The European clinical trials directive-a regulatory approach for filing drug substance information.
Lettani
Debbie
D
CMC Sciences and Dossier Management, Johnson & Johnson Pharmaceutical Research and Development, Springhouse, Pennsylvania, USA.
DiFeo
Thomas J
TJ
D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004339:Drug Compounding; D004355:Drug Stability; D015507:Drugs, Investigational; D005062:European Union
D015507:Drugs, Investigational