منابع مشابه
DRUG DEVELOPMENT Immunogenicity: anticipating and avoiding issues for biopharmaceutical development
an immune response in the recipient: this may be the intended effect, as in the case of vaccines, or unintended. Depending on the nature and magnitude of the response, unintended immunogenicity can impact negatively on overall clinical benefit and risk. All biopharmaceutical products have an intrinsic immunogenic potential by virtue of molecular features that can stimulate cells of the adaptive...
متن کاملImplications of Immunogenicity in Drug Development
Introduction Biotherapeutics emerged in the 1970s as viable alternatives to small molecule drugs when the advent of recombinant DNA technology allowed for cost-efficient, large-scale manufacture of proteins in cultured cells under controlled conditions. In 1982, recombinant human insulin, developed by Genentech and Eli Lilly, was the first biotechnology therapy to be approved by the FDA. Since ...
متن کاملAllometric issues in drug development.
The concept of correlating pharmacokinetic parameters with body weight from different animal species has become a useful tool in drug development. The allometric approach is based on the power function, where the body weight of the species is plotted against the pharmacokinetic parameter(s) of interest. Clearance, volume of distribution, and elimination half-life are the three most frequently e...
متن کاملScientific Issues in Botanical Drug Product Development
In recent years, as more and more innovative drug products are going off patents, the search for new medicines such as botanical drug products that can treat critical and/or life-threatening diseases has become the center of attention of many pharmaceutical companies and research organizations such as the United States National Institutes of Health (NIH). A botanical drug product is often recog...
متن کاملPractical Issues in Planning Cross-over Trials in Drug Development
Some practical issues in planning cross-over trials will be considered. A general approach to sample size determination for any arbitrary cross-over will be described. This also permits sample size determination when it is intended to recover inter-block information for incomplete block cross-overs. Consideration will also be given to planning to mimimize the effect of carry-over. Some aspects ...
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ژورنال
عنوان ژورنال: Journal of Immunotoxicology
سال: 2006
ISSN: 1547-691X,1547-6901
DOI: 10.1080/15476910600908852