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Clinical trial
Before a new drug candidate can proceed to toxicologic or clinical evaluation, considerable analytical chemical development is required to lay the ground work for quality control and stability studies. Drug standards are established and analytical methods for the bulk drug and for the proposed final product are devised. Tentative chemical, physical, and biological specifications of the candidate drug are established. If a compound has desirable activity in an experimental testing system, and appears to be safe upon toxicologic examination, it becomes a candidate for clinical trial. The first trial of a drug in man is done with great caution and on a very limited basis. This study, called Phase I, is devoted primary to ascertaining the safety in the human. When these limits have been established and are found acceptable, the drug is made available to a large number of practicing specialists for the Phase II study, which is principally concerned with the determination of efficacy in patients. If, after Phase II, the drug still looks promising, it is distributed more widely to selected practicing physicians in the Phase III study. The purpose at this stage is to secure data from large number of patients on efficacy and incidence of side effects.
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