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http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/81101完整後設資料紀錄
| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 陳建煒(Kin-Wei A. Chan) | |
| dc.contributor.author | I-Hsuan Chen | en |
| dc.contributor.author | 陳以瑄 | zh_TW |
| dc.date.accessioned | 2022-11-24T03:30:37Z | - |
| dc.date.available | 2021-10-01 | |
| dc.date.available | 2022-11-24T03:30:37Z | - |
| dc.date.copyright | 2021-10-01 | |
| dc.date.issued | 2021 | |
| dc.date.submitted | 2021-08-19 | |
| dc.identifier.citation | 1.Andrade SE, Raebel MA, Morse AN, et al. Use of prescription medications with a potential for fetal harm among pregnant women. Pharmacoepidemiol Drug Saf 2006;15:546-54. doi: 10.1002/pds.1235. 2.Lenz W, Knapp K. [Thalidomide embryopathy]. Dtsch Med Wochenschr 1962;87:1232-42. doi: 10.1055/s-0028-1111892. 3.Goodrich WW. FDA's Regulation under the Kefauver-Harris Drug Amendments of 1962. Food Drug Cosm LJ 1963;18:561. 4.Berglund F, Flodh H, Lundborg P, Prame B, Sannerstedt R. Drug use during pregnancy and breast-feeding. A classification system for drug information. Acta Obstet Gynecol Scand Suppl 1984;126:1-55. doi: 10.3109/00016348409156383. 5.Sannerstedt R, Lundborg P, Danielsson BR, et al. Drugs during pregnancy: an issue of risk classification and information to prescribers. Drug Saf 1996;14:69-77. doi: 10.2165/00002018-199614020-00001. 6.Pregnancy labeling. FDA Drug Bull 1979;9:23-4. 7.Pregnancy ADECWPoCoDi, Party ADECMiPW, Health ADo, Services F, Subcommittee ADECCA. Medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy: Australian Government Publishing Service, 1992. 8.Addis A, Sharabi S, Bonati M. Risk classification systems for drug use during pregnancy: are they a reliable source of information? Drug Saf 2000;23:245-53. doi: 10.2165/00002018-200023030-00006. 9.Boothby LA, Doering PL. FDA labeling system for drugs in pregnancy. Ann Pharmacother 2001;35:1485-9. doi: 10.1345/aph.1A034. 10.FDA classification of drugs for teratogenic risk. Teratology Society Public Affairs Committee. Teratology 1994;49:446-7. doi: 10.1002/tera.1420490603. 11.Feibus KB. FDA's proposed rule for pregnancy and lactation labeling: improving maternal child health through well-informed medicine use. 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The new FDA labeling rule: impact on prescribing rheumatological medications during pregnancy. Rheumatology (Oxford) 2018;57:v2-v8. doi: 10.1093/rheumatology/key010. 18.Beroukhim K, Abrouk M, Farahnik B. Impact of the Pregnancy and Lactation Labeling Rule (PLLR) on Practicing Dermatologists. Dermatol Online J 2015;21. 19.European Medicines Agency. Notice to Applicants. A guideline on Summary of Product Characteristics (SmPC). Available at: https://ec.europa.eu/health/documents/eudralex/vol-2_en. Accessed 23 May, 2021. 20.Arguello B, Salgado TM, Fernandez-Llimos F. Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation. Br J Clin Pharmacol 2015;79:537-44. doi: 10.1111/bcp.12515. 21.European Medicines Agency. EMA Regulatory Science to 2025 Strategic reflection. Available at: https://www.ema.europa.eu/en/about-us/how-we-work/regulatory-science-strategy#regulatory-science-strategy-to-2025-section. Accessed 23 May, 2021. 