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International Clinical Trials

Critical Paths: The Stability Game

Forming a vital part of the documentation for any drug submission, Mark Hammond and Carol Barbour of Melbourn Scientific explain how to maximise stability studies during product development

Stability studies are performed at various stages in the development of a pharmaceutical product – from development through to manufacture – to ensure that the dosage form has a consistent potency and has not acquired any undesirable changes in performance or appearance during storage. The testing is designed to provide evidence on how the quality of the drug product will vary when it is exposed to a variety of environmental factors such as temperature, humidity and light. Data generated from the studies helps to establish either a re-test period for a drug substance or a shelf-life and recommended storage conditions for a manufactured product.

DEVELOPMENT STAGES

Informal stability studies are performed at early stage development to assess different formulations before selecting the final candidates to undergo formal testing. Studies undertaken during the development phase will include testing the stability of the drug substance alone and with key intermediates, and packaging studies to show that adequate protection from the external environment is provided. Depending on the nature of the final product, there may also be requirements for in-use testing – for instance, to evaluate the effect of air and moisture entrance into multi-dose formulations after opening.

In the past, stability study protocols used to vary according to the development experience of the pharmaceutical company. However, following the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) these studies are becoming more consistent. ICH guidelines have been issued and are regularly updated.


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Mark Hammond is Business Development Director of Melbourn Scientific. Mark has several years experience in the field of analytical chemistry having started his career as an analyst at Melbourn Scientific. After reading for a degree in Chemistry at Anglia Ruskin University (as it is now called) on day release during his time at MSL, Mark spent six years in sales and marketing roles at Shimdzu, Varian and Applied Biosystems. Returning to Melbourn as Business Development Manager in April 2003, Mark was promoted to the Board of Directors in August 2006.

Carol Barbour is Technical Director of Melbourn Scientific Ltd. She graduated from Strathclyde University in 1979 with a BSc in Pharmacy. She then spent a year in a hospital pharmacy prior to her further studies, gaining an MSc and PhD in Pharmaceutical Analysis from Strathclyde University. After completion of her university work, Carol gained industrial experience and membership of both the Royal Society of Chemistry and the Royal Pharmaceutical Society. During her career, she acquired extensive experience at Ethical Pharmaceuticals and Glaxo Group Research (now GSK), before joining Melbourn Scientific. Carol has particular responsibility for the maintenance and implementation of the Melbourn Scientific Data Review strategies and systems.

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Mark Hammond
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Carol Barbour
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