{"title":"Pharmaceutical regulatory requirements of nonregulated markets","authors":"G. Ganesh, S. Mohankumar","doi":"10.1016/b978-0-12-822211-9.00002-2","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00002-2","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127577580","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}
S. Lodha, Hetal Patel, Shrikant Joshi, Gajanan G Kalyankar, A. Mishra
{"title":"Regulatory requirements of regulated market","authors":"S. Lodha, Hetal Patel, Shrikant Joshi, Gajanan G Kalyankar, A. Mishra","doi":"10.1016/b978-0-12-822211-9.00004-6","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00004-6","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122466757","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}
{"title":"Regulatory requirement for the approval of novel, nanotechnology-based biological products","authors":"Shobhit Kumar, J. Ali, S. Baboota","doi":"10.1016/b978-0-12-822211-9.00009-5","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00009-5","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"139 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123252837","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}
{"title":"International Council for Harmonisation (ICH) guidelines","authors":"Bhavna, A. Ojha, Samir Bhargava","doi":"10.1016/b978-0-12-822211-9.00008-3","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00008-3","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114663909","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}
{"title":"Regulatory affairs in clinical trials","authors":"M. Khan, Sadat Shafi, Syed Sufian Ahmad, F. Ahmed","doi":"10.1016/b978-0-12-822211-9.00006-x","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00006-x","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"74 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129750037","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}
{"title":"Dedication","authors":"","doi":"10.1016/b978-0-12-822211-9.00007-1","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00007-1","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121236184","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}
{"title":"Global submissions for drug approvals","authors":"Shrestha Sharma, S. Rabbani, R. Sharma","doi":"10.1016/b978-0-12-822211-9.00005-8","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00005-8","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128354659","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}
G. Mustafa, Md. Ali Mujtaba, S. Kotta, Abdullah Habeeballah, N. Alhakamy, H. Aldawsari, Shahid Karim, Shadab Md
{"title":"Drug product performance and scale-up process approval changes","authors":"G. Mustafa, Md. Ali Mujtaba, S. Kotta, Abdullah Habeeballah, N. Alhakamy, H. Aldawsari, Shahid Karim, Shadab Md","doi":"10.1016/b978-0-12-822211-9.00010-1","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00010-1","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"108 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127938642","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}
{"title":"Regulatory affairs for chemistry, manufacturing, and controls","authors":"Sonal Gupta, S. Baboota, J. Ali, S. Dang","doi":"10.1016/b978-0-12-822211-9.00003-4","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00003-4","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126575549","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}
J. Narang, Anmol Dogra, J. Ali, S. Baboota, Harmanpreet Singh
{"title":"Drug regulatory affairs: an introduction","authors":"J. Narang, Anmol Dogra, J. Ali, S. Baboota, Harmanpreet Singh","doi":"10.1016/b978-0-12-822211-9.00001-0","DOIUrl":"https://doi.org/10.1016/b978-0-12-822211-9.00001-0","url":null,"abstract":"","PeriodicalId":427532,"journal":{"name":"Regulatory Affairs in the Pharmaceutical Industry","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134296487","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}