Počet záznamov: 1
žiadosť o povolenie klinického skúšania nového lieku
SYS d017387 LBL 00000cz--a2200000o--4500 005 20250606212854.4 008 920520|||anznnbabn-----------|-a|a------ 040 $b slo $a DNLM $d BA006 065 $a E05.290.250.400 065 $a E05.337.300.400 066 $a 01 $c 03 150 $a žiadosť o povolenie klinického skúšania nového lieku $x EC $x HI $x LJ $x MT $x OG $2 slo 450 $w v $a povoľovanie klinického skúšania nového lieku $2 slo 550 $7 sllk_us_auth*d015507 $Y Drugs, Investigational $w b $a lieky skúšané 665 $a 93 $2 eng 665 $a Drugs, Investigational (1990-1992) $2 eng 680 9-
$i 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.) $2 eng 680 $a U.S. or foreign, but if U.S., new drug "must be submitted to the FDA" before study in humans $2 eng 750 -2
$a Investigational New Drug Application $2 eng 980 $x M
Počet záznamov: 1