Establishing a phase I unit: organisation.
The organisation of a phase I unit must take into account the safety, quality and scientific requirements of such studies. The clinical pharmacology unit demands a highly qualified staff, as well as intensive care equipment. The investigator, generally a clinical pharmacologist who coordinates the different tasks as a project leader, has often to initiate a fruitful collaboration with a specialised consultant staff in order to implement the studies.
de Lauture
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D
Institut de Recherche Thérapeutique, Hôpital Cochin, Paris, France.
Kahan
A
A
Pinquier
J L
JL
D004341:Drug Evaluation / Q000379:methods*; D005602:France; D006801:Humans; D010601:Pharmacology, Clinical; D011786:Quality Control; D012107:Research Design