Aryendu Kumar

4 Questions 3 Answers 0 Followers

Questions related from Aryendu Kumar

Why type F reactions are considered adverse when infact they are only due to failure of the therapy ?

Type F ADR are due to failure of therapy like lack of efficacy of lithium, then, why there are called adverse when in reality there is no adversity related to it ?

04 September 2022 9,872 4 View

Which team is necessary to check initially if a new drug application is filed to FDA ?

I have read that when a new drug application is filed to FDA, then, it is initially checked for its filability, so, who checks if it is fillable or not ? Is it CDER or reviewer team ? Are...

14 August 2022 8,575 0 View

How to assess the severity of adverse drug reaction on the premise of Hartwig and Siegel scale?

I have a question related to severity assessment of ADR and that is if a patient is hospitalized due to some ADR caused by drug and has reported 6 adverse drug reactions for example, neutropenia,...

05 January 2020 6,422 3 View

Can a literature based monitoring of ADR be considered as a research project ?

Can case processing (triage, causality, etc.) of published case reports on a particular drug be considered as research project?

03 November 2018 1,948 6 View