Attachment III - Page 
BUREAU OF DRUGS 
GUIDE 
BD 4831.1 
ATTACHMENT A 
observer bias, and how significance will be assessed ). Precautions 
to be taken include ( " ) and (are/are not) adequate. 
(The second protocol ) 
2. General Information 
a. Name of drug 
(1) Generic; 
(2) Proposed trade name; 
(3) Chemical (structure optional); 
b. Pharmacologic Category; 
c. Proposed indication (s ) ; 
d. Dosage form(s) and route(s) of administration; 
e. Related drugs. 
3. Manufacturing Controls (refer to Chemistry Review). List any 
problems with clinical implications, after conference with reviewing 
chemist. 
4. Pharmacology (refer to Pharmacology Review). A brief summary of the 
following taken from the Pharmacology Review, should be included: 
a. Pharmacodynamics 
(1) Primary pharmacologic classification and mechanism of 
action, if known; 
(2) Other actions; 
(3) Results of human studies, if any. 
b. Pharmacokinetics 
(1) Blood level data in animals and humans; 
(a) Half life, if known (species variations); 
(b) percent absorption by various routes, if known 
(species variations). 
CT NO. 
BD 80-23 (8/14/80) 
PAGfc 
2 
