by RJTimko | Jun 6, 2019 | Knowledge Management
Have you ever wondered about the long and arduous journey that a drug goes through before coming to pharmacy stores? Overview The journey begins in a laboratory where researchers, spending hours and hours to understand the processes behind a disease and stumble upon a...
by RJTimko | Jul 19, 2018 | Processing
Formulation and process development can be a complex and a time-consuming effort. It can take months depending on the physical and chemical properties of the active pharmaceutical ingredient and the complexity of the dosage form being developed. To assist companies...
by RJTimko | Jan 11, 2018 | Stability
The blending of different ingredients together in a uniform mixture is one of the most basic of pharmaceutical unit operations, but it can also be one of the most challenging to control. The terms ‘blending’ and ‘mixing’ are often used interchangeably, but...
by RJTimko | Nov 16, 2017 | Stability
Starting Materials are the building blocks by which drug substances are assembled. Starting Materials must consistently meet their specifications. However, Starting Materials do not need to be prepared in compliance with GMPs. There are no absolute requirements for...
by RJTimko | Nov 13, 2017 | Stability
In submitting stability data in a NDA, there is the primary data which are generated on the drug substance and drug product prepared by the proposed commercial synthesis/process and proposed commercial formulation/manufacturing process, respectively. In addition,...
