00899nam0 22002531i 450 UON0027383620231205103805.98420060224d1964 |0itac50 bagreGR|||| 1||||Anthe apo kepous xenousKoule AlepeAthenaTo Elleniko Biblio1964146 p.24 cm.GRAteneUONL000203889Letteratura greca moderna21ALEPEKouleUONV158730691293To Elleniko BiblioUONV271430650ITSOL20240220RICASIBA - SISTEMA BIBLIOTECARIO DI ATENEOUONSIUON00273836SIBA - SISTEMA BIBLIOTECARIO DI ATENEOSI GRECO A 0642 SI MR 80676 5 0642 Anthe apo kepous xenous1243221UNIOR01371nam0 22003253i 450 VAN0025479820240806101441.777N978354036094020230216d1969 |0itac50 bafreDE|||| |||||Problèmes combinatoires de commutation et réarrangementsP. Cartier, D. FoataBerlinSpringer196988 p.ill.24 cm05-XXCombinatorics [MSC 2020]VANC019812MF05A05Permutations, words, matrices [MSC 2020]VANC023152MFCombinatoricsKW:KBerlinVANL000066CartierPierreVANV024340348843FoataDominique C.VANV20776225378Springer <editore>VANV108073650ITSOL20250221RICAhttps://doi.org/10.1007/BFb0079468E-book – Accesso al full-text attraverso riconoscimento IP di Ateneo, proxy e/o ShibbolethBIBLIOTECA DEL DIPARTIMENTO DI MATEMATICA E FISICAIT-CE0120VAN08NVAN00254798BIBLIOTECA DEL DIPARTIMENTO DI MATEMATICA E FISICA08DLOAD e-book 5432 08eMF5432 20230301 Problèmes combinatoires de commutation et réarrangements3008271UNICAMPANIA03573nam 22005775 450 991098828520332120250320115241.03-031-86504-910.1007/978-3-031-86504-6(CKB)38012104400041(DE-He213)978-3-031-86504-6(MiAaPQ)EBC31973333(Au-PeEL)EBL31973333(EXLCZ)993801210440004120250320d2025 u| 0engur|||||||||||txtrdacontentcrdamediacrrdacarrierPharmaceutical Manufacturing Deviation and Failure Investigations Principles, Practices, and Case Studies /by Ajay Babu Pazhayattil, Sanjay Sharma1st ed. 2025.Cham :Springer Nature Switzerland :Imprint: Springer,2025.1 online resource (XIII, 152 p. 49 illus., 38 illus. in color.) AAPS Introductions in the Pharmaceutical Sciences,2522-8358 ;33-031-86503-0 Chapter 1: Initial Actions and Information Gathering -- Chapter 2: Root Cause Analysis (RCA) Methods -- Chapter 3: Analytical Tools for Investigation and Generation of Supporting Evidence -- Chapter 4: Management of Deviation and Failure Investigation -- Chapter 5: Post-RCA Impact Assessment, CAPA, and Effectiveness Checks -- Chapter 6: Case Study: Dissolution OOT Observed for an Extended-Release Tablet Formulation -- Chapter 7: Case Study: OOS Uniformity of Dosage Units (Stratified Samples) for a Capsule Formulation -- Appendix I: Non-Conformance/Deviation Investigation -- Appendix II: OOS Failure Investigation -- Appendix III: Review of CDMO Investigation Report.This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the indispensable necessity of a robust investigation. The textbook thoroughly explores the standard tools and techniques for conducting scientifically grounded and data-driven investigations. Its overarching objective is to elucidate systematic investigation methodologies that yield effective corrective and preventive actions, ultimately reducing regulatory risks. This book offers a comprehensive overview of standard tools and techniques, focusing on science-based and data-driven approaches. Tailored for professionals in pharmaceutical manufacturing, this book is your go-to resource for mastering investigations in the manufacturing of patient-critical pharmaceutical products.AAPS Introductions in the Pharmaceutical Sciences,2522-8358 ;3PharmacologyPharmacyPharmacovigilancePharmacologyPharmacyDrug Safety and PharmacovigilancePharmacology.Pharmacy.Pharmacovigilance.Pharmacology.Pharmacy.Drug Safety and Pharmacovigilance.615Pazhayattil Ajay Babuauthttp://id.loc.gov/vocabulary/relators/aut1057742Sharma Sanjayauthttp://id.loc.gov/vocabulary/relators/autMiAaPQMiAaPQMiAaPQBOOK9910988285203321Pharmaceutical Manufacturing Deviation and Failure Investigations4348930UNINA