{"id":1966,"date":"2016-08-06T18:53:30","date_gmt":"2016-08-06T18:53:30","guid":{"rendered":"http:\/\/www.inspirenignite.com\/jntuk\/?p=1966"},"modified":"2016-08-06T18:53:30","modified_gmt":"2016-08-06T18:53:30","slug":"jntuk-b-tech-regulatory-affairs-ipr-patents-for-r13-batch","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/jntuk\/jntuk-b-tech-regulatory-affairs-ipr-patents-for-r13-batch\/","title":{"rendered":"JNTUK B. Tech Regulatory Affairs, IPR &amp; Patents for R13 Batch."},"content":{"rendered":"<p>JNTUK B.Tech Regulatory Affairs, IPR &amp; Patents gives you detail information of Regulatory Affairs, IPR &amp; Patents R13 syllabus It will be help full to understand you complete curriculum of the year.<\/p><div class=\"a9916ad81d5189659b0bfae0b37c143c\" data-index=\"1\" style=\"float: none; margin:10px 0 10px 0; text-align:center;\">\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block; text-align:center;\"\r\n     data-ad-layout=\"in-article\"\r\n     data-ad-format=\"fluid\"\r\n     data-ad-client=\"ca-pub-1181153414625576\"\r\n     data-ad-slot=\"9648548092\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\n<\/div>\n\n<p><strong>Unit-I : Preformulations and Formulation Development<\/strong> \u2013 Regulatory requirements in Preformulations and Formulation Development of Solid, liquid and Semisolid dosage.<\/p>\n<p><strong>LO :<\/strong> To understand preformulations \u2013 protocols \u2013 regulatory \u2013 requirements \u2013 Formulation Development of Solid, liquid and Semisolid dosage.<\/p>\n<p><strong>Unit-II : Manufacturing-<\/strong> Regulatory requirements related to manufacturing-manufacturing formula,Records, Validations involved-GMP Validations: Types- Validation of Process and Equipment \u2013 Raw materials, Excipients and solvents.<\/p>\n<p><strong>LO :<\/strong> To understand regulatory requirements related to manufacturing, validation \u2013 types, Validation of process, equipment, raw materials, excipients.<\/p>\n<p><strong>Unit-III : Regulatory requirements of packaging materials<\/strong>&#8211; Evaluation of Packaging materials.\u00a0Stability \u2013 Regulation for Stability testing of API, Solid and liquid dosage form as per ICH guidelines.<\/p>\n<p><strong>LO<\/strong> : To understand regulatory requirements of packaging materials, evaluation of packaging materials, stability testing as per ICH.<\/p>\n<p><strong>Unit \u2013 IV : Clinical Trials<\/strong> : Phase \u2013I, II, III &amp; IV studies \u2013 Regulations involved<\/p>\n<p><strong>LO :<\/strong> To understand regulatory requirements of Clinical Trials, Phase \u2013I, II, III &amp; IV studies.<\/p>\n<p><strong>Unit- V : A Study of Intellectual Property Rights<\/strong> : Definitions \u2013 Guidelines \u2013 National and international \u2013 Examples.<\/p>\n<p><strong>LO :<\/strong> To understand IPR with examples .<\/p>\n<p><strong>Unit- VI : Patents:<\/strong> patenting laws and Regulations \u2013 Procedures for obtaining and writing a patent \u2013 Examples.<\/p>\n<p><strong>LO :<\/strong> To understand patents, patent laws, procedures with examples.<\/p>\n<p><strong>References<\/strong><\/p>\n<ul>\n<li>Quality Assurance guide by organization of Pharmaceutical Procedures of India<\/li>\n<li>Drug formulation manual by D.P.S.Kohli and D.H.Shah. Eastern Publishers, New Delhi.<\/li>\n<li>How to Practice GMPs By P.P.Sharma, Vandhana Publications, Agra.<\/li>\n<li>Pharmaceutical Process Validation by FRA.R.Berry and Robert.A.Nash.<\/li>\n<li>Pharmaceutical Preformulations by J.J.Wells.<\/li>\n<li>Applied Production and Operations management by Evans, Anderson, Sweeny and Williams.<\/li>\n<li>Basic principles of Clinical Research and methodology by Guptha.<\/li>\n<li>Biopharmaceutics and Clinical Pharmacokinetics \u2013 An Introduction ; 4th Edition, Revised and Expanded by Robert E. Notary, Marcel Dekker incm, New york and Basel, 1987.<\/li>\n<\/ul>\n<p>For more information about all JNTU updates please stay connected to us on FB and don\u2019t hesitate to ask any questions in the comment.<\/p>\n<div class=\"a9916ad81d5189659b0bfae0b37c143c\" data-index=\"2\" style=\"float: none; margin:10px 0 10px 0; text-align:center;\">\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block; text-align:center;\"\r\n     data-ad-layout=\"in-article\"\r\n     data-ad-format=\"fluid\"\r\n     data-ad-client=\"ca-pub-1181153414625576\"\r\n     data-ad-slot=\"8060844699\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\n<\/div>\n\n<div style=\"font-size: 0px; height: 0px; line-height: 0px; margin: 0; padding: 0; clear: both;\"><\/div>","protected":false},"excerpt":{"rendered":"<p>JNTUK B.Tech Regulatory Affairs, IPR &amp; Patents gives you detail information of Regulatory Affairs, IPR &amp; Patents R13 syllabus It will be help full to understand you complete curriculum of [&hellip;]<\/p>\n","protected":false},"author":2259,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-1966","post","type-post","status-publish","format-standard","hentry","category-syllabus"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/posts\/1966","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/users\/2259"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/comments?post=1966"}],"version-history":[{"count":1,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/posts\/1966\/revisions"}],"predecessor-version":[{"id":1967,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/posts\/1966\/revisions\/1967"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/media?parent=1966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/categories?post=1966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/tags?post=1966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}