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Development of medications for the treatment of opiate and cocaine addictions [[electronic resource] ] : issues for the government and private sector / / Carolyn E. Fulco, Catharyn T. Liverman, and Laurence E. Earley, editors ; Committee to Study Medication Development and Research at the National Institute on Drug Abuse, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine
| Development of medications for the treatment of opiate and cocaine addictions [[electronic resource] ] : issues for the government and private sector / / Carolyn E. Fulco, Catharyn T. Liverman, and Laurence E. Earley, editors ; Committee to Study Medication Development and Research at the National Institute on Drug Abuse, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine |
| Pubbl/distr/stampa | Washington, DC, : National Academy Press, 1995 |
| Descrizione fisica | xvii, 250 p. : ill |
| Disciplina | 616.86/32061 |
| Altri autori (Persone) |
FulcoCarolyn
LivermanCatharyn T EarleyLaurence E |
| Soggetto topico |
Drug addiction - Treatment
Cocaine abuse - Treatment Substance abuse - Treatment |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-19299-2
9786610192991 0-309-58791-3 0-585-02541-X |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910456005403321 |
| Washington, DC, : National Academy Press, 1995 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of medications for the treatment of opiate and cocaine addictions [[electronic resource] ] : issues for the government and private sector / / Carolyn E. Fulco, Catharyn T. Liverman, and Laurence E. Earley, editors ; Committee to Study Medication Development and Research at the National Institute on Drug Abuse, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine
| Development of medications for the treatment of opiate and cocaine addictions [[electronic resource] ] : issues for the government and private sector / / Carolyn E. Fulco, Catharyn T. Liverman, and Laurence E. Earley, editors ; Committee to Study Medication Development and Research at the National Institute on Drug Abuse, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine |
| Pubbl/distr/stampa | Washington, DC, : National Academy Press, 1995 |
| Descrizione fisica | xvii, 250 p. : ill |
| Disciplina | 616.86/32061 |
| Altri autori (Persone) |
FulcoCarolyn
LivermanCatharyn T EarleyLaurence E |
| Soggetto topico |
Drug addiction - Treatment
Cocaine abuse - Treatment Substance abuse - Treatment |
| ISBN |
0-309-17652-2
1-280-19299-2 9786610192991 0-309-58791-3 0-585-02541-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778654103321 |
| Washington, DC, : National Academy Press, 1995 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of medications for the treatment of opiate and cocaine addictions : issues for the government and private sector / / Carolyn E. Fulco, Catharyn T. Liverman, and Laurence E. Earley, editors ; Committee to Study Medication Development and Research at the National Institute on Drug Abuse, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine
| Development of medications for the treatment of opiate and cocaine addictions : issues for the government and private sector / / Carolyn E. Fulco, Catharyn T. Liverman, and Laurence E. Earley, editors ; Committee to Study Medication Development and Research at the National Institute on Drug Abuse, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, DC, : National Academy Press, 1995 |
| Descrizione fisica | xvii, 250 p. : ill |
| Disciplina | 616.86/32061 |
| Altri autori (Persone) |
FulcoCarolyn
LivermanCatharyn T EarleyLaurence E |
| Soggetto topico |
Drug addiction - Treatment
Cocaine abuse - Treatment Substance abuse - Treatment |
| ISBN |
0-309-17652-2
