05151nam 2200649 a 450 991102024070332120200520144314.0978111849494311184949469781283917537128391753X9781118494936111849493897811184948821118494881(CKB)2670000000308732(EBL)1092861(OCoLC)823726452(SSID)ssj0000784926(PQKBManifestationID)11443020(PQKBTitleCode)TC0000784926(PQKBWorkID)10794631(PQKB)11137193(MiAaPQ)EBC1092861(Perlego)1002855(EXLCZ)99267000000030873220120712d2013 uy 0engur|n|---|||||txtccrA history of a cGMP medical event investigation /Michael A. BrownHoboken, N.J. J. Wiley & Sonsc20131 online resource (251 p.)Description based upon print version of record.9781118396612 1118396618 Includes bibliographical references and index.Title page; Copyright page; Dedication; Contents; Preface; ***; PART ONE: The Event; 1: Francesca; ***; PART TWO: Drug Discovery:Five Years Earlier; 2: Katlin BioScience: Transgenic Mouse Study; 3: Oxy-Fox Inhaler; 3.1 Kinnen Laboratories; 3.2 Kinnen Laboratories: Oxy-Fox Transfer; 3.3 Due-Diligence Team and Katlin Data Acceptance; PART THREE: Kinnen Oxy-Fox Inhaler Market Launch Program; 4: Agency IND and NDA Requirements, Six Sigma Charter, and Device Master Record; 4.1 Launch Team Meeting Number 1; ***; ***; ***; 4.2 Meeting with Medical Affairs: Toxicity Studies5: Meeting Minutes Guidelines5.1 Launch Team Meeting Number 2; ***; 6: Project Timing, Marketing Plan, and Offshore Molding; 6.1 Launch Team Meeting Number 3; 6.2 Project Financial Review; 6.3 Progress Meeting: Who Takes Credit for What?; 6.4 Morning meeting: Just-in-Time Manufacturing; 7: cGMP Process Validation Requirements; 7.1 Launch Team Meeting Number 4; ***; 8: Failure Mode Effects Analysis; 8.1 Launch Team Meeting Number 5; ***; 9: Design for Manufacturability, Design for Six Sigma, Concurrent Design; 9.1 Product Development Meeting Number 1; ***9.2 Update Meeting with Ed Chase and Gordon Taylor10: Design Fishbone Diagram; 10.1 Launch Team Meeting Number 6; 11: Product Specifications; 11.1 Product Development Meeting Number 2; 12: Design Control; 12.1 Design Team Meeting Number 7; 12.2 Product Development Staff Meeting; 12.3 Engineering One-on-One; 12.4 Program Update; 13: Design of Experiments (DOE); 13.1 Molding Team Meeting; 14: Start-Up Issues; 14.1 Oxy-Fox Inhaler Wrap-Up and Equipment Start-Up; ***; 14.2 The Final Management Review; ***; PART FOUR: Present Day: Funeral; 15: Grief; ***; 16: The Autopsy Results; ***17: The Agency***; ***; PART FIVE: Agency Medical Event Letter; 18: Kinnen Notification; 18.1 Another Agency Letter; 18.2 Medical Event Review Meeting; ***; 19: Investigation Team Management; 19.1. Morning Meeting with Gail Strom, Marcia Hines, and Dan Garvey; 20: DMAIC Investigation Process; 21: Internal Quality Review; 21.1 Meeting with Gail Strom and Marcia Hines; 21.2 Executive Management Review; ***; ***; ***; 22: The Agency Audit Letter; ***; 23: Agency Arrival; ***; 24: The Audit24.1 Agency Meeting to Review Qualification Documents and the Quality Acceptance Records of First Lot to Stock***; 24.2 Agency Meeting to Review the Oxy-Fox Inhaler Lot Used in the NDA Clinical Studies; 24.3 Agency Meeting to Review the Design and Program Team Meeting Minutes; ***; 24.4 Agency Meeting to Review the Due-Diligence Report, Katlin Studies, and Oxy-Fox Design History File; ***; 25: End-of-Day Agency Wrap-Up Meeting; ***; 26: Kinnen Management Review; ***; ***; PART SIX: Reckoning; 27: Blame and Responsibility; 27.1 The Investigation Is a Public Record; 27.2 Kinnen Wrap-Up; ***28: Closure Case study details the right way and the wrong way to successfully develop and market a new drug Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization. From initial transgenic mouse studiesDrugsSide effectsReportingUnited StatesDrugsSide effectsReporting615.5/8Brown Michael A.1945-1842382MiAaPQMiAaPQMiAaPQBOOK9911020240703321A history of a cGMP medical event investigation4422456UNINA06418nam 22006855 450 991100255470332120250514130256.03-031-87124-310.1007/978-3-031-87124-5(CKB)38776106500041(DE-He213)978-3-031-87124-5(MiAaPQ)EBC32111093(Au-PeEL)EBL32111093(OCoLC)1524420134(EXLCZ)993877610650004120250514d2025 u| 0engur|||||||||||txtrdacontentcrdamediacrrdacarrierHome Literacy Environment and Literacy Acquisition Evidence from Different Languages and Contexts /edited by George Georgiou, Tomohiro Inoue1st ed. 2025.Cham :Springer Nature Switzerland :Imprint: Springer,2025.1 online resource (XXI, 374 p. 12 illus., 9 illus. in color.) Literacy Studies, Perspectives from Cognitive Neurosciences, Linguistics, Psychology and Education,2214-0018 ;263-031-87123-5 Part1 Theories and measurement -- 1.Home Literacy Environment: Challenges in Measurement and Structural