In the European Union countries and countries that follow the EU Directives, the equivalent information that is required for a new product application is an effective Investigational Medicinal Product Dossier (IMPD). For those countries, which wish to conduct clinical research in the United States, ...
Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects 2. Pharmacological and toxicological effects... 3 Psilocybin and Psilocin Actions on Neurotransmitter Systems... 3 Overview... G Joop,C Adam - 《...
Forborderlineproducts(i.e.wheretherecouldbeuncertaintywhethertheproductisadeviceor amedicinalproduct),itisofparticularimportancetoincludethescientificrationaleforthe qualificationasdevice,andtoalignwiththeMDCG2022-5guidance13. Further,ifthestudyisastudycombiningdeviceandmedicinalproduct,clearinformationonthe ...
(IB) translations are an essential multilingual communications asset for regulatory compliance. Within the high volumes of documentation sponsors must submit throughout each trial phase, IBs are among the most important functions primarily to assess the benefits and risks of the investigational product (...
Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects A review of the Investigator's Brochure and Clinical Study Reports for 58 non-oncology small molecule and biopharmaceutical drug candidates tested in ...