02601nam 2200505 450 991027104660332120180713081858.01-118-97113-21-118-97112-41-118-97114-0(CKB)4330000000007784(MiAaPQ)EBC5086821(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 controlElectronic books.Drug development.DrugsTesting.DrugsQuality control.615.19MED071000TEC032000SCI013060bisacshTeasdale AndrewElder David(David P.),Nims Raymond W.MiAaPQMiAaPQMiAaPQBOOK9910271046603321ICH quality guidelines2796933UNINA01900oam 2200577 450 991071391100332120201113082306.0(CKB)5470000002506557(OCoLC)761204301(OCoLC)995470000002506557(EXLCZ)99547000000250655720111115j196904 ua 0engur|||||||||||txtrdacontentcrdamediacrrdacarrierResponse of an infinite elastic plate to axisymmetric initial velocity distributions with application to hypervelocity impact /by Robert J. HaydukWashington, D.C. :National Aeronautics and Space Administration,April 1969.1 online resource (28 pages) illustrationsNASA technical note ;TN D-5118"April 1969."Includes bibliographical references (page 21).Plates (Engineering)Fluid dynamicsAerodynamicsAerodynamicsfastFluid dynamicsfastPlates (Engineering)fastPlates (Engineering)Fluid dynamics.Aerodynamics.Aerodynamics.Fluid dynamics.Plates (Engineering)Hayduk Robert John1941-1401954United States.National Aeronautics and Space Administration,Langley Research Center.OCLCEOCLCEOCLCQOCLCFOCLCQOCLCAOCLCQCOPGPOBOOK9910713911003321Response of an infinite elastic plate to axisymmetric initial velocity distributions with application to hypervelocity impact3471443UNINA01197oam 2200373 450 991071658450332120210609124425.0(CKB)5470000002522307(OCoLC)1255526834(EXLCZ)99547000000252230720210608d1989 ua 0engur|||||||||||txtrdacontentcrdamediacrrdacarrierPower reactor safeguards contigency planning for surface vehicle bombs[Washington, D.C.] :[U.S. Nuclear Regulatory Commission],1989.1 online resource (2 volumes)Generic letter ;no. 89-07"April 28, 1989."Supplement dated August 20, 1989.Nuclear power plantsSafety measuresNuclear terrorismNuclear power plantsSafety measures.Nuclear terrorism.U.S. Nuclear Regulatory Commission,GPOGPOGPOBOOK9910716584503321Power reactor safeguards contigency planning for surface vehicle bombs3250088UNINA