Stability testing of biological drugs should be more comprehensive than that of small molecule compounds. It should cover many more aspects of drug development & manufacturing, including holding time, shipping, freeze/thaw cycles, temperature, exposure to oxygen & light, physical stress, and excipient & container compatibility. Some characterization work should be done early in the development of a drug to identify the degradation pathways so that potential problems associated with stability, storage conditions and formulation design can be avoided during clinical trials. Forced degradation studies exposes a drug substance to harsher conditions than the product would be expected to experience and determining at what point & how it degrades. Some characterization work should be done early in the development of a drug to identify the degradation pathways so that potential problems associated with stability, storage conditions and formulation design can be avoided during clinical trials. A good understanding of product stability early on can help companies make assessments and comparisons on product comparability following manufacturing changes.
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Address: 9885 Mesa Rim Road, Suite 101, San Diego, California 92121, USA
https://moleculardepot.com |
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Phone: +1-(858)-900-3210
Molecular Depot LLC specialize in the development of research tools and biochemicals. Our products include specialty bacterial culture media, antibodies & antigens, enzymes & proteins, chemical compou
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Address: 105 A Regency Blvd, Greenville, North Carolina 27834, USA
www.hascientific.com |
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Phone: +001-(252)-752-4315
H&A Scientific, Inc. develops & delivers software and hardware products based primarily on the needs of pharmaceutical & medical device companies. We offer complete stability database management syste
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Address: 19601 Clark Graham, Baie D Urfe, Montreal, Quebec H9X 3T1, Canada
www.itrlab.com |
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Phone: +1-(514)-457 7400, 457-8264
ITR Canada is an international contract research organization that provides non-clinical toxicology services for the biotechnology and pharmaceutical industries. We offer services in the areas of mamm
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