Analytical development definition
Analytical development. As a first step, method comparability between TG1, VG1 and FG1 will be established in accordance with the “Analytical Development Proposal for BA058, API Project (Lonza RDS-001)” attached here as Exhibit B). If needed, additional method development may be performed to identify the method of choice. Once identified, the methods of choice (probably two) that are suitable for quantification of process impurities and supportive of ICH-stability studies will identified and agreed by the parties. Resulting product will be greater than 97% pure as measured by the Manufacturer’s method FG1. Release will be performed using the TG1 method, originally developed by Ipsen, unless otherwise agreed upon in advance based upon the outcome of the analytical method qualification.
Examples of Analytical development in a sentence
Definition of the protocols for Analytical development, Pharmaceutical development and Stability Test.
Analytical development will be managed through an agile development cycle.