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,
|Is This Answer Correct ?||2 Yes||0 No|
acceptance criteria for ph meter, hplc detector,pump,injector,oven when we calibrate.
IN pH CALIBRATION,CALIBRATION IS DONE FOR pH METER OR ELECTRODE?HOW WILL YOU JUDGE THAT THE METER TO BE CALIBRATED WITH 4,7,9.2 BUFFERS?EXPLAIN TEMPERATURE EFFECTS ON pH.
In HPLC when we use Isocratic method, Gradient method in hplc?
How to calculation of residual solvent methanol (3000 ppm) standard solution, and how many quantity used of test sample
What is the function of end capped column?
What is the difference between HPLC and GC?
why we are taking 85 ml of concentrated HCl to prepare 1N Solution
How to choose the which salt is suitable for mobilephase
How would you decide dissolution medium for NCE compound of class I drug
Why Ethanol is Used for Standardization of GC Head space?
What is the size of capillary tube used for analysing melting point?
why we are using sodium,potassium phosphates for mobile phase preparation?