22.European Medicines Agency. Guideline on the exposure to medicinal products during pregnancy: need for post-authorisation data. Available at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-exposure-medicinal-products-during-pregnancy-need-post-authorisation-data_en.pdf. Accessed 23 May, 2021. 23.European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations III: Pregnant and breastfeeding women. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-product-population-specific-considerations-iii_en.pdf. Accessed 23 May 2021. 24.European Medicines Agency. Workshop on benefit-risk of medicines used during pregnancy and breastfeeding. Available at: https://www.ema.europa.eu/en/documents/report/report-workshop-benefit-risk-medicines-used-during-pregnancy-breastfeeding_en.pdf. Accessed 23 May, 2020. 25.Swissmedic. Pregnancy, obstetrics and lactation. Available at: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/fokusthemen/pregnancy-breastfeeding.html. Accessed June 14, 2021. 26.Medicines and Healthcare products Regulatory Agency. Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancy. Available at: https://www.gov.uk/drug-safety-update/medicines-in-pregnancy-and-breastfeeding-new-initiative-for-consistent-guidance-report-on-optimising-data-for-medicines-used-during-pregnancy#report-on-a-yellow-card. Accessed June 14, 2021. 27.Swiss Academy of Perinatal Pharmacology. Drugs in pregnancy and lactation. Available at: https://www.sappinfo.ch/en/. Accessed June 14, 2021. 28.Medicines and Healthcare products Regulatory Agency (MHRA). Safer Medicines in Pregnancy and Breastfeeding Consortium. Available at: https://www.gov.uk/government/publications/safer-medicines-in-pregnancy-and-breastfeeding-consortium. Accessed 13 June 2021. 29.Medicines and Healthcare products Regulatory Agency (MHRA). Use of medicines in pregnancy and breastfeeding. Available at: https://www.gov.uk/guidance/use-of-medicines-in-pregnancy-and-breastfeeding. Accessed June 13, 2021. 30.夏东胜. 我国药品说明书孕妇及哺乳期妇女用药标示问题分析及风险控制建议. 中国药物警戒 2015;12:211-8. 31.Song I, Choi SH, Shin JY. Trends in prescription of pregnancy-contraindicated drugs in Korea, 2007-2011. Regul Toxicol Pharmacol 2016;75:35-45. doi: 10.1016/j.yrtph.2015.12.011. 32.Japan Drug Information Institute in Pregnancy. Available at: https://www.ncchd.go.jp/en/center/activity/JDIIP/. Accessed 23 May, 2021. 33.Ministry of Health, Labor and Welfare. Pharmaceuticals and Medical Devices Safety Information (PMDSI) No. 355. Available at: https://www.pmda.go.jp/files/000225335.pdf. Accessed 23 May, 2021. 34.Noh Y, Yoon D, Song I, Jeong HE, Bae JH, Shin JY. Discrepancies in the Evidence and Recommendation Levels of Pregnancy Information in Prescription Drug Labeling in the United States, United Kingdom, Japan, and Korea. J Womens Health (Larchmt) 2018;27:1086-92. doi: 10.1089/jwh.2017.6792. 35.Warrer P, Aagaard L, Hansen EH. Comparison of pregnancy and lactation labeling for attention-deficit hyperactivity disorder drugs marketed in Australia, the USA, Denmark, and the UK. Drug Saf 2014;37:805-13. doi: 10.1007/s40264-014-0215-2. 36.US Department of Health and Human Services. Protection of human subjects 2009. Available at: https://www.hhs.gov/ohrp/sites/default/files/ohrp/humansubjects/regbook2013.pdf.pdf. Accessed 23 May, 2021. 37.ICH harmonised guideline. Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals S5(R3). Available at: https://www.ich.org/page/safety-guidelines. Accessed 24 May, 2021. 