2009)。Incentivizing Postmarketing Pharmaceutical Product Safety Testing with Extension of Exclusivity Periods。Fordham Intellectual Property, Media and Entertainment Law Journal，19，519-556。 | | 9. | Li, Jennifer、Eisenstein, Eric、Grabowski, Henry、Reid, Elizabeth、Mangum, Barry、Schulman, Kevin、Goldsmith, John(2007)。Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program。JAMA，297，480-488。 | | 10. | Lynch, Holly(2007)。Give Them What They Want? The Permissibility of Pediatric Placebo-Controlled Trials the Best Pharmaceuticals for Children Act。Annals of Health Law，16，79-138。 | | 11. | Milne, Christopher-Paul、Bruss, Jon(2008)。The Economics of Pediatric Formulation Development for Off-Patent Drugs。Clinical Therapeutics，30，2133-2145。 | | 12. | Milne, Christopher-Paul(2002)。Exploring the Frontiers of Law and Science: FDAMA's Pediatric Studies Incentive。Food and Drug Law Journal，57，491-517。 | | 13. | Noah, Barbara(2009)。Just a Spoonful of Sugar: Drug Safety for Pediatric Populations。Journal of Law, Medicine and Ethics，37，280-286。 | | 14. | Shirkey, Harry(1968)。Editorial Comment: Therapeutic Orphans。Pediatrics，72，119。 | | 15. | Standing, Joseph、Khaki, Zahra、Wong, Ian(2005)。Poor Formulation Information in Published Pediatric Drug Trial。Pediatrics，116，559-562。 | | 16. | Tabor, Edward(2009)。FDA requirements for clinical studies in pediatric patients。Regulatory Focus，14，16-21。 | | 17. | Thorat, Chandana、Xu, Kui、Freeman, Scott N.、Bonnel, Renan A.、Joseph, Francesca、Phillips, M.、Ian Imoisili, Menfo A.(2012)。What the Orphan Drug Act Has Done Lately for Children With Rare Diseases: A 10-Year Analysis。Pediatrics，129，516-521。 | | 18. | Ward, R. M.、Kern, S. E.(2009)。Clinical Trials in Neonates: A Therapeutic Imperative。Clinical Pharmacology and Therapeutics，86，585-587。 | | 19. | Wendler, David、Rackoff, Jonathan、Emanuel, Ezekiel、Grady, Christine(2002)。The Ethics of Paying for Children's Participation in Research。Journal of Pediatrics，141，166-171。 | 會議論文| 1. | Weiss, Karen(20070531)。FDA Background Package for June 27, 2007 Meeting。 | 研究報告| 1. | Thomas, John(2006)。Proprietary Rights in Pharmaceutical Innovation: Issues at the Intersection of Patents and Marketing Exclusivities。 | 圖書| 1. | Clothier, Anne(2009)。Pediatric Market Dynamics。PEDIATRIC DRUG DEVELOPMENT。U.S.A.：John Wiley & Sons。 | | 2. | GAO(2009)。Pediatric Drug Research: The Study and Labeling of Drugs for Pediatric Use under the Best Pharmaceuticals for Children Act。SAFETY EFFORTS IN PEDIATRIC DRUG DEVELOPMENT。U.S.A.：Nova Science Publishers。 | | 3. | GAO(2009)。Pediatric Drug Research: Studies Conducted under Best Pharmaceuticals for Children Act。SAFETY EFFORTS IN PEDIATRIC DRUG DEVELOPMENT。U.S.A.：Nova Science Publishers。 | | 4. | Koski, Greg(2009)。Perspectives on Pediatric Clinical Trials: The Good, the Bad, and the Ugly。PEDIATRIC DRUG DEVELOPMENT。U.S.A.：John Wiley & Sons。 | | 5. | Milne, Christopher-Paul(2009)。Pharmaceutical Economics and Applications to Pediatrics: Business Case Pediatric Drug Development。PEDIATRIC DRUG DEVELOPMENT。U.S.A.：John Wiley & Sons。 | | 6. | Thaul, Susan(2010)。FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective。SAFETY EFFORTS IN PEDIATRIC DRUG DEVELOPMENT。U.S.A.：Nova Science Publishers。 | | 7. | Wright, Elisabeth Ann、Rose, Klaus(2010)。European Union Pediatric Regulation: Theory and Practice。GUIDE TO PEDIATRIC DRUG DEVELOPMENT AND CLINICAL RESEARCH。Karger：Switzerland。 | | 8. | 鄭中人(2009)。專利法規釋義。臺北：考用出版股份有限公司。 延伸查詢 | | 9. | 謝銘洋(2011)。智慧財產權法。臺北：元照出版社。 延伸查詢 | | 10. | 楊崇森(2007)。專利法理論與運用。台北：三民書局股份有限公司。 延伸查詢 | 其他| 1. | 內政部戶政司(2013)。民國102年3月戶口統計資料分析，http://www.moi.gov.tw/chi/chi_news/news_deail.aspx?sn=7274&type_code=01&search_k=%e6%88%b6%e5%8f%a3%e7%b5%b1%e8%a8%88%e8%b3%87%e6%96%99&pages=0， 2013/05/05。 | | 2. | 經濟部智慧財產局(2013)。專利審查基準彙編第二篇「發明專利實體審查」，第二章《何謂發明》暨第三章《專利要件》，http://www.IPO.gov.tw， 2013/03/10。 延伸查詢 | | 3. | 衛生署(2007)。