000			02705nam a2200385 i 4500
005			20250919132117.0
008			190523s2018 xxka g b 001 0 eng
020			_a9780128027868 _qhardback _cRM625.50
035			_a20505383
039		9	_a201909231238 _bjamain _c201909201229 _djamain _c201909041613 _dros _y05-23-2019 _zbinar
040			_aUk _beng _cUk UKM _erda
090			_aRS192.A263
090			_aRS192 _b.A263
245	0	0	_aAccelerated Predictive Stability (APS) : _bfundamentals and pharmaceutical industry practices / _cFenghe Qiu, Garry Scrivens.
264		1	_aLondon : _bAcademic Press, _c2018.
264		4	_c©2018.
300			_axxix, 481 pages : _billustrations ; _c24 cm.
336			_atext _btxt _2rdacontent
337			_aunmediated _bn _2rdamedia
338			_avolume _bnc _2rdacarrier
504			_aIncludes bibliographical references and index.
505	0		_aPart I: General Chapters 1. Introduction 2. Regulatory Expectations and Industry Practice on Stability Testing 3. ASAP Theory and Fundamentals 4. Practical Considerations 5. Packaged Products 6. Data Evaluation and Statistical Methods 7. Assessing the Suitability of ASAP for the Sample 8. Application of ASAP in the Pharmaceutical Industry 9. The Value of ASAP in Early Clinical Drug Product Development 10. Embedding ASAP within Business 11. ASAP Regulatory Strategy and Acceptance and Feedback Part II: Industry Practices 12. ASAP Application in Product Development 13. Methods for the Analysis of Data from Accelerated Stability Studies 14. ASAP Application in Packaging Selection 15. ASAP Application in Post-approval Process Development 16. Using ASAP to Predict the Retest Period of an Unusually Unstable Drug Substance and to Select Prototype Formulations 17. Shelf Life Prediction and Packaging Selection of a Humidity-sensitive Product 18. ASAP Application in Suspension and Lyophilized Products 19. ASAP Application in Generic Products 20. Application of ASAP to Nicorette® Lozenges 21. Implementing an Accelerated Stability Assessment Program 22. ASAP: Case Studies from Early and Late Pharmaceutical Development Stages 23. Application of ASAP for Dissolution Predictions.
650		0	_aPharmaceutical technology.
650		0	_aPharmaceutical industry.
700	1		_aQiu, Fenghe, _eeditor.
700	1		_aScrivens, Garry, _eeditor.
907			_a.b16726649 _b2019-11-12 _c2019-11-12
942			_c01 _n0 _kRS192.A263
914			_avtls003648168
990			_aros/jm
991			_aFakulti Sains dan Teknologi
998			_at _b2019-10-05 _cm _da _feng _gxxk _y0 _z.b16726649
999			_c640622 _d640622