Pharma Specialists

IID

Regulatory Justification for Exceeding IID Limit of Excipients

1. Risk-Based Scientific Justification A solid scientific ration…

June 10, 2025

IID

Concept of Maximum Daily Intake (MDI) in the Context of the Inactive Ingredient Database

Scenario Imagine you are a pharmaceutical company developing a n…

November 04, 2023

IID

How to calculate Maximum Daily Intake of Excipients using IIG Database of FDA?

IIG (Inactive Ingredient Guide Database) algorithm retrieves the…

June 29, 2022

FDA

FDA Inactive Ingredient Database

According to 21 CFR 210.3(b)(8), an inactive ingredient is any c…

December 09, 2021