000			01700nam a2200181Ia 4500
008			140223b2004 xxu||||| |||| 00| 0 eng d
020			_a9780849317460 _c0.00
082			_a615.14 _bNIA
100			_aNiazi, Sarfaraz K.
245			_aHandbook of Pharmaceutical Manufacturing Formulations: Sterile Products Vol.VI
260			_aBoca Raton _bCRC Press _c2004
300			_a354p
500			_aThe sixth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers the sterile products, which include formulations of injections, ophthalmic products and other products labeled as sterile, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing sterile products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics inspection of sterile products manufacturing facilities, new drug application for sterilized products, in addition to providing quick tips on resolving the common problems in formulating sterile products as well as the scope of details included in the series for all dosage forms.
600			_aDosage
600			_aPharmaceutical Formulations
890			_aUSA
995			_ANIA _B004425 _CPHA-NIP _D13295.24 _E0 _F049 _G90195 _H0 _I0.00 _L20060228 _M6 _UC _W20060310 _XHimanshu Book Co.P _ZReference
999			_c15616 _d15616