How to find the maximum daily dose (MDD) to calculate the limit of gentoxic impurity? 

 

来源：http://pharmaregulatory.blog.hexun.com/

There are two choices:

1.      From EMA webite:

I think it's easy for us to obtain the generic name of the API, then check its brand name by wilki.

After obtained its brand name, then check the European Public Assessment Report (EPAR) of this API, for details, please refer to:

On the EMA office website, in the search box, put following information into the filed: EPAR and brand name of the API, ag “ivec EPAR”. Then download the English version, easy done!

2.      FDA website:

a.         home pageà click drug then to Drugs@FDA

b.        then put API name in  "Enter at least three characters" field

c.         then click the dosage brand name

Sometimes, you can’t find relevant content, and then you must try to find other way.