| 000 | 02489cam a22003854a 4500 | ||
|---|---|---|---|
| 999 |
_c12894 _d12894 |
||
| 001 | 13837865 | ||
| 005 | 20210307123809.0 | ||
| 008 | 050110s2005 nyua b 001 0 eng d | ||
| 010 | _a 2005040476 | ||
| 020 | _a0824754603 (hbk. : alk. paper) | ||
| 040 |
_aEG-NcFUE _cEG-NcFUE _dEG-NcFUE _erda |
||
| 042 | _apcc | ||
| 050 | 0 | 0 |
_aRS55.2 _b.G455 2005 |
| 082 | 0 | 0 |
_222 _a615.19 _bG |
| 245 | 0 | 0 |
_aGeneric drug product development : _bsolid oral dosage forms / _c[edited by] Leon Shargel, Isadore Kanfer. |
| 264 | 1 |
_aNew York : _bMarcel Dekker, _c[2005] |
|
| 264 | 4 | _a©2005. | |
| 300 |
_axi, 381 pages : _billustrations ; _c24 cm. |
||
| 336 |
_2rdacontent _atext |
||
| 337 |
_2rdamedia _aunmediated |
||
| 338 |
_2rdacarrier _avolume |
||
| 440 | 0 |
_aDrugs and the pharmaceutical sciences ; _vv. 143 |
|
| 504 | _aIncludes bibliographical references and index. | ||
| 505 | 0 | _aIntroduction to Generic Drug Development Leon Shargel and Izzy Kanfer; Active Pharmaceutical Ingredients Edward Cohen and Lih-Yang Lin; Analytical Methods Development and Validation Nicholas Cappuccino; Experimental Formulation Development Izzy Kanfer, Peter H.R. Persicaner, and Roderick B. Walker; Scale-up, Technology Transfer and Validation Salah U. Ahmed, Venkatesh Naini, and Dilip Wadgaonker; Product Stability Pranab K. Bhattacharyya; Quality Control and Quality Assurance Loren Gelber and Joan Janulis; Drug Product Performance, In Vitro Pradeep Sathe, Larry Ouderkirk, Ajaz Hussain, and Lawrence X.Yu; ANDA Regulatory Approval Process Timothy W. Ames, Karen A. Bernard, Beth Fabian Fritsch, Koung Lee, Aida L. Sanchez, Krista M. Scardina, and Martin Shimer; Bioequivalence and Drug Product. | |
| 520 | _aDescribes the development of solid oral generic drug products from project initiation to market approval - collecting discussions from more than 30 noted specialists on topics such as quality control and quality assurance, experimental formulation, pharmaceutical ingredients, drug delivery, and bioequivalence. | ||
| 650 | 0 | _aGeneric drugs. | |
| 650 | 0 | _aSolid dosage forms. | |
| 700 | 1 |
_aShargel, Leon, _d1941- _eeditor |
|
| 700 | 1 |
_aKanfer, Isadore. _eeditor |
|
| 856 | 4 | 2 |
_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0647/2005040476-d.html |
| 906 |
_a7 _bcbc _corignew _d1 _eocip _f20 _gy-gencatlg |
||
| 942 |
_2ddc _cBK |
||