Implications -- 2.Reconciling two conceptualizations of what matters in home literacy environment -- 3.Home Supports for Learning and Home-School Connections: A Descriptive and Comparative Review of Evidence from Low- and Middle-Income Countries -- 4.The Intersections of Home Literacy and Home Numeracy Environment in Different Countries and Contexts -- 5.genetic and environmental etiology of literacy acquisition. -- part2. HLE and literacy across languages and contexts -- 6.The home literacy environment in families with a history of reading difficulties -- 7.Home literacy environment: The link between parents' education, parents' expectations and children's literacy skills in Greek -- 8.Home literacy Environment and literacy acquisition in Finnish: The moderating role of familial risk of dyslexia -- 9.The role of the Home Literacy Environment in the early reading and writing development ofChinese children -- 10.Relationship between home literacy environment and early biscriptal literacy: Evidence from Japanese -- 11.Home literacy as a learning ecosystem: Insights from the Philippines -- 12.Home Literacy and Emergent Literacy Skills in low-SES families in Latin America -- 13.Home literacy activities: Accounting for differences in early literacy outcomes in low-income families in Zambia -- 14.Home Language and Literacy Environments of Bilingual Children: A Systematic Review -- Part 3 Intervention of HLE -- 15.Interventions with Onscreen Picture Books: Their Capabilities and Limitations -- 16.Maternal mediation and its effects on Reading and Writing -- 17.Interventions in the Home Literacy Environment and Children’s Language and Literacy Skills -- 18.How Effective are Family Literacy Programs? -- 19.Reading and discussing stories together: Does dialogic reading enhance children's language development? -- 20.Conclusion.This book provides a comprehensive and up-to-date overview of the literature on home literacy environment and its association with literacy skills in different languages and contexts. Home literacy environment (HLE), an umbrella term that encompasses various activities parents engage in with their children, has been studied extensively by psychologists, linguists, behavioral geneticists, and educators. However, no systematic effort has been put into synthesizing this growing body of research in a coherent manner, making it difficult for researchers and various stakeholders to understand the key points of past research while keeping up with the latest research findings. To address this need, the first part of the book provides an overview of the current literature on conceptualizations of HLE, covering prominent theoretical models, the measurement of HLE, the potential extension and generalizability of models across contexts, the intersections between home learning environment in literacy, numeracy, and other domains, and the genetic and environmental etiology of literacy development. The second section of the book hosts a wide variety of studies from all over the world, conducted in English-speaking countries (UK, U.S., Canada), Finland, Greece, Turkey, China, Japan, the Philippines and other Southeast Asian countries, and Chile and other Latin American and Caribbean countries, while it includes chapters with both typically-developing children and children at familial risk of dyslexia. The third section of this book offers a comprehensive collection of chapters on intervention studies examining the role of family literacy programs, dialogic reading, and onscreen digital access. Together, the 22 chapters of this book elucidate the complex nature of HLE and provide future research directions and instructional recommendations on how parents and policymakers can improve home literacy practices around the world. As such, this book is valuable for researchers, educators, and other professionals, and the readership ranges from graduate students and scholars to parents and policymakers.Literacy Studies, Perspectives from Cognitive Neurosciences, Linguistics, Psychology and Education,2214-0018 ;26LiteracyAlternative educationEducation and stateNon-formal educationInclusive educationLiteracyAlternative EducationEducation PolicyInformal EducationInclusive EducationLiteracy.Alternative education.Education and state.Non-formal education.Inclusive education.Literacy.Alternative Education.Education Policy.Informal Education.Inclusive Education.374.0124Georgiou Georgeedthttp://id.loc.gov/vocabulary/relators/edtInoue Chihiroedthttp://id.loc.gov/vocabulary/relators/edtMiAaPQMiAaPQMiAaPQBOOK9911002554703321Home Literacy Environment and Literacy Acquisition4384898UNINA