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024 7 _a10.1007/978-981-99-8034-5
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050 4 _aRS400-431
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_2bicssc
072 7 _aSCI013040
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245 1 0 _aIntroduction to Quality by Design (QbD)
_h[electronic resource] :
_bFrom Theory to Practice /
_cedited by N. K. Jain, Neha Bajwa.
250 _a1st ed. 2024.
264 1 _aSingapore :
_bSpringer Nature Singapore :
_bImprint: Springer,
_c2024.
300 _aXXIV, 493 p. 102 illus., 96 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
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505 0 _aChapter 1. Introduction to Quality by Design -- Chapter 2. Regulatory Aspects of Quality by Design (USFDA, PMDA, ICH, EMEA guidelines) -- Chapter 3. Criteria for selection of Design (PAT, CMA,CPA,CQA,RMEA) -- Chapter 4. Analytical Quality by Design -- Chapter 5. API Quality by Design -- Chapter 6. Quality by Design for formulation development -- Chapter 7. Quality by Design for oral formulations (tablets, spheroids) -- Chapter 8. Quality by Design for topical formulations -- Chapter 9. Quality by Design for parenteral formulations -- Chapter 10. Quality by Design approach for Novel Drug Delivery Systems -- Chapter 11. Quality by Design for herbal products/ formulations -- Chapter 12. Quality by Design in Quality Assurance -- Chapter 13. Quality by Design in pharmaceutical packaging -- Chapter 14. Quality by Design and Clinical Trials -- Chapter 15. Applications of Quality by design -- Chapter 16. Quality by Design and Marketing -- Chapter 17. Conclusions and Future perspective.
520 _aThis book offers a comprehensive exploration of the Quality by Design (QbD) methodology, guiding readers from theory to practical application with accessible examples. It equips readers with both foundational and advanced knowledge, emphasizing the critical parameters necessary for designing pharmaceutical products that meet the highest quality standards. The book goes beyond theory to demonstrate how to effectively implement QbD principles in various aspects of pharmaceutical research and development, including analytical methods, formulation, and packaging processes. Through a step-by-step approach, it prepares researchers in pharmaceutical sciences, as well as professionals in the pharmaceutical and healthcare industries (including suppliers), to successfully integrate QbD into their work.
650 0 _aPharmaceutical chemistry.
_967843
650 0 _aDrug delivery systems.
650 1 4 _aPharmaceutics.
_967846
650 2 4 _aDrug Delivery.
_969429
700 1 _aJain, N. K.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
_974951
700 1 _aBajwa, Neha.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
_974952
710 2 _aSpringerLink (Online service)
773 0 _tSpringer Nature eBook
776 0 8 _iPrinted edition:
_z9789819980338
776 0 8 _iPrinted edition:
_z9789819980352
776 0 8 _iPrinted edition:
_z9789819980369
856 4 0 _uhttps://doi.org/10.1007/978-981-99-8034-5
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