38.ICH harmonised guideline. Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1). Available at: https://www.ich.org/page/safety-guidelines. Accessed 24 May, 2021. 39.ICH harmonised guideline. Guidance in Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Available at: https://www.ich.org/page/multidisciplinary-guidelines. Accessed 24 May, 2021. 40.ICH harmonised guideline. Nonclinical Evaluation for Anticancer Pharmaceuticals. Available at: https://www.ich.org/page/safety-guidelines. Accessed 24 May, 2021. 41.US Food and Drug Administration. Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-pharmaceuticals-reproductive-toxicity-testing-and-labeling-recommendations-guidance. Accessed 24 May, 2021. 42.Barrow P, Clemann N. Review of embryo-fetal developmental toxicity studies performed for pharmaceuticals approved by FDA in 2018 and 2019. Reprod Toxicol 2021;99:144-51. doi: 10.1016/j.reprotox.2020.06.013. 43.Mosavati B, Oleinikov AV, Du E. Development of an Organ-on-a-Chip-Device for Study of Placental Pathologies. Int J Mol Sci 2020;21:8755. 44.U.S. Food and Drug Administration. Guidance for Industry on Establishing Pregnancy Exposure Registries. Available at: http://www.pregmedic.org/files/FDA_Guidance-Pregancy_Registries_Aug_2002.pdf. Accessed June 24, 2021. 45.Centers for Disease Control and Prevention. V-safe COVID-19 Vaccine Pregnancy Registry. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafepregnancyregistry.html. Accessed 24 May 2021. 46.FDA. Study Approaches and Methods To Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting; Public Meeting, Request for Comments. Available at: https://www.fda.gov/drugs/news-events-human-drugs/study-approaches-and-methods-evaluate-safety-drugs-and-biological-products-during-pregnancy-post?fbclid=IwAR0r6aJN6x-ONB3ea_FKhW8LrtiLOsMevW9xt4ACKRzue8gWolz1BPUCuCY. Accessed June 24, 2021. 47.Charlton R, de Vries C. Systematic overview of data sources for drug safety in pregnancy research Consultancy EMA/2010/29/CN. Available at: http://www.encepp.eu/structure/documents/Data_sources_for_medicines_in_pregnancy_research.pdf?fbclid=IwAR0O0Ioj8wUTXDBF6OHaQ1Xxyy7ArKP6tzjNDZvNb_lbsalbbaUjSeD0pfM. Accessed June 24, 2021. 48.Krueger WS, Anthony MS, Saltus CW, et al. Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and Data Sources in Multiple Sclerosis. Drugs Real World Outcomes 2017;4:139-49. doi: 10.1007/s40801-017-0114-9. 49.Sperling RS, Stratton P. Treatment options for human immunodeficiency virus-infected pregnant women. Obstetric-Gynecologic Working Group of the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases. Obstet Gynecol 1992;79:443-8. doi: 10.1097/00006250-199203000-00024. 50.Shields KE, Lyerly AD. Exclusion of pregnant women from industry-sponsored clinical trials. Obstet Gynecol 2013;122:1077-81. doi: 10.1097/AOG.0b013e3182a9ca67. 51.Scaffidi J, Mol BW, Keelan JA. The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy. BJOG 2017;124:132-40. doi: 10.1111/1471-0528.14151. 52.Bhattacharya S. Safe and Effective Medicines for Use in Pregnancy: A Call to Action. Available at: https://www.birminghamhealthpartners.co.uk/wp-content/uploads/2021/01/21560-Policy-Commission-Maternal-Health-Report-AW-accessible.pdf. Accessed June 24, 2021. 53.Smith DD, Pippen JL, Adesomo AA, Rood KM, Landon MB, Costantine MM. Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries. Am J Perinatol 2020;37:792-9. doi: 10.1055/s-0040-1712103. 54.Liu KA, Mager NA. Women's involvement in clinical trials: historical perspective and future implications. Pharm Pract (Granada) 2016;14:708. doi: 10.18549/PharmPract.2016.01.708. 55.U.S. Food and Drug Administration. Draft Guidance for Industry: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials. Available at: https://www.fda.gov/drugs/development-resources/division-pediatric-and-maternal-health-clinical-trials-pregnant-women. Accessed 25 May, 2021. 56.McKiever M, Frey H, Costantine MM. Challenges in conducting clinical research studies in pregnant women. J Pharmacokinet Pharmacodyn 2020;47:287-93. doi: 10.1007/s10928-020-09687-z. 57.Altman D, Carroli G, Duley L, et al. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet 2002;359:1877-90. doi: 10.1016/s0140-6736(02)08778-0. 58.Coomarasamy A, Devall AJ, Cheed V, et al. A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. N Engl J Med 2019;380:1815-24. doi: 10.1056/NEJMoa1813730. 59.Heyrana K, Byers HM, Stratton P. Increasing the Participation of Pregnant Women in Clinical Trials. JAMA 2018;320:2077-8. doi: 10.1001/jama.2018.17716. 60.Chatterjee S, Kotelchuck M, Sambamoorthi U. Prevalence of Chronic Illness in Pregnancy, Access to Care, and Health Care Costs: Implications for Interconception Care. Women's Health Issues 2008;18:S107-S16. doi: https://doi.org/10.1016/j.whi.2008.06.003. 61.14. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2020. Diabetes Care 2020;43:S183-s92. doi: 10.2337/dc20-S014. 62.Rowan JA, Hague WM, Gao W, Battin MR, Moore MP. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med 2008;358:2003-15. doi: 10.1056/NEJMoa0707193. 63.NICE guideline. Intrapartum care for women with existing medical conditions or obstetric complications and their babies. Available at: https://www.nice.org.uk/guidance/ng121/chapter/Recommendations#asthma. Accessed 25 May, 2021. 64.Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J 2020;55. doi: 10.1183/13993003.01208-2019. 65.BTS/SIGN British Guideline on the Management of Asthma. Available at: https://www.brit-thoracic.org.uk/quality-improvement/guidelines/asthma/. Accessed 25 May, 2021. 66.Chambers CD, Hernandez-Diaz S, Van Marter LJ, et al. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med 2006;354:579-87. doi: 10.1056/NEJMoa052744. 67.Yonkers KA, Wisner KL, Stewart DE, et al. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Gen Hosp Psychiatry 2009;31:403-13. doi: 10.1016/j.genhosppsych.2009.04.003. 68.National Institute for Health and Care Excellence (NICE). Antenatal and postnatal mental health: clinical management and service guidance. Available at: https://www.nice.org.uk/guidance/cg192. Accessed 25 May, 2021. 69.Chen YH, Chiou HY, Lin HC, Lin HL. Affect of seizures during gestation on pregnancy outcomes in women with epilepsy. Arch Neurol 2009;66:979-84. doi: 10.1001/archneurol.2009.142. 70.International League Against Epilepsy. Management of epilepsy in pregnancy. Available at: https://www.ilae.org/patient-care/epilepsy-and-pregnancy. Accessed 25 May, 2021. 71.National Institute for Health and Care Excellence (NICE). Epilepsies: diagnosis and management. 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Available at: https://www.rand.org/pubs/research_reports/RR4340.html. Accessed June 25, 2021. | |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/81101 | - |
