Pharmaceutical analysis during product life cycle

PHARMACEUTICAL ANALYSIS DURING PRODUCT LIFE CYCLE 

FIGURE I Life cycle for new drug development. EIH, entry into humans FDDP, full development decision point. 

Critical activities for each development phase or milestone in a new product s life cycle are summarized below. The key analytical support, activities, and associated documentation are described for each phase. The activities are generally applicable but may vary considerably for a particular program depending on the nature of the new chemical entity and the therapeutic indication. The activities are also applicable to line extension products or generic products but will be abbreviated because of the significant body of data available for the original/innovator product. 

The primary goal during candidate screening is to rank a large number of compounds based on efficacy in animal models, biopharmaceutical properties (such as solubility and permeability in caco-2 cells), preliminary pharmacokinetic profile in animals, and potential for metabolic and toxicity liability. A non-good laboratory practice (GLP) Ames test may be performed to screen for potential mutagenicity. 

Note that analytical activities for protein pharmaceutical products follow similar principles but use methods for in vitro or in vivo (animal model) bioactivity, electrophoretic and chromatographic methods, amino acid analysis, peptide mapping, sequencing, etc., for characterization. 

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III. PHARMACEUTICAL ANALYSIS DURING PRODUCT LIFE CYCLE... 

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