Studiebog
    Fundamentals of Biologicals Regulation

    Fundamentals of Biologicals Regulation

    - Vaccines and Biotechnology Medicines

    Af
    Bog E-bog
    • Format
    • Bog, paperback
    • Engelsk

    Beskrivelse

    Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals.

    Læs hele beskrivelsen
    Detaljer
    • SprogEngelsk
    • Sidetal450
    • Udgivelsesdato01-12-2017
    • ISBN139780128092903
    • Forlag Academic Press Inc
    • FormatPaperback
    Størrelse og vægt
  • Vægt880 g
    • coffee cup img
    10 cm
    book img
    19,1 cm
    23,4 cm

    Findes i disse kategorier...

    Se andre, der handler om...

    Pas Clinical trials Guidelines Informed Consent. Randomized controlled trials Risk assessment Risk management Pharmacology Policy Safety Compliance Orphan drugs Quality Practice Registration Labeling Carcinogenicity M� Biologicals Ethics Committees Ide bla Pharmacovigilance Licensure irb Ec ERC Process validation Phase I/II Public health policy GLP Fast Track Extensions POC IEC Regulatory Convergence Clinical trial ethics Quality-by-design Phase I Adaptive design Cmc Inspections GMP Biosimilars Audits Dmc Inspectorates Preclinical IVD Genetically modified organisms (GMOs) Immunogenicity Compassionate Use Biologics Ich Adverse event Regulatory policy Risk minimization Randomization Clinical Studies Controls IB Regulatory compliance GCP Efficacy Interim Analysis QBD CBE Rec PMA Endpoints Ethics committee RiskMap Blinded Masked Phase 2 Phase II Recalls Institutional Review Board Premarket Notification Animal welfare ethics Adverse event relatedness ­International harmonization ­Managed review process Animal use ethics Accelerated approval Article 58 Benefit/risk animal rule Biological medicine discovery Benefit to risk Biologicals manufacturing Breakthrough therapy CBE30 Biological product characterization. Biotechnological medicinal products Changes being effected Clinical phase Case Report Form Comparability protocol Common technical document (CTD) Clinical Hold Biological medicine development Biologicals regulation CRF Clinical trial approval (CTA) Clinical trial registration Data safety monitoring board Comparability exercise Changes to an approved application Expert Committee on Biological Standardization Class 3 medical device Class 1 medical device Diary card Class 2 medical device DSMB Clinical research ethics review Clinical trial authorization (CTA) Clinical trial registry Good clinical laboratory practices (GCLP) Good pharmacovigilance practices (GVP) Data Monitoring Committee Genetically engineered organism GvP Good laboratory practices Good Laboratory Practices (GLP) Good Clinical Practices (GCP) IND regulations International reference standards In vitro diagnostics Institutional Biosafety Committees (IBCs) Exploratory endpoint Investigational product development Medicinal product discovery Master File Medicinal product development Meetings with regulators Follow-on biologic Medical research ethics review Good pharmacovigilance practices Futility analysis Placebo Control PREA Priority review Periodic benefit risk evaluation report PBRER Good clinical practices Good Manufacturing Practices (GMP) Phase 4 Phase Iv Pre-IND Premarket application Institutional review boards Post-marketing commitments (PMC) Investigational new drug (IND) application Recombinant DNA Advisory Committee (RAC) Refuse-to-file (RTF) regulatory pathways Post-marketing surveillance (PMS) Serious and life-threatening diseases Pre-CTA Primary endpoint Risk/benefit Quality Risk Management International harmonization of regulatory practices Labeling changes Investigational device exemption Similar biotherapeutic products (SBP) Regulatory communications Regulation of clinical trials Risk management plans Risk/benefit decision-making Risk to benefit RMP Human subjects protections. Marketing authorization IND maintenance Similar Biological Medicinal Product Similar biological therapeutics International Council for Harmonisation (ICH) Lot release National Control Laboratories (NCLs) Periodic safety update report Market withdrawals Proof-of-concept PSUR Recombinant medicines Risk minimization action plans Phase 1 Phase 3 nonclinical Prior approval supplement Research ethics oversight Pediatric research equity act Reference biotherapeutic products (RBP) Secondary endpoint AE

    Velkommen til Saxo – din danske boghandel

    Hos os kan du handle som gæst, Saxo-bruger eller Saxo-medlem – du bestemmer selv. Skulle du få brug for hjælp, sidder vores kundeservice-team klar ved både telefonerne og tasterne.

    Om medlemspriser hos Saxo

    For at købe bøger til medlemspris skal du være medlem af Saxo Premium, Saxo Shopping eller Saxo Ung. De første 7 dage er gratis for nye medlemmer. Medlemskabet fornyes automatisk og kan altid opsiges. Læs mere om fordelene ved vores forskellige medlemskaber her.

    Machine Name: SAXO082