The competitive status of the U.S. pharmaceutical industry : the influences of technology in determining international industrial competitive advantage / / prepared by the Pharmaceutical Panel Committee on Technology and International Economic and Trade Issues, Office of the Foreign Secretary National Academy of Engineering, Commission on Engineering and Technical Systems National Research Council ; Charles C. Edwards, chairman ; Lacy Glenn Thomas, rapporteur |
Edizione | [1st ed.] |
Pubbl/distr/stampa | Washington, D.C. ; ; [Great Britain], : National Academy Press, 1983 |
Descrizione fisica | 1 online resource (114 p.) |
Disciplina | 338.4761510973 |
Altri autori (Persone) | EdwardsCharles C |
Soggetto topico |
Pharmaceutical industry - Technological innovations - United States
Pharmaceutical industry - United States Competition - United States Drugs - United States - Marketing |
ISBN |
1-280-24696-0
9786610246960 0-309-57203-7 0-585-21783-1 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
The Competitive Status of the U.S. Pharmaceutical Industry -- Copyright -- Preface -- Contents -- Summary -- FINDINGS ON THE U.S. COMPETITIVE POSITION -- DETERMINANTS OF NATIONAL PHARMACEUTICAL COMPETITIVE ADVANTAGE -- OPTIONS FOR AMERICAN POLICY -- Trade Options -- Domestic Economic Options -- Regulatory Options -- 1 Overview of U.S. Pharmaceutical Industry -- EMERGENCE OF THE MODERN PHARMACEUTICAL INDUSTRY -- NATURE OF PHARMACEUTICAL COMPETITION -- BENEFITS AND RISKS OF TECHNICAL CHANGE -- OVERVIEW AND LIMITATIONS OF THIS STUDY -- NOTES -- 2 Competitive Position of the U.S. Pharmaceutical Industry -- RESEARCH -- INNOVATION -- PRODUCTION -- SALES -- STRUCTURE -- TRADE -- SUMMARY -- NOTES -- 3 Determinants of National Pharmaceutical Competitive Advantage -- LABOR COSTS -- MARKET GROWTH -- NATIONAL SCIENTIFIC CAPACITY -- GENERAL RELATIVE DECLINE OF U.S. INDUSTRY -- INDUSTRIAL POLICY: REGULATION -- Greater Use of Expert Committees -- Greater Acceptance of Foreign Data -- Less Politicization of Drug Approval Process -- Greater Cooperation between Regulators and Industry -- INDUSTRIAL POLICY: TAXATION -- INDUSTRIAL POLICY: TRADE -- SUMMARY -- NOTES -- 4 New Developments Affecting the Industry -- SCIENTIFIC ADVANCES -- JAPANESE DEVELOPMENTS -- NOTES -- 5 Options for American Industrial Policy -- TRADE OPTIONS -- DOMESTIC ECONOMIC OPTIONS -- REGULATORY OPTIONS -- The IND Process -- Early Clinical Research -- Objectives of Investigational Drug Regulation -- Clinical Development Studies -- Preclearance of Clinical Research -- The NDA Process -- Application of the Standards for Drug Approval -- The NDA Submission and Its Review -- Utilization of Outside Expert Advice -- Application of the Standards for Drug Approval -- FDA Management -- Resources for the New Drug Review Process -- Improving Interactions with Industry.
