000 01357nam a22002897i 4500
005 20250923101909.0
008 250702s2015 ii a|||fr|||| 00| 0 eng d
020 _a9788123928814
040 _aEG-GaU‬‬
_cEG-GaU‬‬
_dEG-GaU‬‬
_erda
082 0 4 _223
_a635.1
_bS.G.D
100 1 _aSingh, Gajendra,
_eauthor.
_963211
245 1 0 _aDrug Regulatory Affairs /
_cGajendra Singh, Gaurav Agarwal & Vipul Gupta.
250 _a1st ed.
264 1 _aNew Delhi :
_bCBS Publishers & distributors Pvt Ltd,
_c2015
300 _a192 pages :
_billustrations ;
_c23 cm
336 _2rdacontent
_atext
_btxt
337 _2rdamedia
_aunmediated
_bn
338 _2rdacarrier
_avolume
_bnc
520 _aA practical guide detailing regulatory requirements governing drug development, approval, manufacturing, and monitoring. Covers regulatory bodies' roles, clinical trial regulations, pharmacovigilance, GMP standards, and global guidelines—ideal for students and professionals in pharmaceutical regulatory affairs.
650 0 _aDrug approval
_vRegulatory aspects.
_960054
650 0 _aPharmaceutical regulation.
_960055
650 0 _aClinical trials$xLegislation & jurisprudence.
_960056
700 1 _aAgarwal, Gaurav,
_eauthor.
_960053
700 1 _aGupta, Vipul
_eauthor.
_960057
942 _2ddc
_cBK
999 _c10906
_d10906