02629nam 2200589Ia 450 991045898760332120200520144314.01-282-99184-197866129918440-7618-5353-7(CKB)2560000000058611(EBL)653871(OCoLC)703137673(SSID)ssj0000486719(PQKBManifestationID)12230303(PQKBTitleCode)TC0000486719(PQKBWorkID)10430349(PQKB)11046213(MiAaPQ)EBC653871(Au-PeEL)EBL653871(CaPaEBR)ebr10447147(CaONFJC)MIL299184(EXLCZ)99256000000005861120070925d2011 uy 0engur|n|---|||||txtccrPresidential lessons in leadership[electronic resource] what executives (and everybody else) can learn from six great American presidents /Ron FelberLanham, MD Hamilton Booksc20111 online resource (235 p.)Description based upon print version of record.0-7618-5352-9 Includes bibliography and index.Contents; Introduction: Presidential Lessons in Leadership; Chapter I. The Big Mistake: Substituting Management for Leadership; Chapter II. Abraham Lincoln: U.S. President, 1861-1865; Chapter III. John F. Kennedy: U.S. President, 1961-1963; Chapter IV. George Washington: U.S President, 1789-1797; Chapter V. Franklin D. Roosevelt: U.S. President, 1933-1945; Chapter VI. Theodore Roosevelt: U.S. President, 1901-1909; Chapter VII. Ronald Reagan: U.S. President, 1981-1989; Chapter VIII. The Transformation: From Fearful Manager to Indomitable Leader; Notes; Bibliography; IndexThis book crystallizes the methods of leadership from America's greatest presidents during moments of personal challenge and turns them into concrete lessons that business leaders, and anyone interested in becoming a more effective leader, can use daily. The presidents include Lincoln, Kennedy, Franklin D. Roosevelt, Teddy Roosevelt, and Reagan.LeadershipPresidentsUnited StatesElectronic books.Leadership.Presidents658.4092973.920922Felber Ron875445MiAaPQMiAaPQMiAaPQBOOK9910458987603321Presidential lessons in leadership1954461UNINA03256nam 2200433 450 991058349910332120180905082214.00-12-814648-60-12-814647-8(CKB)4100000001474195(MiAaPQ)EBC5166123(PPN)230592287(EXLCZ)99410000000147419520180102h20182018 uy 0engurcnu||||||||rdacontentrdamediardacarrierFDA's drug review process and the package label strategies for writing successful FDA submissions /Tom BrodyCambridge, Massachusetts :Academic Press,2018.©20181 online resource (654 pages)Includes index.1. 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.FDA'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 --See back cover.Drug approvalSafety regulationsUnited StatesUnited StatesfastDrug approvalSafety regulations353.00778Brody Tom481636Brody TomMiAaPQMiAaPQMiAaPQBOOK9910583499103321FDA's drug review process and the package label2120361UNINA01237nam0 2200301 i 450 VAN000542320160415102000.41788-8114-561-8IT98 1002820020808d1998 |0itac50 baitaIT|||| |||||ˆLa ‰concezione della giustizia nella vigente Costituzionediritto soggettivo e solidarietàAlberto DonatiNapoli [etc.]Edizioni scientifiche italiane[1998]661 p.24 cm.Diritto soggettivoTeorieVANC003293FIDiritto soggettivoTutela giuridicaVANC003366FINapoliVANL000005340.11Diritto. Filosofia e teoria. Soggetti speciali21DonatiAlbertoVANV001370232997ESI <editore>VANV108662650ITSOL20240329RICABIBLIOTECA DEL DIPARTIMENTO DI GIURISPRUDENZAIT-CE0105VAN00VAN0005423BIBLIOTECA DEL DIPARTIMENTO DI GIURISPRUDENZA00CONS VIII.Eh.89 00 13243 20020812 Concezione della giustizia nella vigente costituzione625381UNICAMPANIA