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Audits of clinical trials in India: a step in the right direction. 印度临床试验审计:朝着正确方向迈出的一步。
The journal of biolaw & business Pub Date : 2006-01-01
Viveka Roychowdhury
{"title":"Audits of clinical trials in India: a step in the right direction.","authors":"Viveka Roychowdhury","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Random audits of clinical trial sites in India are due to start any time now. These regulatory measures come at a very crucial time when India's relatively young clinical research industry is poised for exponential growth. Can the industry scale up fast enough? Viveka Roychowdhury spoke to a cross section of industry experts to get their views.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 3","pages":"26-8"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26428517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ethical questions to ponder in the European stem cell patent debate. 欧洲干细胞专利辩论中需要思考的伦理问题。
The journal of biolaw & business Pub Date : 2006-01-01
Duncan Curley, Andrew Sharples
{"title":"Ethical questions to ponder in the European stem cell patent debate.","authors":"Duncan Curley,&nbsp;Andrew Sharples","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Patents may be refused in Europe on ethical grounds. Whereas in the past this issue has arisen only infrequently, recent developments in human embryonic stem cell research have given rise to conflicting opinions in Europe as to the approach that should be adopted in relation to patents. The United Kingdom Patent Office has adopted a positive policy towards inventions involving human embryonic stem cells, but the European Patent Office has to date refused to grant patent applications involving similar subject-matter. A series of legal questions on the role of ethics in granting European patents is now to be considered for clarification by the European Patent Office. The answers to these questions should eventually resolve the debate on the patenting of human embryonic stem cells throughout Europe.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 3","pages":"12-6"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26428515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Good clinical practice (GCP) standards: clinical trials in India. An interview with Dr. Urmila Thatte, Head of Clinical Pharmacology, TN Medical College & BYL Nair Hospital. Interview by Viveka Roychowdhury. 良好临床实践(GCP)标准:印度的临床试验。采访TN医学院和BYL Nair医院临床药理学主任Urmila Thatte博士。Viveka Roychowdhury采访。
The journal of biolaw & business Pub Date : 2006-01-01
Urmila Thatte
{"title":"Good clinical practice (GCP) standards: clinical trials in India. An interview with Dr. Urmila Thatte, Head of Clinical Pharmacology, TN Medical College & BYL Nair Hospital. Interview by Viveka Roychowdhury.","authors":"Urmila Thatte","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Dr. Urmila Thatte, Head of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai serves on several medical ethics committees. Viveka Roychowdhury interviews Dr. Thatte to get her views on the importance of ethics and adherence to Good Clinical Practice (GCP) standards.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 3","pages":"30-1"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26428519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Regulations limiting medical research in prisons remains necessary. 限制在监狱进行医学研究的条例仍然是必要的。
The journal of biolaw & business Pub Date : 2005-01-01
Alisa L Geller
{"title":"Regulations limiting medical research in prisons remains necessary.","authors":"Alisa L Geller","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Protection of human subjects against medical research in prisons remains appropriate.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 4","pages":"72-3"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25977721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Stem cell research in Canada: business opportunities for U.S. companies. 加拿大干细胞研究:美国公司的商机。
The journal of biolaw & business Pub Date : 2005-01-01
Cheryl Reicin, Eileen McMahon
{"title":"Stem cell research in Canada: business opportunities for U.S. companies.","authors":"Cheryl Reicin,&nbsp;Eileen McMahon","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The ban on the use of United States (U.S.) federal funds to support new embryonic stem cell research has had a chilling effect on such research in the U.S. In Canada, significant research opportunities are available for conducting stem cell research. The opportunities include using embryos that were originally produced for reproductive purposes, and using stem cells derived from adults and animals. Stem cell research in Canada is made even more attractive in view of the availability and quality of research facilities, the lower cost of conducting research in Canada than in the U.S., and the government tax credits.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 1","pages":"61-4"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25906661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
California makes unprecedented commitment to fund stem cell research. 加州对资助干细胞研究做出了前所未有的承诺。
The journal of biolaw & business Pub Date : 2005-01-01
Laura A Willard
{"title":"California makes unprecedented commitment to fund stem cell research.","authors":"Laura A Willard","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>California voters commit $3 billion over the next ten years to stem cell research.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 2","pages":"47-8"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25907224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Conflicts of interest in medical research: how much conflict should exceed legal boundaries? 医学研究中的利益冲突:多大程度的冲突应该超越法律界限?
The journal of biolaw & business Pub Date : 2005-01-01
Kaley Klanica
{"title":"Conflicts of interest in medical research: how much conflict should exceed legal boundaries?","authors":"Kaley Klanica","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article addresses the current plague of financially conflicted research from various perspectives including the research community, the medical community, patients/subjects, the Food and Drug Administration (F.D.A.), and other government agencies. Part one lays out the current conflicts of interest within medical research. Part two explains the actual and potential effects of these conflicts, highlighting the conflict of interest associated with the death of Jesse Gelsinger. Part three describes how conflicts of interest are currently regulated by government agencies and within individual institutions. Lastly, part four concludes by recommending a system of seven balanced reform measures that protect research subjects and the scientific integrity of medical research while encouraging scientific progress.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 3","pages":"37-45"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25839802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The impact of the HIPAA Privacy Rule on research participation. HIPAA隐私权规则对研究参与的影响。
The journal of biolaw & business Pub Date : 2005-01-01
Arlene D Luu
{"title":"The impact of the HIPAA Privacy Rule on research participation.","authors":"Arlene D Luu","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>HIPAA Privacy Rule significantly reduces the number of participants in research.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 4","pages":"68-9"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25977719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Judge declares pre-embryo is human. 法官宣布胚胎前为人类。
The journal of biolaw & business Pub Date : 2005-01-01
Katherine Vick
{"title":"Judge declares pre-embryo is human.","authors":"Katherine Vick","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 3","pages":"52-3"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25839803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
International stem cell use and regulation in research. 国际干细胞在研究中的应用和调控。
The journal of biolaw & business Pub Date : 2005-01-01
Laura Lin
{"title":"International stem cell use and regulation in research.","authors":"Laura Lin","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>International rules have broadened permitted use of stem cells.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 1","pages":"47-8"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25906660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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