vol1 - Page 155
Page 155
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The Study set forth two objectives:
(I) provide the drug (marijuana/THC) on a
compassionate basis to seriously ill persons not responding to
conventional treatments and
(2) mfacilitate clinical trials of Cannabis and its
derivatives N in some patients pursuant to the federal !ND
procedtlres. 2_/
Xn order _to accomplish these two potentially
conflicting objectivese the Panel planned a large collaborative
Phase IIi trial. _ As noted by the Panei_ 2_// a large=
population Phase Ill study means basic toxicology and
pharmacology tests_ Phase I animal testing and Phase II
evaluation of the drug within normal and small population patient
267/ I d. The Panel indicated the meaning of a Phase IIi
program as follows:
Among the safeguards for developing an
investigational new drug is a step-wise
testing process: the drug is tested in
animals before humans, in normal volunteers
before patients_ and in small _roups of
people before large groups. Preclinical
refers to non-human experiments_ e.g.
toxicity and pharmacology experiments in
animals. _e i is conducted in small
numbers of normal human volunteers to
determine dosage levels and o_ler pharma-
cologic parameters° _ clinical trials
typically involve small numbers of patients
and comparisons to other treatment° £hase
/J_ is to confirm effectiveness and to assess
adverse effects in a large and diverse
patient population. P/I_____ is used to
...... describe post_marketing reporting on drug
safety and effectiveness. _.
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