LEADER 05188nam 22006494a 450 001 9910144557003321 005 20210901104915.0 010 $a1-280-85409-X 010 $a9786610854097 010 $a3-527-60753-6 010 $a3-527-60700-5 035 $a(CKB)1000000000377170 035 $a(EBL)482272 035 $a(OCoLC)70054438 035 $a(SSID)ssj0000140421 035 $a(PQKBManifestationID)11132252 035 $a(PQKBTitleCode)TC0000140421 035 $a(PQKBWorkID)10053445 035 $a(PQKB)11112891 035 $a(MiAaPQ)EBC482272 035 $a(EXLCZ)991000000000377170 100 $a20060628d2005 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aDNA pharmaceuticals$b[electronic resource] $eformulation and delivery in gene therapy, DNA vaccination and immunotherapy /$fedited by Martin Schleef 210 $aWeinheim $cWiley-VCH$dc2005 215 $a1 online resource (277 p.) 300 $aDescription based upon print version of record. 311 $a3-527-31187-4 320 $aIncludes bibliographical references and index. 327 $aDNA Pharmaceuticals; Preface; Contents; List of Contributors; Abbreviations; 1 DNA Vaccines - An Overview; 1.1 Rationale for DNA Vaccines; 1.2 Preclinical Proof of Concept; 1.3 Clinical Trials; 1.4 Second-Generation Vaccines; 1.5 Conclusions; References; 2 DNA as a Pharmaceutical - Regulatory Aspects; 2.1 Introduction; 2.2 Quality Requirements for DNA used as a Gene Therapy Product; 2.2.1 Introduction; 2.2.2 Production and Purification; 2.2.2.1 Raw Materials; 2.2.2.2 Antibiotics; 2.2.2.3 Solvents; 2.2.2.4 Fermentation; 2.2.2.5 Purification; 2.2.3 Cell Banking System Procedures 327 $a2.2.3.1 Generation and Characterization of Master and Working Cell Banks2.2.4 Product Characterization and Quality Criteria; 2.2.4.1 Identity; 2.2.4.2 Purity; 2.2.4.3 Adventitious Agents; 2.2.4.4 Potency; 2.3 Safety Studies for Clinical Trials; 2.3.1 General Considerations; 2.3.2 Conduct of Preclinical Safety Studies; 2.3.2.1 Regulations; 2.3.2.2 Design of an Appropriate Toxicology Program; 2.3.2.3 Single- and Repeat-Dose Toxicity Studies; 2.3.2.4 Safety of the Formulated Plasmid DNA; 2.3.2.5 Specific Safety Considerations; 2.3.2.6 Choice of Animal Model; 2.4 Special Issues 327 $a2.4.1 Comparability of Plasmid Gene Therapy Products2.4.2 Mixed Plasmid Preparations; 2.4.3 Plasmid Molecular Structure; 2.5 Biosafety Issues and Environmental Risk Assessment; References; 3 From Bulk to Delivery: Plasmid Manufacturing and Storage; 3.1 Introduction; 3.1.1 Gene Therapy; 3.1.2 DNA Vaccination; 3.2 Manufacturing of Plasmid DNA; 3.2.1 Bacterial Cultivation; 3.2.2 Plasmid DNA Purification; 3.2.3 Innovative Aspects in Plasmid Manufacturing; 3.3 Quality Control of Plasmid DNA Vectors; 3.3.1 Proteins, Ribonucleic Acid, and Lipopolysaccharides; 3.3.2 Chromosomal DNA 327 $a3.3.3 Plasmid Identity3.3.4 Plasmid Topology (Structural Homogeneity); 3.4 Plasmid Stability during Storage and Application; 3.4.1 Long-Term Stability of Plasmid DNA; 3.4.2 Lyophilization for Long-Term Storage; 3.4.3 Stability during Application; 3.5 Future Developments; References; 4 Minimized, CpG-Depleted, and Methylated DNA Vectors: Towards Perfection in Nonviral Gene Therapy; 4.1 Introduction; 4.2 The Mammalian Immune System as a Barrier to Nonviral Gene Delivery; 4.3 Strategies to Minimize DNA Vectors 327 $a4.3.1 Excision of a DNA Fragment Containing a Transgene Expression Cassette from Plasmid DNA4.3.2 Intramolecular Site-Specific Recombination Within a Bacterial Plasmid; 4.3.3 Synthesis of Minimized DNA Vectors by PCR; 4.3.4 Improvement of Minimized DNA Vector Yield and Purity; 4.4 Depletion of CpG Dinucleotides in the Bacterial Vector Backbone; 4.5 Methylation of CpG Dinucleotides in Plasmid DNA; 4.6 Towards an Ideal Nonviral Vector; 4.7 Conclusion; References; 5 Localized Nucleic Acid Delivery: A Discussion of Selected Methods; 5.1 Foreword; 5.2 Nucleic Acid Delivery - What For? 327 $a5.3 Nucleic Acid Delivery - How? 330 $aWith its focus on a completely novel class of pharmaceuticals, this book collates the hitherto scarce literature about DNA drug formulation keenly desired by biotechnologists, molecular biologists and pharmacists, as well as those working in the biotechnological and pharmaceutical industries.As such, this volume presents a wide range of gene delivery systems needed for different therapeutic applications. It fills the gap between research and clinical trials and describes pharmaceutical fundamentals for the development of efficient DNA pharmaceuticals. 