what is dossiar ? How can I submit to the regulatory
department ?
Answer Posted / suvra jyoti dutta
Dossier is a file document submitted for the approval of
drug product.It is submitted in form of CTD to the
regulatory agency. CTD is a harmonized format (template)
for presenting data in the ICH regions.
Is This Answer Correct ? | 4 Yes | 0 No |
Post New Answer View All Answers
why didn't you go back to previous employer after shifting to bangalore?
from hplc chromatogram how can we say that calibration is needed now?
what is the mechanism of action of local anaesthetics?
how to calculate potency of working standard by using mass balence method & this calculated potency is on as basis or on anhydrous/ dried basis
Can any one tell me that which brand hplc column is used for levetiracetam imp- b test.
Do you think it is possible to rehabilitate?
what is the leak test procedure of filled bottles (liquid)
Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
What aspect of your communications skills have you improved the most in and how did you accomplish this improvement?
Tell us about a situation in which you took the extra step for a patient.
How to preform dissolution profiling
What are your intentions towards the uplift of the hospital.
What is difference between Warm and Lukewarm Water as per pharmacopia.
when we connect the capacitor banks in series with the circuit? 2 144 pH is having unit?
Tell us about your oncology experience.