Tracking the Review Process to Ensure Timeliness -- Conflict of Interest and Expert Advisers -- Improving Interactions with Industry -- NOTES -- 6 Biographical Sketches -- Index. |
Record Nr. | UNINA-9910817036303321 |
Washington, D.C. ; ; [Great Britain], : National Academy Press, 1983 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Economic effects of product liability and other litigation involving the safety and effectiveness of pharmaceuticals [[electronic resource] /] / Steven Garber |
Autore | Garber Steven |
Edizione | [1st ed.] |
Pubbl/distr/stampa | Santa Monica, Calif., : RAND Institute for Civil Justice, 2013 |
Descrizione fisica | 1 online resource (117 p.) |
Disciplina | 338.4761510973 |
Soggetto topico |
Products liability - Drugs - Economic aspects - United States
Pharmaceutical industry - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Cover; Title Page; Copyright; Preface; Contents; Figure and Tables; Summary; Acknowledgments; Abbreviations; CHAPTER ONE: Introduction; CHAPTER TWO: Conceptual Framework for the Analyses; Positive Analysis: Effects of Liability Exposure on Company Decisions and Economic Outcomes; Company Decisions and Economic Outcomes; Conceptualizing Company Decision making; What Determines Whether Companies Respond to Liability Exposure?; What Kinds of Conclusions Are Possible from the Positive Analytic Approach?; Normative Analysis: Economic Efficiency of Effects of Liability Exposure; Economic Efficiency
Identifying Sources of Inefficiency CHAPTER THREE: The Legal and Institutional Settings; Food and Drug Administration Regulation; Preapproval Regulations; Post-Market Regulations; Product-Liability Law for Prescription Drugs; Manufacturing Defects; Design Defects; Warnings Defects; Regulatory Compliance Defenses (RCDs); Other Legal Issues and Practices; Personal-Injury Causation; Class Actions Alleging Personal Injuries; Class Actions Alleging Financial Injuries; Judicial Gatekeeping of Expert Evidence; U.S. Supreme Court Decisions on Sizes of Punitive Damages; Medical Monitoring Claims Congregation and Coordination of Related Lawsuits Settlements of Mass Torts; CHAPTER FOUR: Pharmaceutical Mass Torts During the 1990's and 2000's; Mass Torts Resulting in Especially Large Payouts by Defendants; Fen-Phen Diet Pills; Baycol; Rezulin; Vioxx; Hormone Replacement Therapies-Premarin, Provera, and Prempro; Zyprexa; Mass Tort Attempts Resulting in Substantially Smaller Payouts by Defendants; Norplant; Childhood Vaccines and Autism; Other Mass Tort Attempts That Have Largely Failed for Plaintiffs; Summing Up; Mass Drug-Related Injuries; Mass Torts; Financial Incentives to Avoid Liability Roles of Punitive Damages Controversies About Injury Causation; Transaction Costs of Unsuccessful Mass Tort Attempts; CHAPTER FIVE: Preemption of Pharmaceutical Failure-to-Warn Claims; Federal Preemption Law; Purported Economic Effects of Failure-to-Warn Claims; Economic Arguments Supporting Preemption; Economic Arguments Opposing Preemption; Preemption of Failure-to-Warn Claims for Generic Drugs; Would Failure-to-Warn Litigation Pass a Social Cost-Benefit Test?; Sources of Confusion in the Preemption Debate; The Overall Economic Efficiency of FTW Litigation Is Unknown CHAPTER SIX: Incentives Stemming from Other Litigation Affecting Safety and Effectiveness Actions Brought by the U.S. Department of Justice; State Consumer Protection Acts-Background and Controversies; Safety- and Effectiveness-Related Litigation Brought by State Attorneys General; Safety- and Effectiveness-Related Financial-Injury Litigation Brought by Private Parties; Shareholder Suits Pertaining to Pharmaceutical Safety and Effectiveness; Summing Up; CHAPTER SEVEN: In Conclusion; Major Legal Developments Since 1990; Product Liability for Personal Injury Other Litigation Pertaining to Drug Safety and Effectiveness |
Record Nr. | UNINA-9910220156803321 |
Garber Steven | ||
Santa Monica, Calif., : RAND Institute for Civil Justice, 2013 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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L'introduzione delle biotecnologie nell'industria farmaceutica statunitense / Alfonso Gambardella ; prefazione di Sergio Vaccà |
