Number of the records: 1
žiadosť o povolenie klinického skúšania nového lieku
SYS d017387 LBL 00000cx--j22000003--45-- 005 20240119201245.3 100 $a 19920520csloy0103----ba0 152 $b mesh 250 $a žiadosť o povolenie klinického skúšania nového lieku $x EC $x HI $x LJ $x MT $x OG $x SN $8 slo 300 1-
$a 93 $8 eng 300 1-
$a Drugs, Investigational (1990-1992) $8 eng 330 1-
$a An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the "New Medicines in Development" Series produced by the Pharmaceutical Manufacturers Association and published irregularly.) $8 eng 450 $a povoľovanie klinického skúšania nového lieku $5 e $8 slo 550 $3 sllk_un_auth*d015507 $Y Drugs, Investigational $5 B $a lieky skúšané 686 $a E05.290.250.400 686 $a E05.337.300.400 750 $a Investigational New Drug Application $8 eng 801 -0
$a US $b DNLM $c 19920520 801 -2
$a SK $b BA006 $c 20061127 820 $a U.S. or foreign, but if U.S., new drug "must be submitted to the FDA" before study in humans $8 eng 980 $x M
Number of the records: 1