Vol 12 No 3 (2024): VOLUME 12, ISSUE 3, 2024 | International Journal of Drug Regulatory Affairs

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href="https://www.ijdra.com/index.php/journal/index"> Home </a> <span class="separator">/</span> </li> <li> <a href="https://www.ijdra.com/index.php/journal/issue/archive"> Archives </a> <span class="separator">/</span> </li> <li class="current"> <h1> Vol 12 No 3 (2024): VOLUME 12, ISSUE 3, 2024 </h1> </li> </ol> </nav> <div class="obj_issue_toc"> <div class="heading"> </div> <div class="sections"> <div class="section"> <h2> Research </h2> <ul class="cmp_article_list articles"> <li> <div class="obj_article_summary"> <div class="title"> <a href="https://www.ijdra.com/index.php/journal/article/view/666"> The Co-Sponsor in the conduct of a Clinical Trial in Germany </a> </div> <div class="meta"> <div class="authors"> Raees Ahmed, Simge S眉ng眉, Christoph Gerst </div> <div class="pages"> Pages 1-4 </div> </div> <ul class="galleys_links"> <li> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/view/666/370" target="_blank"> View pdf </a> <a class="obj_galley_link" href='https://www.ijdra.com/index.php/journal/article/view/666'> Abstract </a> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/download/666/370"> Download pdf </a> DOI <a href="https://doi.org/10.22270/ijdra.v12i3.666"> 10.22270/ijdra.v12i3.666 </a> </li> </ul> </div> </li> </ul> </div> <div class="section"> <h2> Review </h2> <ul class="cmp_article_list articles"> <li> <div class="obj_article_summary"> <div class="title"> <a href="https://www.ijdra.com/index.php/journal/article/view/680"> Post-approval changes in Labelling regulations in the United States, European Union and Canada </a> </div> <div class="meta"> <div class="authors"> Yash Shegokar, Sakshi Dhawad, Vinita Kale, Suankit Harane, Milind Umekar </div> <div class="pages"> Pages 5-12 </div> </div> <ul class="galleys_links"> <li> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/view/680/373" target="_blank"> View pdf </a> <a class="obj_galley_link" href='https://www.ijdra.com/index.php/journal/article/view/680'> Abstract </a> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/download/680/373"> Download pdf </a> DOI <a href="https://doi.org/10.22270/ijdra.v12i3.680"> 10.22270/ijdra.v12i3.680 </a> </li> </ul> </div> </li> <li> <div class="obj_article_summary"> <div class="title"> <a href="https://www.ijdra.com/index.php/journal/article/view/684"> Medical Foods for the management of Chronic Illness and their Regulations in India, US and European Union </a> </div> <div class="meta"> <div class="authors"> Trapti Saxena, Sruthi Yadala, Ausali Kavya Sri, Pishati Manasa Reddy, Monika Nijhawan </div> <div class="pages"> Pages 13-22 </div> </div> <ul class="galleys_links"> <li> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/view/684/371" target="_blank"> View pdf </a> <a class="obj_galley_link" href='https://www.ijdra.com/index.php/journal/article/view/684'> Abstract </a> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/download/684/371"> Download pdf </a> DOI <a href="https://doi.org/10.22270/ijdra.v12i3.684"> 10.22270/ijdra.v12i3.684 </a> </li> </ul> </div> </li> <li> <div class="obj_article_summary"> <div class="title"> <a href="https://www.ijdra.com/index.php/journal/article/view/687"> Comparative evaluation of Food for Special Dietary Use (FSDU) and Food for Special Medical Purpose (FSMP) product regulatory framework in India, EU and US </a> </div> <div class="meta"> <div class="authors"> Aashvi Patel, Maitreyi Zaveri, Vishal Dubey, Dharmesh Kheni, Niranjan Kanaki </div> <div class="pages"> Pages 23-31 </div> </div> <ul class="galleys_links"> <li> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/view/687/372" target="_blank"> View pdf </a> <a class="obj_galley_link" href='https://www.ijdra.com/index.php/journal/article/view/687'> Abstract </a> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/download/687/372"> Download pdf </a> DOI <a href="https://doi.org/10.22270/ijdra.v12i3.687"> 10.22270/ijdra.v12i3.687 </a> </li> </ul> </div> </li> <li> <div class="obj_article_summary"> <div class="title"> <a href="https://www.ijdra.com/index.php/journal/article/view/691"> A Review on a Drug Registration Process in United Kingdom </a> </div> <div class="meta"> <div class="authors"> Yash B. Kulkarni, Lokesh P. Kothari </div> <div class="pages"> Pages 32-37 </div> </div> <ul class="galleys_links"> <li> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/view/691/369" target="_blank"> View pdf </a> <a class="obj_galley_link" href='https://www.ijdra.com/index.php/journal/article/view/691'> Abstract </a> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/download/691/369"> Download pdf </a> DOI <a href="https://doi.org/10.22270/ijdra.v12i3.691"> 10.22270/ijdra.v12i3.691 </a> </li> </ul> </div> </li> <li> <div class="obj_article_summary"> <div class="title"> <a href="https://www.ijdra.com/index.php/journal/article/view/692"> Regulatory Development, Adoption, and Perseverance of Real-world Evidence with global health authorities </a> </div> <div class="meta"> <div class="authors"> Sanyam Gandhi, Kinshuk Saxena, C Kartikeyan, Akhilesh Tiwari, Sachin Jain, Vikas Jain, Pradeep Pal </div> <div class="pages"> Pages 38-46 </div> </div> <ul class="galleys_links"> <li> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/view/692/374" target="_blank"> View pdf </a> <a