| dc.description.abstract | 由於歷史因素，許多藥品並無充足的孕婦相關研究，藥品仿單的懷孕標示也十分模稜兩可，造成醫療專業人員及孕婦在面對藥物治療的問題時無依據可循。過去幾十年來，關於孕婦用藥安全議題的觀念已有所轉變，各國監管機構紛紛建立相關準則及政策，一方面鼓勵孕婦藥物相關研究的進行，以收集更多的證據來支持監管機關對於藥物致畸胎風險的決策，一方面藉由建立清楚明確且詳細的藥品標示，優化醫療專業人員和孕婦的醫療決策溝通。本文將回顧藥品懷孕分級制度的歷史沿革，比較新舊制度之差異及問題，了解各國現行孕婦用藥相關政策，分析不同的證據類型，並統整重要治療指引對孕婦慢性病用藥的建議，從法規、學術、臨床應用等面向探討此議題，我們了解到跨專業合作的重要性，以及透過創新技術及研究方法的開發來解決這長期存在的挑戰。 | zh_TW |
| dc.description.provenance | Made available in DSpace on 2022-11-24T03:30:37Z (GMT). No. of bitstreams: 1 U0001-1808202113141200.pdf: 2979730 bytes, checksum: a15fc7b3b9d31a31d2c5e4a4e6268010 (MD5) Previous issue date: 2021 | en |
| dc.description.tableofcontents | "論文口試委員審定書 i 誌謝 ii 中文摘要 iii 英文摘要 iv Contents 1 List of Figures and Tables 2 Chapter1. Introduction 3 1.1 Practicum Unit Features and Brief Introduction 3 1.2 Research Purpose and Research Problems 4 Chapter2. A Historical Perspective on Current Policies in Various Countries 6 2.1 Early History and US 6 2.1.1 Early Classification Systems in Sweden, US, and Australia 6 2.1.2 The Difference between The Three Systems and Their Limitations 7 2.2 The Evolution of Revolution: FDA’s New Pregnancy and Labeling Rule 8 2.2.1 Changes of the New Labeling Policy 8 2.2.2 Challenges and Implementations of Pregnancy and Lactation Labeling Rule 9 2.3 Europe, Early and More Recent Policies 10 2.4 China, Korea and Japan 11 Chapter3. Evidence to Support Drug Label 13 3.1 Animal Studies 13 3.2 Observational Studies and Pregnancy Registries 14 3.3 Clinical Trials 16 Chapter4. Management for Chronic Diseases during Pregnancy 21 4.1 Overview 21 4.2 Diabetes 22 4.3 Asthma 22 4.4 Depression 23 4.5 Epilepsy 23 Chapter5. Discussion 25 Chapter6. Conclusion 27 References 28 Appendix 37" | |
| dc.language.iso | en | |
| dc.subject | 臨床試驗 | zh_TW |
| dc.subject | 孕婦 | zh_TW |
| dc.subject | 用藥安全 | zh_TW |
| dc.subject | 藥品懷孕標示 | zh_TW |
| dc.subject | 懷孕用藥分級 | zh_TW |
| dc.subject | 慢性病 | zh_TW |
| dc.subject | chronic diseases | en |
| dc.subject | medication safety | en |
| dc.subject | clinical trials | en |
| dc.subject | Pregnant women | en |
| dc.subject | pregnancy classification | en |
| dc.subject | drug labeling | en |
| dc.title | 以孕婦用藥之實證評估支持監管決策 | zh_TW |
| dc.title | Evidence-based Evaluation of Medication Use in Pregnancy to Support Regulatory Decision | en |
| dc.date.schoolyear | 109-2 | |
| dc.description.degree | 碩士 | |
| dc.contributor.coadvisor | 陳秀熙(Hsiu-His Chen) | |
| dc.contributor.oralexamcommittee | 王知行(Hsin-Tsai Liu),(Chih-Yang Tseng) | |
| dc.subject.keyword | 孕婦,用藥安全,藥品懷孕標示,懷孕用藥分級,慢性病,臨床試驗, | zh_TW |
| dc.subject.keyword | Pregnant women,medication safety,drug labeling,pregnancy classification,chronic diseases,clinical trials, | en |
| dc.relation.page | 37 | |
| dc.identifier.doi | 10.6342/NTU202102464 | |
| dc.rights.note | 同意授權(限校園內公開) | |
| dc.date.accepted | 2021-08-20 | |
| dc.contributor.author-college | 公共衛生學院 | zh_TW |
| dc.contributor.author-dept | 公共衛生碩士學位學程 | zh_TW |
| 顯示於系所單位： | 公共衛生碩士學位學程 | |
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| U0001-1808202113141200.pdf 授權僅限NTU校內IP使用（校園外請利用VPN校外連線服務） | 2.91 MB | Adobe PDF |
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