際際滷shows by User: debangshuroy89 / http://www.slideshare.net/images/logo.gif 際際滷shows by User: debangshuroy89 / Thu, 12 Apr 2012 15:23:52 GMT 際際滷Share feed for 際際滷shows by User: debangshuroy89 ANDA filing /debangshuroy89/anda-filing-12518849 andafiling-120412152352-phpapp01
The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.]]>

The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.]]>
Thu, 12 Apr 2012 15:23:52 GMT /debangshuroy89/anda-filing-12518849 debangshuroy89@slideshare.net(debangshuroy89) ANDA filing debangshuroy89 The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/andafiling-120412152352-phpapp01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.
ANDA filing from debangshuroy89
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Anda filing /slideshow/anda-filing-12518733/12518733 andafiling-120412151250-phpapp02
The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with USFDA and other Regulatory bodies ]]>

The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with USFDA and other Regulatory bodies ]]>
Thu, 12 Apr 2012 15:12:49 GMT /slideshow/anda-filing-12518733/12518733 debangshuroy89@slideshare.net(debangshuroy89) Anda filing debangshuroy89 The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with USFDA and other Regulatory bodies <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/andafiling-120412151250-phpapp02-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with USFDA and other Regulatory bodies
Anda filing from debangshuroy89
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