| 000 | 02316 a2200337 4500 | ||
|---|---|---|---|
| 001 | 1032920602 | ||
| 005 | 20250328151424.0 | ||
| 008 | 250324042024xx 36 eng | ||
| 020 |
_a9781032920603 _qBC |
||
| 037 |
_bTaylor & Francis _cGBP 44.99 _fBB |
||
| 040 | _a01 | ||
| 041 | _aeng | ||
| 072 | 7 |
_aPS _2thema |
|
| 072 | 7 |
_aTDCW _2thema |
|
| 072 | 7 |
_aTBC _2thema |
|
| 072 | 7 |
_aKND _2thema |
|
| 072 | 7 |
_aPS _2bic |
|
| 072 | 7 |
_aTDCW _2bic |
|
| 072 | 7 |
_aTBC _2bic |
|
| 072 | 7 |
_aKNDP _2bic |
|
| 072 | 7 |
_aMED000000 _2bisac |
|
| 072 | 7 |
_aMED071000 _2bisac |
|
| 072 | 7 |
_a615.19 _2bisac |
|
| 100 | 1 | _aLeon Shargel | |
| 245 | 1 | 0 |
_aGeneric Drug Product Development _bSolid Oral Dosage Forms, Second Edition |
| 250 | _a2 | ||
| 260 |
_bCRC Press _c20241014 |
||
| 300 | _a398 p | ||
| 520 | _bIn this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development. | ||
| 700 | 1 |
_aIsadore Kanfer _4B01 |
|
| 999 |
_c8367 _d8367 |
||