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By: Tom Branna
January 4, 2018
This column is about patience. We live in an environment and practice a lifestyle that neither appreciates nor fosters patience. We try to adhere to timetables, meet deadlines, work on a schedule. Failing to meet a deadline is equated with failure. But patience must be respected. Some processes cannot be accelerated. Being patient does not mean being passive or lazy. It means being attentive, observant, focused, calm, trustworthy and flexible. A clinical study, if conducted with care and for statistical significance, can encounter a substantial investment and often is what consumers ultimately desire. Therefore, it is critical that aspects related to its potential validity are fulfilled prior to planning and conducting it. Sometimes, due to project timeline commitments, manufacturers seek options to accelerate formulation development. Such practice should not compromise stability of the active compounds or the formulation. Cosmetic products are developed with the intention to maintain at least a two-year shelf life. If the formulation tested in a clinical study is a few days or weeks old and the active compound will degrade over time, the results acquired in the study may not be valid for a product that is purchased after two years of being in a warehouse or on a store shelf. Therefore, it is imperative that stability of both the active and the base formulation are ensured. The term “stability” is used as a comprehensive description of the ability of a product to resist changes in composition and consistency and remain fit and acceptable for use over time. Such changes can adversely affect the performance of the product in providing its intended benefit or efficacy and its aesthetic properties. A degraded active can create the following issues:
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