提升兒童醫療品質之說明，http://www.mohw.gov.tw/CHT2006/DM/DM2_p01.aspx?class_no=0&now_fod_list_no=&level_no=&doc_no=52124， 2013/04/20。 | | 4. | 衛生署(2013)。兒童節給全國兒童的賀禮設立兒童醫院兒童醫療新紀元，http://www.doh.gov.tw/CHT2006/DM/DM2_p01.aspx?class_no=25&level_no=1&doc_no=88082， 2013/04/20。 延伸查詢 | | 5. | 醫療改革基金會(2006)。良藥不再難入口--小兒製劑父母心，http://www.thrf.org.tw/Page_Show.asp?Page_ID=352， 2013/04/27。 延伸查詢 | | 6. | 醫療改革基金會(2006)。兒童吃藥冒大險正視兒童藥劑的重要性，http://www.thrf.org.tw/Page_Show.asp?Page_ID=410， 2013/04/27。 延伸查詢 | | 7. | 醫療改革基金會(2007)。醫改會公佈：健保兒童專用藥至少102種--請家長先查詢，勇敢向醫師要求，拒絕再吃磨粉的大人藥，http://www.thrf.org.tw/Page_Show.asp?Page_ID =610， 2013/04/20。 延伸查詢 | | 8. | 醫療改革基金會(2008)。醫改會公布最新兒童用藥調查結果樂見臺灣兒童健康人權提昇，http://www.thrf.org.tw/Page_Show.asp?Page_ID=830， 2013/04/20。 延伸查詢 | | 9. | 醫療改革基金會(2011)。醫改會調查彙整現有兒童藥劑品項表，http://www.thrf.org.tw/child/word/05.xls， 2013/04/20。 延伸查詢 | | 10. | Arnum, Patricia Van(20110510)。PhRMA Urges Congress to Reauthorize Legislation for Pediatric Drugs，http://biopharminternational.findpharma.com/biopharm/News/PhRMA-Urges-Congress-to-Reauthorize-Legislation-fo/ArticleStandard/ Article/detail/721705， 2011/12/10。 | | 11. | Center Watch, Understanding Informed Consent，http://pediatrics.about.com/gi/o.htm?zi=1/XJ&zTi=1&sdn=pediatrics&cdn=health&tm=30&gps=120_281_1000_522&f=00&tt=14&bt=1&bts=1&zu=http%3A//www.centerwatch.com/patient/studies/area15.html， 2011/10/16。 | | 12. | Conger, Krista(2005)。What would Goldilocks do? When it comes to medicine for kids finding a dose that's just right is largely a matter of luck, Stanford Medicine Magazine，http://stanmed.stanford.edu/2005summer/kidsdrugs.html， 2011/06/13。 | | 13. | Drug Research and Children，http://www.fda.gov/Drugs/ResearchForYou/Consumers/ucm143565.htm， 2011/06/20。 | | 14. | Elizabeth's Story，http://www.pedaids.org/ElizabethsStory， 2011/06/13。 | | 15. | FDA(20130408)。Breakdown of FDAAA Completed Pediatric Studies Between Sept. 27, 2007 and April 5, 2013，http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Development Resources/ucm190622.htm， 2013/04/27。 | | 16. | FDA(1998)。Information Sheets Guidance for Institutional Review Boards and Clinical Investigators，http://www.fda.gov/oc/ohrt/irbs/toc4.html， 2011/11/05。 | | 17. | FDA(20080117)。Public Health Advisory: FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age，http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/rugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051137.htm， 2011/06/13。 | | 18. | GAO REPORT(201105)。Pediatric Research - Products Studied under Two Related Laws, But Improved (U.S.A.: GAO)，http://www.gao.gov/assets/320/319073.pdf， 2013/04/27。 | | 19. | Goodman, Jesse(20100721)。Rare and Neglected Pediatric Diseases, before Committee on Health, Education, Labor and Pensions, United States Senate，http://www.hhs.gov/asl/testify/2010/07/t20100721b.html， 2013/04/27。 | | 20. | (20070125)。Government tested AIDS drugs on foster kids，http://www.rinf.com/news/nov05/testedAIDS.html， 2011/10/15。 | | 21. | Gupta, Sanjay。Are Old Drugs Better than New?，http://www.time.com/time/magazome/article/0,9171,1002419,00.html， 2011/12/03。 | | 22. | Reinberg, Steven(20080328)。New Drugs No Better Than Older Ones for Schizophrenia，http://www.washingtonpost.com/wp-dyn/content/article/2008/03/28/AR2008032801723.html， 2011/12/03。 | | 23. | U.S. Census Bureau, Population by Sex and Selected Age Groups: 2000 and 2010，http://www.census.gov/prod/cen2010/briefs/c2010br-03.pdf， 2011/10/22。 | | 24. | (20080414)。University of Michigan C.S. Mott Children's Hospital, National Poll on Children's Health, Is My Child's Medicine FDA-Approved?，http://health.med.umich.edu/body.cfm?id=385， 2011/12/01。 | | 25. | Woodcock, Janet。Implementation of the Pediatric Exclusivity Provisions, the testimony before the Senate Committee on Health, Education, Labor, and Pensions，http://www.fda.gov/NewsEvents/Testimony/ucm115220.htm， 2011/12/10。 | |