606 $aDNA vaccines 606 $aGene therapy 606 $aImmunotherapy 608 $aElectronic books. 615 0$aDNA vaccines. 615 0$aGene therapy. 615 0$aImmunotherapy. 676 $a615.372 676 $a616.0796 701 $aSchleef$b M$g(Martin)$0872773 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910144557003321 996 $aDNA pharmaceuticals$92197281 997 $aUNINA LEADER 03954nam 2200709 a 450 001 9910345146903321 005 20231206213738.0 010 $a1-282-12977-5 010 $a1-282-93547-X 010 $a9786612935473 010 $a9786612129773 010 $a1-4008-2804-X 024 7 $a10.1515/9781400828043 035 $a(CKB)1000000000756308 035 $a(EBL)445438 035 $a(OCoLC)336426968 035 $a(SSID)ssj0000136614 035 $a(PQKBManifestationID)11151401 035 $a(PQKBTitleCode)TC0000136614 035 $a(PQKBWorkID)10084248 035 $a(PQKB)10303493 035 $a(MdBmJHUP)muse36500 035 $a(DE-B1597)446718 035 $a(OCoLC)979835069 035 $a(DE-B1597)9781400828043 035 $a(Au-PeEL)EBL445438 035 $a(CaPaEBR)ebr10284073 035 $a(CaONFJC)MIL293547 035 $a(Au-PeEL)EBL4968530 035 $a(CaONFJC)MIL212977 035 $a(OCoLC)746472030 035 $a(MiAaPQ)EBC445438 035 $a(MiAaPQ)EBC4968530 035 $a(EXLCZ)991000000000756308 100 $a20061013d2007 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aDemocratic breakdown and the decline of the Russian military /$fZoltan Barany 205 $aCourse Book 210 $aPrinceton $cPrinceton University Press$dc2007 215 $a1 online resource (xi, 247 pages) 300 $aDescription based upon print version of record. 311 1 $a0-691-12896-0 320 $aIncludes bibliographical references (p. [193]-237) and index. 327 $aIntroduction -- The tragedy and symbolism of the Kursk -- Assessing decay: the Soviet/Russian military, 1985-2006 -- Explaining the military's political presence -- The elusive defense reform -- Civil-military relations and superpresidentialism -- Conclusion. 330 $aWhy have Russian generals acquired an important political position since the Soviet Union's collapse while at the same time the effectiveness of their forces has deteriorated? Why have there been no radical defense reforms in Russia since the end of the cold war, even though they were high on the agenda of the country's new president in 2000? Democratic Breakdown and the Decline of the Russian Military explains these puzzles as it paints a comprehensive portrait of Russian military politics. Zoltan Barany identifies three formative moments that gave rise to the Russian dilemma. The first was Gorbachev's decision to invite military participation in Soviet politics. The second was when Yeltsin acquiesced to a new political system that gave generals a legitimate political presence. The third was when Putin not only failed to press for needed military reforms but elevated numerous high-ranking officers to prominent positions in the federal administration. Included here are Barany's insightful analysis of crisis management following the sinking of the Kursk submarine, a systematic comparison of the Soviet/Russian armed forces in 1985 and the present, and compelling accounts of the army's political role, the elusive defense reform, and the relationship between politicians and generals. Barany offers a rare look at the world of contemporary military politics in an increasingly authoritarian state. Destined to become a classic in post-Soviet studies, this book reminds us of the importance of the separation of powers as a means to safeguard democracy. 606 $aCivil-military relations$zRussia (Federation) 607 $aRussia (Federation)$xPolitics and government$y1991- 615 0$aCivil-military relations 676 $a322/.50947 686 $a89.81$2bcl 700 $aBarany$b Zoltan D$0532168 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910345146903321 996 $aDemocratic breakdown and the decline of the Russian military$92484877 997 $aUNINA