Guidance for industry : submission of summary bioequivalence data for ANDAs.

Bibliographic Details
Corporate Author: Center for Drug Evaluation and Research (U.S.)
Format: Government Document eBook
Language:English
Published: Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009]
Subjects:
Online Access:https://purl.fdlp.gov/GPO/LPS112216

MARC

Tag First Indicator Second Indicator Subfields
LEADER 00000cam a2200000 a 4500
001 in00002492463
005 20211202191532.0
006 m d f
007 cr bn|||||||||
008 090505s2009 mdu s f000 0 eng c
035 |a (OCoLC)ocn320234159 
040 |a GPO  |c GPO  |d GPO  |d MvI  |d UtOrBLW 
042 |a pcc 
043 |a n-us--- 
049 |a WWW 
074 |a 0499-T (online) 
086 0 |a HE 20.4702:B 52/DRAFT 
245 0 0 |a Guidance for industry :  |b submission of summary bioequivalence data for ANDAs. 
246 3 0 |a Submission of summary bioequivalence data for ANDAs 
264 1 |a Silver Spring, MD :  |b U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,  |c [2009] 
300 |a i, 9 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 from the CDER web site. Address as of 5/5/09: http://www.fda.gov/cder/guidance/8363dft.pdf ; current access available via PURL. 
500 |a Title from title screen (viewed on May 5, 2009). 
500 |a "Draft guidance." 
500 |a "April 2009." 
500 |a Electronic resource. 
650 0 |a Drugs  |z United States  |x Therapeutic equivalency. 
650 0 |a Drugs  |x Certification  |z United States. 
710 2 |a Center for Drug Evaluation and Research (U.S.) 
856 4 0 |u https://purl.fdlp.gov/GPO/LPS112216  |t 0 
999 |a MARS 
999 f f |s b785d3df-e9af-36ac-899d-73d0c41298ce  |i 0ee9a658-086c-333a-a1f2-768b1e539886  |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:B 52/DRAFT  |h Superintendent of Documents classification 
998 f f |a HE 20.4702:B 52/DRAFT  |t 0  |l Available Online