| 000 | 02278cam a22003614a 4500 | ||
|---|---|---|---|
| 005 | 20150712005536.0 | ||
| 008 | 050110s2005 nyua b 001 0 eng | ||
| 010 | _a2005040476 | ||
| 020 | _a0824754603 | ||
| 040 |
_aDLC _cDLC _dUKM _dC\P _dSDB |
||
| 042 | _apcc | ||
| 050 | 0 | 0 |
_aRS55.2 _b.G455 2005 |
| 060 | _bSG | ||
| 082 | _a615.19 | ||
| 084 |
_a615.19 _bSG |
||
| 100 | 1 | _aShargel ,Leon . | |
| 245 | 1 | 0 |
_aGeneric drug product development _h[[Book] :] _bsolid oral dosage forms / _cLeon Shargel, Isadore Kanfer. |
| 260 |
_aNew York : _bMarcel Dekker, _c2005. |
||
| 300 |
_axi, 381 p. : _bill. ; _c24 cm. |
||
| 440 | 0 |
_aDrugs and the pharmaceutical sciences ; _vv. 143. |
|
| 500 | _aincludes index. | ||
| 504 | _aIncludes bibliographical references and index. | ||
| 505 | 0 | 0 |
_tIntroduction to generic drug product development /. _rLeon Shargel, Izzy Kanfer -- _tActive pharmaceutical ingredients /. _rEdward M. Cohen, Lih-Yang Lin -- _tAnalytical methods development and methods validation for solid oral dosage forms /. _rQuanyin Gao, Robert Vita, Dilip R. Sanvordeker -- _tExperimental formulation development /. _rIzzy Kanfer, Peter Persicaner, Roderick B. Walker -- _tScale-up, process validation, and technology transfer /. _rSalah C. Ahmed, Venkatesh Naini, Dilip Wadgaonkar -- _tDrug stability /. _rPranab K. Bhattacharyya -- _tQuality control and quality assurance /. _rLoren Gelber, Joan Janulis -- _tDrug product performance, in vitro /. _rPradeep M. Sathe ... [et al.] -- _tANDA regulatory approval process /. _rTimothy W. Ames ... [et al.] -- _tBioequivalence and drug product assessment, in vivo /. _rDale P. Conner, Barbara M. Davit -- _tStatistical considerations for establishing bioequivalence /. _rSanford Bolton -- _tScale-up, post-approval changes, and post-marketing surveillance /. _rSadie M. Ciganek ... [et al.] -- _tOutsourcing bioavailability and bioequivalence studies to contract research organizations /. _rPatrick K. Noonan -- _tLegal and legislative hurdles to generic drug development, approval, and marketing /. _rArthur Y. Tsien. |
| 521 | _aAll age. | ||
| 650 | 0 | _aGeneric drugs. | |
| 650 | 0 | _aSolid dosage forms. | |
| 700 | 1 |
_aShargel, Leon, _d1941- |
|
| 700 | 1 | _aKanfer, Isadore. | |
| 001 | 0000024783 | ||
| 003 | 0000 | ||
| 942 | _cBK | ||
| 942 | _cBK | ||
| 999 |
_c55295 _d55295 |
||