LEADER 00917nam0-22003011i-450- 001 990003150570403321 035 $a000315057 035 $aFED01000315057 035 $a(Aleph)000315057FED01 035 $a000315057 100 $a20000920d--------km-y0itay50------ba 101 0 $aita 102 $aIT 200 1 $aOutput Fluctuations in the United States$eWhat Has Changed Since the Early 1980s?$fMargaret M. McConnell, Gabriel Perez Quiros 225 1 $aFederal Reserve Bank of New York Staff Reports$v98.41 610 0 $aReddito nazionale 610 0 $aStati Uniti$aEconomia pubblica$aStudi generali 676 $aF/1.221 676 $aF/2.1 702 1$aMcConnell,$bMargaret M. 801 0$aIT$bUNINA$gRICA$2UNIMARC 901 $aBK 912 $a990003150570403321 952 $aPaper$fSES 959 $aSES 996 $aOutput Fluctuations in the United States$9456342 997 $aUNINA DB $aING01 LEADER 03256nam 2200433 450 001 9910583499103321 005 20180905082214.0 010 $a0-12-814648-6 010 $a0-12-814647-8 035 $a(CKB)4100000001474195 035 $a(MiAaPQ)EBC5166123 035 $a(PPN)230592287 035 $a(EXLCZ)994100000001474195 100 $a20180102h20182018 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 10$aFDA's drug review process and the package label $estrategies for writing successful FDA submissions /$fTom Brody 210 1$aCambridge, Massachusetts :$cAcademic Press,$d2018. 210 4$dİ2018 215 $a1 online resource (654 pages) 300 $aIncludes index. 327 $a1. Introduction to regulated clinical trials -- 2. FDA's decision-making process when assessing ambiguous data -- 3. Food effect studies -- 4. Dose modification and dose titration -- 5. Contraindications -- 6. Animal studies -- 7. Drug-drug interactions: part one (small molecule drugs) -- 8. Drug-drug interactions: part two (therapeutic proteins) -- 9. Immunosuppression, drug-induced hypersensitivity reactions, and drug-induced autoimmune reactions -- 10. Drug class analysis -- 11. Relatedness -- 12. Adjudication of clinical data -- 13. Coding -- 14. Pooling. 330 $aFDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label --$cSee back cover. 606 $aDrug approval$xSafety regulations$zUnited States 607 $aUnited States$2fast 615 0$aDrug approval$xSafety regulations 676 $a353.00778 700 $aBrody$b Tom$0481636 702 $aBrody$b Tom 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910583499103321 996 $aFDA's drug review process and the package label$92120361 997 $aUNINA LEADER 01043nam 2200373 450 001 9910811838503321 005 20200320142653.0 010 $a1-4396-6399-8 035 $a(CKB)5120000000100687 035 $a(MiAaPQ)EBC5640207 035 $a(EXLCZ)995120000000100687 100 $a20190619d2018 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aLouisville's Alma Kellner mystery /$fShawn M. Herron 210 1$aCharleston, South Carolina :$cHistory Press,$d2018. 215 $a1 online resource (148 pages) 311 $a1-4671-3816-9 606 $aMurder$zKentucky 607 $aKentucky$zLouisville$2fast 608 $aHistory.$2fast 615 0$aMurder 676 $a364.152309769 700 $aHerron$b Shawn M.$01703436 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910811838503321 996 $aLouisville's Alma Kellner mystery$94088614 997 $aUNINA