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010   $a981-19-9002-6
024 7 $a10.1007/978-981-19-9002-1
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035   $a(CKB)26154960300041
035   $a(DE-He213)978-981-19-9002-1
035   $a(PPN)268210071
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100   $a20230214d2023      u|         0
101 0 $aeng
135   $aurcnu||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 10$aPharmaceutical Calibration, Validation and Qualification: A Comprehensive Approach /$fby Shiv Shankar Shukla, Ravindra Kumar Pandey, Beena Gidwani, Gunjan Kalyani
205   $a1st ed. 2023.
210  1$aSingapore :$cSpringer Nature Singapore :$cImprint: Springer,$d2023.
215   $a1 online resource (216 pages)
311 08$aPrint version: Shukla, Shiv Shankar Pharmaceutical Calibration, Validation and Qualification: a Comprehensive Approach Singapore : Springer,c2023 9789811990014 
320   $aIncludes bibliographical references.
327   $aChapter 1. Introduction to Calibration -- Chapter 2. Errors and Uncertainties in Calibrations -- Chapter 3. Calibration Methods and Procedures -- Chapter 4. Calibration Software Support -- Chapter 5. Objectives of Qualification -- Chapter 6. Approach to the Qualification process -- Chapter 7. Objectives, Methods and Roles of Verification -- Chapter 8. Improvement in Software Quality -- Chapter 9. General Principles of Validation -- Chapter 10. Process Validation and its Types -- Chapter 11. Pharmaceutical Equipment Validation -- Chapter 12. Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Nutraceuticals -- Chapter 13. Validation of Pharmaceutical Dosages Form ? Validation of Tablets, Capsules, Liquids and Semisolids -- Chapter 14. Approach for Herbal Standardization -- Chapter 15. Regulatory requirements for herbal medicines in India -- Chapter 16. Expert Opinion on the Basis of the Content.
330   $aThis up-to-date and unique monograph covers the different aspects of pharmaceutical validation, calibration, qualification and documentation. It discusses the various methods and processes under all these heads. It includes eight major sections and exhaustively covers each topic.The book includes interesting and timely topics like the ?Validation of herbals? considering the increasing reliance on herbal medicines. It includes a section of validation of dosage forms, which is an essential topic for any pharmaceutical scientist. The chapters provide lucid illustrations, figures, flowcharts and other diagrams to facilitate understanding. A final section on 'expert opinion' provides a rundown about the global scenario to the readers. The book serves as a complete reference material for students, researchers and industry experts in the field of pharmaceutical sciences, medicinal chemistry and pharmacology.
606   $aPharmacy
606   $aPharmacology
606   $aMedical sciences
606   $aDrug development
606   $aPharmaceutical chemistry
606   $aToxicology
606   $aPharmacovigilance
606   $aPharmacy
606   $aPharmacology
606   $aPreclinical Research
606   $aPharmaceutics
606   $aToxicology
606   $aDrug Safety and Pharmacovigilance
615  0$aPharmacy.
615  0$aPharmacology.
615  0$aMedical sciences.
615  0$aDrug development.
615  0$aPharmaceutical chemistry.
615  0$aToxicology.
615  0$aPharmacovigilance.
615 14$aPharmacy.
615 24$aPharmacology.
615 24$aPreclinical Research.
615 24$aPharmaceutics.
615 24$aToxicology.
615 24$aDrug Safety and Pharmacovigilance.
676   $aQC100
700   $aShukla$b Shiv Shankar$01334123
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910672441503321
996   $aPharmaceutical Calibration, Validation and Qualification$93374075
997   $aUNINA