What is difference between NDA & ANDA ?
NDA means New Drug Application,sponsor of new drug must submit evidence of drug safety&effectiveness to meet FDA requirements for marketing approval,hence sponsor submits to FDA a New Drug Application(NDA)......ANDA means Abbreviated New Drug Application which is an application for US generic drug approval for an existing licensed medication or approved drug.
Thanks,
B.Gangatharan,
Caplin Point laboratory,
Puducherry.
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what is stability study ? why it is needed and how itis done
i set electrode to 7 buffer than i used it to check 4 buffer and 10 buffer if the results are not as expected than is it better to set the buffer again to 4 buffer or is there any other method available please let me know ...
What is Band broading effect explain
In Analytical method development related substance method when did follow w/w method when did follow area normalisation method
2 Answers Dr Reddys, Sun Pharma,
What are the primary standards?
What are the tests used in Hplc?Name any two.
what is the most common FT-IR source used for the MID&Near IR regions?
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what is the difference between capillary and glass column in GC
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Why dissolution apparatus having 8 jars ?
How does GC did work?
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