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.
Caplin Point laboratory,
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In which situation we require to prepare the standard solution from sample in Related substance method?
formula for %RSD.
Whatn is HPLC
Why the ph limit (1_14) Is used?
about method developement in hplc
in uv visible spectroscopy calibration why we are using potasium dichromate and tolune
if you get peak in blank then what require to do?
What is the difference between GSC & GLC?
how do start hplc method development? how much sample required for developing the method development?
In GC calibration,what is the procedure to calibrate the TCD (thermal counductivity detector)suggest ?
if the purity is 99.9%,is need to do assay?
why we are using only lead standard solution for Heavy metals test? what is the purpose of this?