02600nam 2200505 450 991083021540332120230814235023.01-118-97113-21-118-97112-41-118-97114-0(CKB)4330000000007784(MiAaPQ)EBC5086821(OCoLC)979994458(EXLCZ)99433000000000778420171030h20182018 uy 0engurcnu||||||||rdacontentrdamediardacarrierICH quality guidelines an implementation guide /edited by Andrew Teasdale, AstraZeneca, London, United Kingdom, David Elder, Consultant (fGSK), Hertford, Hertfordshire, SG14 2DE, United Kingdom, Raymond W. Nims, RMC Pharmaceutical Solutions, Inc., Longmont, CO, USAHoboken, New Jersey :Wiley,2018.©20181 online resource (722 pages) illustrations (some color)1-118-97111-6 Includes bibliographical references at the end of each chapters and index."Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies. Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines. Uses case studies to help readers understand and apply ICH guidelines. Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines. Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)"--Provided by publisher.Drug developmentDrugsTestingDrugsQuality controlDrug development.DrugsTesting.DrugsQuality control.615.19MED071000TEC032000SCI013060bisacshTeasdale AndrewElder David(David P.),Nims Raymond W.MiAaPQMiAaPQMiAaPQBOOK9910830215403321ICH quality guidelines4032801UNINA04868nam 2200649 450 991082649320332120230803212636.092-2-129099-9(CKB)3710000000346953(EBL)1936511(SSID)ssj0001472819(PQKBManifestationID)11825040(PQKBTitleCode)TC0001472819(PQKBWorkID)11436372(PQKB)11534480(MiAaPQ)EBC1936511(Au-PeEL)EBL1936511(CaPaEBR)ebr11018245(OCoLC)902958100(EXLCZ)99371000000034695320150222h20142014 uy 0engurcnu||||||||txtccrSpain growth with Jobs /International Labour OfficeGeneva, Switzerland :International Labour Office,2014.©20141 online resource (220 p.)Studies in Growth with EquityDescription based upon print version of record.92-2-129098-0 Includes bibliographical references.FOREWORD; ACKNOWLEDGEMENTS; TABLE OF CONTENTS; FIGURES; TABLES; BOXES; LIST OF ABBREVIATIONS; EXECUTIVE SUMMARY AND POLICY RECOMMENDATIONS; 1. ECONOMIC AND LABOUR MARKET PERFORMANCE: SIGNS OF RECOVERY; INTRODUCTION; A. MACROECONOMIC TRENDS: A REBOUND IN ECONOMIC ACTIVITY; Figure 1.1 Real GDP growth, Q1 2007 to Q1 2014; Figure 1.2 Contribution to GDP growth by main component; Figure 1.3 Share of exports to euro area and non-euro area countries; Figure 1.4 Contribution to export growth by type of product in 2013; Figure 1.5 Change in gross fixed capital formation as a percentage of GDPFigure 1.6 Public deficit/surplus and debt as a share of GDPB. LABOUR MARKET PERFORMANCE; Figure 1.7 GDP and employment growth in selected countries; Figure 1.8 Employment losses by sector; Figure 1.9 Dependent employment losses by type of contract; Figure 1.10 Share of long-term unemployment in total unemployment; Box 1.1 Poverty and inequality in Spain; Table 1.1 Labour market performance in Q2 2014; Figure 1.11 Percentage change in the total number of operating enterprises and self-employed workers; Figure 1.12 Growth rate of employment by industry activity in 2013C. CONCLUDING REMARKS REFERENCES; 2. PRODUCTIVITY AND COMPETITIVENESS: TRENDS, DETERMINANTS AND POSSIBLE WAYS FORWARD; INTRODUCTION; A. FACTORS UNDERLYING THE TRENDS IN PRODUCTIVITY AND COMPETITIVENESS; Box 2.1 Unit labour cost (ULC) and real effective exchange rate (REER):; Figure 2.1 Decomposition of changes in REER between 1999 and 2009; Figure 2.2 GDP growth by factor, 2007-2011; Figure 2.3 Growth rates of nominal wages in selected countries; Figure 2.4 Average growth rate of real wages by economic sector; Figure 2.5 ULC-based REER in selected countries, 2000-2014B. TIGHT CREDIT MARKETS: EFFECTS ON INVESTMENTS AND EMPLOYMENT Figure 2.6 Change in bank credit to non-financial corporations as a percentage of GDP in selected EU countries, 2003-2013; Figure 2.7 Interest rates on loans to non-financial corporations up to 0.25 million; Figure 2.8 Access to finance and employment in SMEs, 2009-2011; C. FIRMS' DEMOGRAPHY AND BUSINESS ENVIRONMENT; Figure 2.9 Enterprise creation; Figure 2.10 Survival rates at one and five years after firms' creation, 2009 and 2011; Figure 2.11 Employment growth in newly constituted enterprises, 2011Box 2.2 The regulation of retail trade Box 2.3 The Spanish electricity sector; D. POLICY CONSIDERATIONS; Box 2.4 Starting a business:; Table 2.1 Comparative performances between firms with and without PE and VC financing; Box 2.5 The role of PE and VC in determining companies' performances; Table 2.2 Policy response to improve SMEs' access to finance; Figure 2.12 Labour market effects of a decrease in bank loan interest rates; REFERENCES; 3. RE-ORIENTING LABOUR MARKET POLICIES FOR IMPROVED EMPLOYMENT AND SOCIAL OUTCOMES; INTRODUCTIONA. JOB QUALITY, POVERTY AND LABOUR MARKET POLARIZATION: A GROWING CONCERNThis report points to a number of areas where the Spanish Government and social partners could take action together to solidify recent gains and build a new path to more and better jobs.Studies in Growth with EquityJob creationSpainManpower policySpainLabor marketSpainJob creationManpower policyLabor market331.120946International Labour Office.MiAaPQMiAaPQMiAaPQBOOK9910826493203321Spain520834UNINA