by Dr. Yashashwini Reddy | Jun 7, 2024
Diluents are used in tablet formulation for several reasons, but one of the main reasons for using tablet formulation is to increase the bulk of the tablets. Some that are used as tablet diluents include starch, sucrose, talc, fructose, mannitol (pearlitol ),...
by Dr. Yashashwini Reddy | Jun 6, 2024
The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform...
by Dr. Yashashwini Reddy | Jun 4, 2024
Drug Master File Submission Process We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short. Procedure for DMF submission Electronic Common Technical Document (eCTD): DMFs...
by Dr. Yashashwini Reddy | Jun 2, 2024
In this article, we are going to see the overview of the Purple Book and its contents, and how it helps healthcare professionals, The FDA Purple Book contains the list of approved biological products, and here we are going to see the details of the Purple book, its...
by Dr. Yashashwini Reddy | May 19, 2024
For tablet coating operation, we use different capacities of pan according to the batch size so how do we select a specific pan capacity for the batch to ensure an efficient coating process, let’s see in detail in this article Tablet coating machines will have...
