siva vaithiyalingam phd vice president, regulatory … vaithiyalingam, phd, cipla ltd...
TRANSCRIPT
![Page 1: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins](https://reader031.vdocument.in/reader031/viewer/2022031808/5ab2c05a7f8b9ac3348d9fae/html5/thumbnails/1.jpg)
Siva Vaithiyalingam PhD Vice President, Regulatory Affairs
Cipla LTD
![Page 2: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins](https://reader031.vdocument.in/reader031/viewer/2022031808/5ab2c05a7f8b9ac3348d9fae/html5/thumbnails/2.jpg)
Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017
Proteins Peptides Opioids and Abuse Deterrent (AD):
![Page 3: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins](https://reader031.vdocument.in/reader031/viewer/2022031808/5ab2c05a7f8b9ac3348d9fae/html5/thumbnails/3.jpg)
Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017
Proteins Peptides Opioids and Abuse Deterrent (AD):
![Page 4: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins](https://reader031.vdocument.in/reader031/viewer/2022031808/5ab2c05a7f8b9ac3348d9fae/html5/thumbnails/4.jpg)
Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017
Partial AUC for Establishing Bio-Equivalence
![Page 5: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins](https://reader031.vdocument.in/reader031/viewer/2022031808/5ab2c05a7f8b9ac3348d9fae/html5/thumbnails/5.jpg)
Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017
BCS III Waiver:
![Page 6: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins](https://reader031.vdocument.in/reader031/viewer/2022031808/5ab2c05a7f8b9ac3348d9fae/html5/thumbnails/6.jpg)
Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017
BCS III Waiver:
![Page 7: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins](https://reader031.vdocument.in/reader031/viewer/2022031808/5ab2c05a7f8b9ac3348d9fae/html5/thumbnails/7.jpg)
Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017
NTI Drugs
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Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017
Thank You