MARC

LEADER 00000cam a2200000Ia 4500
001 in00002496082
005 20211202191952.0
006 m d f
007 cr an|||||||||
008 090706s2001 mdu s f000 0 eng d
035 |a (OCoLC)ocn422637158 
040 |a GPO  |c GPO  |d MvI  |d UtOrBLW 
049 |a WWW 
074 |a 0499-T (online) 
086 0 |a HE 20.4702:C 73/3 
245 0 0 |a Guidance for industry :  |b M4E, the CTD, efficacy. 
246 3 0 |a M4E, the CTD, efficacy 
264 1 |a Rockville, MD :  |b U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :  |b Center for Biologics Evaluation and Research,  |c [2001] 
300 |a iii, 58 pages :  |b digital, PDF file. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
538 |a Mode of access: Internet at the FDA web site. Address as of 7/6/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129865.pdf ; current access is available via PURL. 
500 |a Title from PDF title page (viewed on July 6, 2009). 
500 |a "ICH". 
500 |a "August 2001". 
500 |a Electronic resource. 
650 0 |a Drug approval  |x Government policy  |z United States. 
650 0 |a Clinical trials  |x Reporting  |z United States. 
650 0 |a Drugs  |x Effectiveness  |z United States. 
710 2 |a Center for Drug Evaluation and Research (U.S.) 
710 2 |a Center for Biologics Evaluation and Research (U.S.) 
711 2 |a International Conference on Harmonisation. 
856 4 0 |u https://purl.fdlp.gov/GPO/LPS114345  |t 0 
999 |a MARS 
999 f f |s e6912d60-2f7c-3b33-80bb-ca2cd72b4eee  |i caf7d3e7-1c4a-389e-ba74-9ecd37c5dcd8  |t 0 
952 f f |a Texas A&M University  |b College Station  |c Electronic Resources  |d Available Online  |t 0  |e HE 20.4702:C 73/3  |h Superintendent of Documents classification 
998 f f |a HE 20.4702:C 73/3  |t 0  |l Available Online