Autore | GAMBARDELLA, Alfonso |
Pubbl/distr/stampa | Milano : F.Angeli, c1990 |
Descrizione fisica | VIII, 368 p. ; 22 cm |
Disciplina | 338.4761510973 |
Collana | Economia & tecnologia |
Soggetto topico | Industria farmaceutica - Stati Uniti d'America |
ISBN | 88-204-6335-0 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | ita |
Record Nr. | UNISA-990002746750203316 |
GAMBARDELLA, Alfonso | ||
Milano : F.Angeli, c1990 | ||
Materiale a stampa | ||
Lo trovi qui: Univ. di Salerno | ||
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Personalized and precision medicine 2022 / / editor, Anne-Marie Caminade |
Pubbl/distr/stampa | Basel : , : MDPI, , [2023] |
Descrizione fisica | 1 online resource |
Disciplina | 338.4761510973 |
Soggetto topico | Precision medicine |
ISBN | 3-0365-7044-6 |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | About the Editor ix -- Preface to "Personalized and Precision Medicine 2022" xi -- Anne-Marie Caminade -- Personalized and Precision Medicine 2022 -- Reprinted from: J. Pers. Med. 2023, 13, 459, doi:10.3390/jpm13030459 1 -- Giulia Giacomucci, Cristina Polito, Valentina Berti, Sonia Padiglioni, Giulia Galdo and -- Salvatore Mazzeo et al. -- Differences and Similarities in Empathy Deficit and Its Neural Basis between Logopenic and -- Amnesic Alzheimer's Disease -- Reprinted from: J. Pers. Med. 2023, 13, 208, doi:10.3390/jpm13020208 5 -- Katar´ına Hubˇc´ıkov ´a, Tom´aˇs Rak ´us, Alzbeta M ¨uhlb ¨ack, J ´an Benetin, Lucia Bruncvik and ˇ -- Zuzana Petr ´aˇsov ´a et al. -- Psychosocial Impact of Huntington's Disease and Incentives to Improve Care for Affected -- Families in the Underserved Region of the Slovak Republic -- Reprinted from: J. Pers. Med. 2022, 12, 1941, doi:10.3390/jpm12121941 23 -- Viviana Nociti and Marina Romozzi -- Multiple Sclerosis and Autoimmune Comorbidities -- Reprinted from: J. Pers. Med. 2022, 12, 1828, doi:10.3390/jpm12111828 39 -- Karyn G. Robinson, Adam G. Marsh, Stephanie K. Lee, Jonathan Hicks, Brigette Romero -- and Mona Batish et al. -- DNA Methylation Analysis Reveals Distinct Patterns in Satellite Cell-Derived Myogenic -- Progenitor Cells of Subjects with Spastic Cerebral Palsy -- Reprinted from: J. Pers. Med. 2022, 12, 1978, doi:10.3390/jpm12121978 51 -- Sang-Cheol Im, Seong-Wook Seo, Na-Yeon Kang, Hoon Jo and Kyoung Kim -- The Effect of Lumbar Belts with Different Extensibilities on Kinematic, Kinetic, and Muscle -- Activity of Sit-to-Stand Motions in Patients with Nonspecific Low Back Pain -- Reprinted from: J. Pers. Med. 2022, 12, 1678, doi:10.3390/jpm12101678 69 -- Dominik Rak, Alexander J. Nedopil, Eric C. Sayre, Bassam A. Masri and Maximilian Rudert -- Postoperative Inpatient Rehabilitation Does Not Increase Knee Function after Primary Total -- Knee Arthroplasty -- Reprinted from: J. Pers. Med. 2022, 12, 1934, doi:10.3390/jpm12111934 83 -- Minji Kim, Jingwen Li, Sehyang Kim, Wonho Kim, Sun-Hyun Kim and Sung-Min Lee et al. -- Individualized 3D-Printed Bone-Anchored Maxillary Protraction Device for Growth -- Modification in Skeletal Class III Malocclusion -- Reprinted from: J. Pers. Med. 2021, 11, 1087, doi:10.3390/jpm11111087 91 -- Medi Kori, Gullu Elif Ozdemir, Kazim Yalcin Arga and Raghu Sinha -- A Pan-Cancer Atlas of Differentially Interacting Hallmarks of Cancer Proteins -- Reprinted from: J. Pers. Med. 2022, 12, 1919, doi:10.3390/jpm12111919 103 -- Arisa Djurian, Tomohiro Makino, Yeongjoo Lim, Shintaro Sengoku and Kota Kodama -- Dynamic Collaborations for the Development of Immune Checkpoint Blockade Agents -- Reprinted from: J. Pers. Med. 2021, 11, 460, doi:10.3390/jpm11060460 119 -- Victoria Eriksson, Oscar Holmkvist, Ylva Huge, Markus Johansson, Farhood Alamdari and -- Johan Svensson et al. -- A Retrospective Analysis of the De Ritis Ratio in Muscle Invasive Bladder Cancer, with Focus -- on Tumor Response and Long-Term Survival in Patients Receiving Neoadjuvant Chemotherapy -- and in Chemo