Attachment III - Page 5 
BUREAU OF DRUGS 
GUIDE 
BD 4831.1 
ATTACHMENT 
A 
(2) Procedure 
(a) Specific formulation(s) and lot numbers' used in study 
(including the control drug); 
(b) Type of experimental controls (placebo, active drug, 
historical), study design (cross-over, randomization), 
and measures to eliminate bias (single-blind, 
double-blind) comment on appropri ateness and adequacy 
of these procedures; 
(c) 
Dosage schedule, duration of use, and 
administration for study drug (and placebo, 
also describe dosage schedule and route for 
drugs that are administered as part of the 
Describe special diets to be used. Comment. 
route of 
if any); 
any other 
protocol . 
(d) 
If a copy has been submitted by the sponsor, 
informed consent appear adequate? 
does the 
(3) 
Safety considerations - Observations prior to, during, and 
after study. 
(a) 
Clinical studies, i.e., history and 
examinations; 
physical 
(b) 
Laboratory studies 
, 
i routine; 
ii special studies performed because of 
of the drug, the patient population 
results of animal studies, etc.; 
the nature 
involved. 
(c) 
i 
Indications for removing a patient from study (e.g., 
worsening of symptoms, adverse reactions). 
(4) 
Efficacy considerations 
(a) 
Clinical and laboratory measurements 
characterize efficacy or comparability; 
used to 
(b) 
What degree of difference will be (or was) 
significant? 
defined as 
f 
(c) 
Are the proposed endpoints appropriate? 
f «T 
CTN °' BD 80- 
23 (8/14/80) 
KA “ 5 | 
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J 
