From Scientific Discovery to Clinical Trial: Overcoming the Regulatory Hurdles — A Guide for Academic Researchers
Vaccines have a distinguished history originating from the demonstration by Jenner in 1796 that cowpox could protect against the development of smallpox. Historically, the objective of vaccination was to provide effective immunity to the target disease, and with the introduction earlier this century of widespread immunisation for diseases such as diphtheria, tetanus, polio, smallpox and pertussis, the occurrence of these diseases has been significantly reduced if not eliminated. However, the acceptance of immunisation programs in the community could have been jeopardised by the rare events which occurred as a result of poor vaccine manufacture.
KeywordsGood Laboratory Practice Therapeutic Good Administration Regulatory Hurdle Master Cell Bank Somatic Cell Therapy
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