Clinical trials Good Laboratory Practices

All infants in clinical trials should be characterized with regard to factors which might affect the planned outcomes. Blind randomization with respect to the allocation of test and reference formulas is important, and all studies should comply with Good Clinical and Good Laboratory Practices. 

There are a number of other regulations/directives that you will need to consult, as appropriate. These address topics such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), the conduct of clinical trials, variations to authorised drugs, and the use of genetically modified organisms. A list of the most relevant directives is shown in Table 1.5. 

Regulatory authorities perform the watchdog role to ensure that animal studies comply with Good Laboratory Practice (GLP), clinical trials are... 

All pivotal studies, such as the main teratology study and any range-finding study performed to support the inclusion of women of childbearing potential in clinical trials, must be performed in compliance with Good Laboratory Practice. 

Products used in human clinical trials must, of course, conform to good laboratory, good clinical, and good manufacturing practice requirements. ]... 

In addition, all nonclinical toxicology studies that are intended to support clinical trials or marketing applications must be conducted in compliance with Good Laboratory Practices guidelines... 

These assays, which have been standardized and validated at InterceU AG s Ghni-cal Immunology Laboratory, enable reliable measurements of epitope-specific T cell responses induced by vaccination. All assays were performed in compliance with Good Laboratory Practice (GLP)/Good Clinical Practice (GCP) requirements. Standardization of the blood cell isolation procedure at the different investigational sites led to a high rate of evaluable assays. However, due to the lack of inter-laboratory standardization of T cell assays, comparison of the results of this study with published data from similar trials is difficult. Cryopre-served blood cells were used, which may have resulted in a possible underestimation of T cell responses compared with assays that utilize fresh blood. 

---