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Safety Evaluation of Biotechnology Products
Drug Safety, 1990Preclinical safety studies with biotechnology products are not only performed for regulatory purposes, but should first and foremost provide information about the potential toxic effects in patients. The initial toxicological experience, using standard testing procedures developed for drugs of small molecular weight, often gave disappointing results ...
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Field evaluation of vaccine safety
Vaccine, 2004Surveillance of adverse events in the field represents an essential part of vaccination strategies. Safety studies conducted before vaccine licensure have often not enough power to detect rare or long-term adverse events. Furthermore, adverse events may be caused by incorrect procedures of storage or administration.
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Using human genetics to improve safety assessment of therapeutics
Nature Reviews Drug Discovery, 2022Keren J Carss +2 more
exaly
2010
To an even greater extent than is the case with pharmaceuticals, the regulatory nonclinical safety assessment requirement (called, for devices, biocompatability evaluation) has become globally harmonized. The primary guidance for the USA, EU, and Japan and associated countries have formally become the ISO 10993 standards, with each having reference ...
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To an even greater extent than is the case with pharmaceuticals, the regulatory nonclinical safety assessment requirement (called, for devices, biocompatability evaluation) has become globally harmonized. The primary guidance for the USA, EU, and Japan and associated countries have formally become the ISO 10993 standards, with each having reference ...
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SAFETY EVALUATION OF ETHAMBUTOL
Annals of the New York Academy of Sciences, 1966H F, Diermeier, J A, Kaiser, N, Yuda
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An overview of real‐world data sources for oncology and considerations for research
Ca-A Cancer Journal for Clinicians, 2022Lynne Penberthy +2 more
exaly