Abstract
Projects that require analytical support can evolve from a number of different situations, for example new molecular entities from drug discovery; process changes; packaging changes; site changes; line extensions; and inlicensed projects and compounds. Laboratory automation has been shown to provide a viable and practical solution to assisting in analytical development. However, it is not always the most logical answer. A truly flexible and responsive analytical unit will make a decision on a case-by-case basis, when faced with a new project, whether it is best to: automate some or all aspects/testing involved; contract out to a reputable and approved contract research organization (CRO); hire temporary help; use available in-house resources; use a combination of the options shown above (for example to evaluate the complexity of the new project versus what the in-house resources are currently working on). The paper discusses the advantages and disadvantages of the various options with respect to providing analytical support and suggests optionsfor the most effective use of resources. The role of automation as one of the important tools in the arsenal of these options is highlighted.
Highlights
Line extensions; and inlicensed projects and compounds
A truly flexible and responsive analytical unit will make a decision on a case-by-case basis, when faced with a new project, whether it is best to: automate some or all aspects/testing involved; contract out to a reputable and approved contract research organization (CRO); hire temporary help; use available in-house resources; use a combination of the options shown above
If the drug is not excessively toxic or is not being used for such indications as cancer and AIDS, the study is done with healthy volunteers
Summary
Most are familiar with the general concept of drug discovery and development and it is not the focus of this particular paper to discuss the various stages of the development process in detail. In general, the life cycle of a drug product follows the stages below: Pre-Phase 0 or ’Phase 00’ This is not a stage of development but rather, the final stage in the discovery process. Even while the Phase III trials are continuing, the preparation for the filing of the new drug application (NDA) is already underway. In the months both before and after approval of the NDA, dosage form life cycle planning will take place, additional Phase IIIB and Phase IV clinical studies will begin, and technical commitments made to the regulatory authorities both during review of the application and site inspection will be dealt with. While some of the work may be classified as routine, for example, stability samples for the registration of alternate package configurations or new formulations, there may be considerable amounts of method development, validation, troubleshooting, preparation and/or review of regulatory documentation, and formulation and process support
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