Na¨ıve Cystectomy Patients-A Study of a Clinical Multicentre Database -- Reprinted from: J. Pers. Med. 2022, 12, 1769, doi:10.3390/jpm12111769 131 -- Harriet Rydell, Anna Ericson, Victoria Eriksson, Markus Johansson, Johan Svensson and -- Viqar Banday et al. -- Thromboembolic Events in Patients Undergoing Neoadjuvant Chemotherapy and Radical -- Cystectomy for Muscle-Invasive Bladder Cancer: A Study of Renal Impairment in Relation to -- Potential Thromboprophylaxis -- Reprinted from: J. Pers. Med. 2022, 12, 1961, doi:10.3390/jpm12121961 143 -- Ishika Mahajan, Aruni Ghose, Deepika Gupta, Manasi Manasvi, Saisha Bhandari and -- Aparimita Das et al. -- COVID-19, Mucormycosis and Cancer: The Triple Threat-Hypothesis or Reality? -- Reprinted from: J. Pers. Med. 2022, 12, 1119, doi:10.3390/jpm12071119 153 -- Kostas Archontogeorgis, Athanasios Voulgaris, Evangelia Nena, Athanasios Zissimopoulos, -- Izolde Bouloukaki and Sophia E. Schiza et al. -- Vitamin D Levels in Patients with Overlap Syndrome, Is It Associated with Disease Severity? -- Reprinted from: J. Pers. Med. 2022, 12, 1693, doi:10.3390/jpm12101693 169 -- Seung-Su Ha and Dong-Kyu Kim -- Diagnostic Efficacy of Ultra-Short Term HRV Analysis in Obstructive Sleep Apnea -- Reprinted from: J. Pers. Med. 2022, 12, 1494, doi:10.3390/jpm12091494 179 -- Keh-Sen Liu, Yao-Shen Tong, Ming-Tsung Lee, Hung-Yu Lin and Min-Chi Lu -- Risk Factors of 30-Day All-Cause Mortality in Patients with Carbapenem-Resistant Klebsiella -- pneumoniae Bloodstream Infection -- Reprinted from: J. Pers. Med. 2021, 11, 616, doi:10.3390/jpm11070616 191 -- Heh-Shiang Sheu, Yi-Ming Chen, Yi-Ju Liao, Chia-Yi Wei, Jun-Peng Chen and Hsueh-Ju Lin -- et al. -- Thiopurine S-Methyltransferase Polymorphisms Predict Hepatotoxicity in -- Azathioprine-Treated Patients with Autoimmune Diseases -- Reprinted from: J. Pers. Med. 2022, 12, 1399, doi:10.3390/jpm12091399 203 -- Simon Reider, Christina Watschinger, Julia L ¨angle, Ulrike Pachmann, Nicole Przysiecki and -- Alexandra Pfister et al. -- Short- and Long-Term Effects of a Prebiotic Intervention with Polyphenols Extracted from -- European Black Elderberry-Sustained Expansion of Akkermansia spp. -- Reprinted from: J. Pers. Med. 2022, 12, 1479, doi:10.3390/jpm12091479 213 -- Anna Russo, Alfonso Reginelli, Giorgia Viola Lacasella, Enrico Grassi, Michele Ahmed -- Antonio Karaboue and Tiziana Quarto et al. -- Clinical Application of Ultra-High-Frequency Ultrasound -- Reprinted from: J. Pers. Med. 2022, 12, 1733, doi:10.3390/jpm12101733 229 -- Valerio Nardone, Emma D'Ippolito, Roberta Grassi, Angelo Sangiovanni, Federico Gagliardi -- and Giuseppina De Marco et al. -- Non-Oncological Radiotherapy: A Review of Modern Approaches -- Reprinted from: J. Pers. Med. 2022, 12, 1677, doi:10.3390/jpm12101677 241 -- Anne-Marie Caminade -- Dendrimers, an Emerging Opportunity in Personalized Medicine? -- Reprinted from: J. Pers. Med. 2022, 12, 1334, doi:10.3390/jpm12081334 261. |
Record Nr. | UNINA-9910683374603321 |
Basel : , : MDPI, , [2023] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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United States pharmaceuticals & healthcare report |
Pubbl/distr/stampa | London : , : Business Monitor International, , 2005- |
Descrizione fisica | 1 online resource |
Disciplina | 338.4761510973 |
Collana |
BMI's Industry survey & forecasts series
BMI's Industry report & forecasts series |
Soggetto topico |
Pharmaceutical industry - United States
Pharmaceutical industry - United States - Forecasting Medical care - United States Medical care - United States - Forecasting Medical care Medical care - Forecasting Pharmaceutical industry Pharmaceutical industry - Forecasting |
Soggetto genere / forma | Periodicals. |
ISSN | 2058-346X |
Formato | Materiale a stampa |
Livello bibliografico | Periodico |
Lingua di pubblicazione | eng |
Record Nr. | UNISA-996208253003316 |
London : , : Business Monitor International, , 2005- | ||
Materiale a stampa | ||
Lo trovi qui: Univ. di Salerno | ||
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