Method transfer goals

This chapter deals with the validation of capillary electrophoresis (CE) methods. It describes the various validation characteristics, namely accuracy, precision, specificity, detection limit, quantitation limit, linearity, and range in accordance with the official guidelines. Practical aspects related to the calculation of these parameters and factors affecting them in CE analysis have also been described. Validation requirements have been described according to the goal of the method. The chapter contains numerous tables and diagrams to illustrate these ideas. It also covers other related aspects such as instrument qualification, revalidation, and method transfer. 

As stated before, expectations and scope of transfer projects should be clearly defined to ensure a clear path toward the end goal, a successful method transfer. This is best... 

Method transfer is the first step toward the end goal, that is, being able to use this method for testing at the appropriate level. However, this step sets the tone for the whole process. It is important to consider the following when initiating method transfer between labs ... 

A lot of effort is invested at the beginning of the project in defining the scope of work and expectations for transfer completion. This is best covered in a document defining the scope and goal of the method transfer, the regulatory standard to be applied (e.g., following GLP or not), experimental outline, acceptance criteria for assay performance, and transfer or development summary or report. It is useful to spend some time on such a protocol to reduce the risk of misunderstanding and to assure that expectations from both sides match. 

As stated earlier, a commercially useful computational method must be fast, accurate, transferable, and interpretable. Logical steps one can take towards this goal are now presented. It is important to point out that under current resources, these four criteria cannot be simultaneously optimized. With current computational capabilities, the most complete theoretical description of protein-ligand interactions (which may involve many-body terms) cannot... 

Improvement of intraparticle mass transfer is the goal of some particle research efforts. One novel approach that has been recently tested is the co-immobilization of algae with bacteria the algae produced oxygen and the bacteria produced the desired product (Chevalier and de la Noue, 1988). Another method used microporous particles entrapped within alginate bead bioparticles to prevent excess biomass growth that could hinder intraparticle mass transfer (Seki et al., 1993). 

The level 3 method is used until synthetic routes and formulations have been finalized and forced degradation and preliminary stability studies have been conducted i.e., until the components that need to be separated in the final DS and in the final DP have been clearly determined. At this juncture, the focus shifts to the development of fast, robust and transferable final methods to be used for primary stability studies and post-approval analyses. Freqnently, separate methods are developed for DS and DP since the goals of each method are different (see Section I). Orthogonal methods continue to be of importance to troubleshoot any questions that may arise during the subsequent life cycle of the drug. 

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