{"product_id":"clinical-research-regulations-prof-rajiv-dahiya-9798895880951","title":"Clinical Research Regulations: Principles, Practices, and Global Perspectives","description":"\u003cp\u003eExplore the complexities of clinical research regulations in this comprehensive volume, \u003cstrong\u003eClinical Research Regulations: Principles, Practices, and Global Perspectives. Edited by Prof. Rajiv Dahiya and authored by Dr. Muralidhar Rao\u003c\/strong\u003e, this book offers an in-depth look at the\u003cstrong\u003e legal and ethical frameworks governing clinical trials across the globe.\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e \u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eSpanning 25 chapters, \u003c\/strong\u003e the book covers essential topics including\u003cstrong\u003e phases of clinical trials, ethical considerations, and global regulatory standards.\u003c\/strong\u003e It provides a structured approach, making it a go-to reference for pharmacists, researchers, and regulatory professionals.\u003c\/p\u003e\u003cp\u003eThis guide emphasizes international guidelines, ensuring readers stay informed about \u003cstrong\u003ethe FDA, EMA, and ICH-GCP regulations. It also addresses\u003c\/strong\u003e emerging trends in medical device investigations and biostatistical applications, making it a must-read for those involved in the clinical research process.\u003c\/p\u003e\u003cp\u003eThis text is a valuable resource for anyone looking to stay abreast of the evolving landscape of \u003cstrong\u003eclinical trials and global harmonization\u003c\/strong\u003e efforts in \u003cstrong\u003eclinical research\u003c\/strong\u003e.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eKey Features: \u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003ePhases 0-IV of Clinical Trials\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eGlobal Regulatory Standards (India, USA, EU)\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eEthics in Clinical Research\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eMedical Device Clinical Investigations\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eComprehensive Biostatistics for Clinical Research\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eInformed Consent Process \u0026amp; Documentation\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eRole of Institutional Review Boards (IRBs) and Data Safety Monitoring Boards (DSMBs).\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Prof Rajiv Dahiya,Dr Muralidhar Rao Akkaladevi\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798895880951\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Notion Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 10\/07\/2024\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 256\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.76lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.70d","brand":"Prof Rajiv Dahiya","offers":[{"title":"Paperback","offer_id":48446896472319,"sku":"9798895880951","price":24.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_a23dc4bf-35c3-42e6-8898-16f2b9b75ab4.jpg?v=1777227453","url":"https:\/\/www.whiterainbookhouse.com\/products\/clinical-research-regulations-prof-rajiv-dahiya-9798895880951","provider":"WR Book House","version":"1.0","type":"link"}