class="obj_galley_link" href='https://www.ijdra.com/index.php/journal/article/view/692'> Abstract </a> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/download/692/374"> Download pdf </a> DOI <a href="https://doi.org/10.22270/ijdra.v12i3.692"> 10.22270/ijdra.v12i3.692 </a> </li> </ul> </div> </li> <li> <div class="obj_article_summary"> <div class="title"> <a href="https://www.ijdra.com/index.php/journal/article/view/693"> Lifecycle Management of Generic product in US market </a> </div> <div class="meta"> <div class="authors"> Sakshi Dhawad, Samiksha Dhote, Yash Shegokar, Vinita Kale, Milind Umekar </div> <div class="pages"> Pages 47-54 </div> </div> <ul class="galleys_links"> <li> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/view/693/375" target="_blank"> View pdf </a> <a class="obj_galley_link" href='https://www.ijdra.com/index.php/journal/article/view/693'> Abstract </a> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/download/693/375"> Download pdf </a> DOI <a href="https://doi.org/10.22270/ijdra.v12i3.693"> 10.22270/ijdra.v12i3.693 </a> </li> </ul> </div> </li> <li> <div class="obj_article_summary"> <div class="title"> <a href="https://www.ijdra.com/index.php/journal/article/view/699"> Index of application status transparency and availability of public information for Project Orbis agencies </a> </div> <div class="meta"> <div class="authors"> Sso H. Lee, Lauren T. Hotaki, Kukhwa Oh, Jessica Samuel, Krystal de Villiers, Kirubel Eshetie, Yee H. Looi, Eiman Atiek, Fanny Cudre-Mauroux, Ulrich-Peter Rohr, Graham Searle, Lenardo N. Santos, Silmara C. da. S. Andreoli, Yoko Aoi, Masakazu Hirata, Caroline Voltz-Girolt, Carlos Aicardo, Callan Cain, Tal Naggan, Anat Boehm-Cagan, Michal Hirsch-Vexberg, Osnat Luxenburg, Nabbiya Ahmed, Laura Johnson, Melissa Hunt, Duc Vu, Marc R. Theoret, Dianne Spillman, R. Angelo de Claro </div> <div class="pages"> Pages 55-65 </div> </div> <ul class="galleys_links"> <li> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/view/699/378" target="_blank"> View pdf </a> <a class="obj_galley_link" href='https://www.ijdra.com/index.php/journal/article/view/699'> Abstract </a> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/download/699/378"> Download pdf </a> DOI <a href="https://doi.org/10.22270/ijdra.v12i3.699"> 10.22270/ijdra.v12i3.699 </a> </li> </ul> </div> </li> <li> <div class="obj_article_summary"> <div class="title"> <a href="https://www.ijdra.com/index.php/journal/article/view/704"> Navigating Regulatory requirements for Stem Cells Therapy- A review on Regulations of US, European Union, Japan and India </a> </div> <div class="meta"> <div class="authors"> Aishwarya M. Khabade, Shruti S. Agarwal, Harshali B. Mahajan, Satish K. Mandlik </div> <div class="pages"> Pages 66-81 </div> </div> <ul class="galleys_links"> <li> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/view/704/376" target="_blank"> View pdf </a> <a class="obj_galley_link" href='https://www.ijdra.com/index.php/journal/article/view/704'> Abstract </a> <a class="obj_galley_link pdf" href="https://www.ijdra.com/index.php/journal/article/download/704/376"> Download pdf </a> DOI <a href="https://doi.org/10.22270/ijdra.v12i3.704"> 10.22270/ijdra.v12i3.704 </a> </li> </ul> </div> </li> </ul> </div> </div> </div> </div> </div> <div class="pkp_structure_sidebar left" role="complementary" aria-label="Sidebar"> <div class="pkp_block block_make_submission"> <div class="content"> <a class="block_make_submission_link" href="https://www.ijdra.com/index.php/journal/about/submissions"> Make a Submission </a> <br><br> <a class="block_make_submission_link" href="https://www.ijdra.com/index.php/journal/subscription">    Subscription   </a> </div> </div> <div class="pkp_block block_custom" id="customblock-ojhome"> <div class="content"> <p align="center"><img src="/public/site/images/ijdra/ijdra-home11.jpg"><br><strong>Online ISSN: 2321-6794</strong><br><strong>Print ISSN: 2321-7162<br>CODEN (CAS-USA): IJDRAF</strong><br><br><img src="/public/site/images/ijdra/crossref.png"><br><img src="/public/site/images/ijdra/open-access12.png"><br><img src="/public/site/images/ijdra/qr.png"><br><strong>IJDRA QR CODE</strong></p> <p align="center"><img src="/public/site/images/ijdra/ijdra_payment.jpg"></p> </div> </div> <div class="pkp_block block_custom" id="customblock-translate"> <div class="content"> <div id="google_translate_element" align="center"> </div> </div> </div> <div class="pkp_block block_developed_by"> <div class="content"> <span style="font-size: 18px; font-weight: bold; background-color: #000; color: #fff; letter-spacing: 2px; padding:10px; line-height:75px">Visitor No. <script type="text/javascript" language="Javascript" src="/counter/counter.php?log=ijdra"></script> </span> </div> </div> </div> </div> <div id="pkp_content_footer" class="pkp_structure_footer_wrapper" role="contentinfo"> <div class="pkp_structure_footer"> <div class="pkp_footer_content"> <div class="footer_menu" align="center"><a href="https://ijdra.com/index.php/journal/journal-policy#plagiarism" target="_blank" rel="noopener">Plagiarism Policy</a> || <a href="https://ijdra.com/index.php/journal/contact">Contact Us</a></div> <div class="footer_menu" align="center"><a href="http://www.alibrarydirectory.com/">Libraries Resource Directory</a>. 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Vol 12 No 3 (2024): VOLUME 12, ISSUE 3, 2024 | International Journal of Drug Regulatory Affairs