Any new medical discovery—particularly one that has promise of merit as a therapeutic agent—arouses general interest. An investigator who is commercially disinterested is promptly embarrassed by promotional schemes to capitalize his discovery. How, he inquires, may the remedy be introduced in a manner that will inspire confidence in the therapeutic agent, protect the scientific interests of the research worker, and possibly repay in some part the expenses of the investigation, or aid future research in the institution in which the discovery was made? For many years the Council on Pharmacy and Chemistry has fostered certain broad principles governing the introduction of drugs. The fundamental considerations were summarized in a paper1 read at the annual session of the Association in Portland in 1929:
The composition must be known, including adequate evidence of constitution and molecular structure, together with methods of assay.
The action of the drug on experimental animals should
THEELIN—AND THE TECHNIC OF INTRODUCTION OF NEW DRUGS. JAMA. 1931;97(21):1541-1542. doi:10.1001/jama.1931.02730210039014