1-280-19299-2 9786610192991 0-309-58791-3 0-585-02541-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Development of Medications for the Treatment of Opiate and Cocaine Addictions: Issues for the Government and Private Sector -- Copyright -- Acknowledgments -- Preface -- Note to the Reader -- Contents -- Executive Summary -- STATE OF THE SCIENTIFIC KNOWLEDGE ON ADDICTION -- NIDA'S MEDICATIONS DEVELOPMENT DIVISION -- EFFECTIVENESS OF TREATMENT -- TREATMENT FINANCING -- TRAINING AND EDUCATION -- FEDERAL REGULATORY ISSUES -- Food and Drug Administration -- Drug Enforcement Administration -- STATE REGULATORY ISSUES -- Interim Actions -- Long-Term Actions -- MARKET OBSTACLES AND CREATING INCENTIVES -- Size of the Market -- Drug Pricing and Intellectual Property Rights -- Societal Stigma -- NEED FOR FEDERAL LEADERSHIP -- CONCLUSIONS -- OPTIONS FOR FURTHER CONSIDERATION -- REFERENCES -- 1 Introduction -- PUBLIC-HEALTH REPERCUSSIONS OF ILLICIT DRUG USE -- Health Consequences: Violence -- Health Consequences: AIDS -- Health Consequences: Tuberculosis -- Health Consequences: Drug-exposed Infants -- ECONOMIC COSTS OF ILLICIT DRUG USE TO SOCIETY -- EXTENT OF ILLICIT DRUG USE -- ROLE OF PHARMACOTHERAPY -- REFERENCES -- 2 Overview of the State of Scientific Knowledge Concerning Drug Addiction -- CONCEPTS OF DRUG ADDICTION -- BIOLOGICAL CORRELATES AND PSYCHOPHARMACOLOGY OF ADDICTION -- Opiate Addiction -- Cocaine Addiction -- MDD AND STRATEGIES FOR THE DISCOVERY OF A COCAINE MEDICATION: DESCRIPTION AND CRITICAL ANALYSIS -- Introduction -- Source of Compounds -- Medication Preclinical Screening -- In Vitro Screen-Receptors and Mechanisms of Action -- In Vivo Screen-Behavioral Tests -- Specific Conclusions and Recommendations for the MDD -- Clinical Trials -- Human Behavioral Models -- CONCLUSIONS AND RECOMMENDATIONS -- REFERENCES -- 3 Assessment of the Medications Development Division -- STRUCTURE AND FUNCTIONS OF THE MEDICATIONS DEVELOPMENT DIVISION.
Mission and History -- Research Focus on Opiates and Cocaine -- Program Objectives -- Organizational Structure -- Budget Process -- Resources and Funding Instruments -- Types of Grants and Contracts -- Interagency Agreements -- CRADAs -- Screening Agreements -- Training -- RELATIONSHIPS WITH OTHER FEDERAL AGENCIES AND THE PRIVATE SECTOR -- Food and Drug Administration -- Drug Enforcement Administration -- Office of Protection from Research Risks -- Pharmaceutical Industry -- ASSESSMENT OF THE MEDICATIONS DEVELOPMENT DIVISION -- Staff and Resources -- Drug-Discovery Programs -- Clinical Trials -- Clinical-Research Training -- Relationships with Regulatory Agencies -- Interaction with the Private Sector -- SUMMARY -- CONCLUSIONS AND RECOMMENDATIONS -- REFERENCES -- 4 Treatment Setting and Effectiveness -- TREATMENT SETTING -- Opiate Addiction -- Cocaine Addiction -- DEMOGRAPHIC AND FINANCIAL PROFILE -- Opiate-Dependent Patients -- Cocaine-Dependent Patients -- TREATMENT EFFECTIVENESS AND COST-EFFECTIVENESS -- Methadone Maintenance Treatment -- Effectiveness -- Cost-Effectiveness -- Cocaine Addiction Treatment -- Effectiveness -- Cost-Effectiveness -- CONCLUSIONS AND RECOMMENDATION -- REFERENCES -- 5 Treatment Financing and Trends in Health Insurance -- FINANCING OF TREATMENT -- Financing the Treatment of Opiate Addiction -- Financing the Treatment of Cocaine Addiction -- FINANCING OF LAAM FOR THE TREATMENT OF OPIATE ADDICTION -- IMPACT OF HEALTH INSURANCE TRENDS ON MEDICATIONS DEVELOPMENT -- Trends in Drug Abuse Treatment Benefits -- REFERENCES -- 6 Training and Education -- EXPANDING THE CORE OF RESEARCHERS AND CLINICIANS -- Training Programs -- Fellowships -- Certification -- Conclusions and Recommendations -- INCREASING KNOWLEDGE AND SKILLS AMONG PRIMARY CARE PHYSICIANS -- Required Education in Medical Schools -- Residency Training. Continuing Education -- Conclusions and Recommendations -- COMPREHENSIVE DRUG ABUSE CENTERS -- Proposed Model -- Existing Research and Training Centers -- CSAT Centers -- NIDA Research Centers -- Conclusions and Recommendations -- SUMMARY -- REFERENCES -- 7 Federal Laws and Regulations -- CREATION OF A DRUG BY THE PHARMACEUTICAL INDUSTRY -- FOOD AND DRUG ADMINISTRATION -- Recent Initiatives to Expedite Availability of New Drugs -- Market Exclusivity and Orphan Drug Status -- FDA Guidelines on Evaluation of Anti-Addiction Drugs -- DRUG ENFORCEMENT ADMINISTRATION -- Scheduling -- Quotas -- Regulatory Authority Over Anti-Addiction Drugs In Development -- CONCLUSIONS -- REFERENCES -- 8 State Laws and Regulations -- STATE REGULATORY LANDSCAPE -- Scheduling -- Treatment -- Admission Criteria -- Staffing Requirements -- Patient Registries -- Drug Screening -- Medication Take-Home Policies -- Clinical Research -- LAAM: A CASE STUDY -- Federal Regulations -- State Regulations -- Scheduling/Rescheduling -- Treatment Regulations -- Clinic Approval -- CONCLUSIONS -- RECOMMENDATIONS -- Interim Actions -- Long-Term Actions -- REFERENCES -- 9 Market Obstacles and Creating Incentives -- MARKET OBSTACLES TO PRIVATE-SECTOR INVESTMENT -- Nature and Size of the Market -- Drug Pricing and Intellectual Property Rights -- Societal Stigma -- Clinical Research on Anti-Addiction Medications -- Product Liability -- NEED FOR FEDERAL LEADERSHIP -- CONCLUSIONS -- OPTIONS FOR FURTHER CONSIDERATION -- REFERENCES -- Appendix A Acknowledgements -- Appendix B Organization and Mission Statements of NIDA's Medications Development Division and Its... -- MEDICATIONS DEVELOPMENT DIVISION MISSION STATEMENT -- Biometrics Branch Mission Statement -- Chemistry and Pharmaceutics Branch Mission Statement -- Clinical Trials Branch Mission Statement. Pharmacology and Toxicology Branch Mission Statement -- Regulatory Affairs Branch Mission Statement -- Appendix C Diagnostic Criteria for Psychoactive Substance Dependence -- Appendix D Survey of Pharmaceutical Companies -- ATTACHMENT 1 -- ATTACHMENT 2 -- Appendix E Model Federal Programs in Pharmaceutical R& -- D -- ANTIEPILEPTIC DRUG DEVELOPMENT PROGRAM -- Background -- Elements of Success -- NATIONAL CANCER INSTITUTE CANCER-DRUG DISCOVERY AND DEVELOPMENT PROGRAMS -- Background -- Preclinical Research -- Clinical Research -- Elements of Success -- NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES DRUG DISCOVERY AND DEVELOPMENT PROGRAMS -- Background -- Preclinical Research -- Clinical Research -- Elements of Success -- REFERENCES -- Appendix F Workshop Agenda and Participants -- WORKSHOP AGENDA -- PARTICIPANT LIST -- Appendix G Health Care Reform Legislation -- UNIVERSALITY OF COVERAGE -- PRESCRIPTION DRUG BENEFITS -- DRUG ABUSE TREATMENT BENEFITS -- INSURANCE REFORM -- FINANCING HEALTH CARE REFORM AND THE FATE OF MEDICAID -- CONCLUSIONS -- REFERENCES -- Appendix H Acronyms. |
| Record Nr. | UNINA-9910828852203321 |
| Washington, DC, : National Academy Press, 1995 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Food and Drug Administration advisory committees [[electronic resource] /] / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors
| Food and Drug Administration advisory committees [[electronic resource] /] / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1992 |
| Descrizione fisica | xii, 226 p. : ill |
| Disciplina | 353.0077/8 |
| Altri autori (Persone) |
RettigRichard A
EarleyLaurence E MerrillRichard A |
| Soggetto topico | Public health advisory groups - United States - Evaluation |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-24686-3
9786610246861 0-309-58520-1 0-585-08550-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910455935203321 |
| Washington, D.C., : National Academy Press, 1992 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Food and Drug Administration advisory committees [[electronic resource] /] / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors
| Food and Drug Administration advisory committees [[electronic resource] /] / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1992 |
| Descrizione fisica | xii, 226 p. : ill |
| Disciplina | 353.0077/8 |
| Altri autori (Persone) |
RettigRichard A
EarleyLaurence E MerrillRichard A |
| Soggetto topico | Public health advisory groups - United States - Evaluation |
| ISBN |
1-280-24686-3
9786610246861 0-309-58520-1 0-585-08550-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778795803321 |
| Washington, D.C., : National Academy Press, 1992 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Food and Drug Administration advisory committees / / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors
| Food and Drug Administration advisory committees / / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1992 |
| Descrizione fisica | xii, 226 p. : ill |
| Disciplina | 353.0077/8 |
| Altri autori (Persone) |
RettigRichard A
EarleyLaurence E MerrillRichard A |
| Soggetto topico | Public health advisory groups - United States - Evaluation |
| ISBN |
1-280-24686-3
9786610246861 0-309-58520-1 0-585-08550-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Food and Drug Administration Advisory Committees -- Copyright -- Preface -- NOTES -- Acknowledgments -- Contents -- List of Abbreviations -- Summary -- The Roles of FDA Advisory Committees -- Practical Limits on Advisory Committees -- COMMITTEE MEMBERSHIP -- Nomination Criteria -- Recruitment Procedures -- Consumer Members -- Appointment Authority -- Administrative Responsibility for Appointments -- COMMITTEE INTEGRITY -- Options Requiring Legislation -- Options Available within Existing Authority -- COMMITTEE OPERATIONS -- Scheduling Meetings -- Meeting Preparation -- General Criteria for Setting the Agenda -- Setting Specific Agendas -- Timely Distribution of Materials -- Summaries of Materials Sent to Advisory Committees -- Use of Primary Reviewers -- Communications Issues -- Conducting an Advisory Committee Meeting -- Allocation and Control of Agenda Time -- Electronic Coverage of Meetings -- Voting -- Agency Neutrality -- Custom Tailoring of Committee Membership -- Meeting Follow-up -- ORGANIZATION AND MANAGEMENT -- System Management -- Compensation -- Orientation and Training -- AGENCY MANAGEMENT AND ACCOUNTABILITY -- Agency Management -- Agency Accountability -- A CONCLUDING RECOMMENDATION -- NOTES -- 1 Introduction -- ORIGINS OF THE STUDY -- STUDY OBJECTIVES -- SCOPE OF THE STUDY -- THE ROLES OF FDA ADVISORY COMMITTEES -- PRACTICAL LIMITS ON THE USE OF ADVISORY COMMITTEES -- THE FEDERAL ADVISORY COMMITTEE ACT -- STUDY METHODS -- REPORT ORGANIZATION -- A NOTE ON CROSS-NATINOAL COMPARISONS -- APPENDIX -- NOTE -- 2 Historical Evolution of FDA Advisory Committees -- DRUGS -- Drug Efficacy Study -- Over-the-Counter Drugs -- Prescription Drug Review -- Summary -- BIOLOGICS -- MEDICAL DEVICES -- The Cooper Report -- The Medical Device Amendments of 1976 -- NIH STUDY SECTIONS -- SUMMARY -- NOTES -- 3 The FDA Advisory Committee System.
THE PRODUCT EVALUATION PROCESS -- The Drug Evaluation Process -- The Biologics Approval Process -- The Device Approval Process -- AGENCY WORKLOAD AND ADVISORY COMMITTEES -- OFFICIAL PURPOSES OF ADVISORY COMMITTEES -- The FDA Regulations -- The NDA Rewrite -- Medical Device Statutes -- FDA Advisory Committee Charters -- THE USES OF ADVISORY COMMITTEES -- Variations Among Centers -- Center Workload and Stage of Advisory Committee Use -- Other Means of Seeking Advice -- SUMMARY -- NOTES -- 4 Recurring Issues -- MAJOR PRIOR REPORTS -- The Fountain Committee Report (1976) -- The Dorsen Committee Report (1977) -- The McMahon Commission Report (1982) -- The Lasagna Committee Report (1990) -- Other Reports -- THE GOLDFISH BOWL -- Congressional Oversight -- Media Coverage -- The Financial Community -- CONCLUSIONS -- NOTES -- 5 Committee Membership -- NOMINATION CRITERIA -- General and Specific Criteria -- Diversity Objectives -- Balance -- Implications -- RECRUITMENT PROCEDURES -- CONSUMER MEMBERS -- APPOINTMENT AUTHORITY -- ADMINISTRATIVE RESPONSIBILITY FOR APPOINTMENTS -- 6 Ensuring Committee Integrity -- FINANCIAL CONFLICT OF INTEREST -- THE STATUTORY FRAMEWORK -- Subsection 208(b)(1) -- Subsection 208(b)(2) -- Subsection 208(b)(3) -- FDA'S ADMINISTRATION OF CONFLICT-OF-INTEREST RESTRICTIONS -- Screening Potential Committee Members -- Identification of Conflict and Decision to Seek a Waiver -- A RAPIDLY CHANGING SYSTEM -- Notable Controversies -- Psychopharmaceutical Drugs Advisory Committee: Meeting of September20, 1991 -- General and Plastic Surgery Devices Advisory Panel: Meeting of November12-13, 1991 -- Arthritis Drugs Advisory Committee: Meeting of December 6, 1991 -- Blood Products Advisory Committee Meeting: December 12-13, 1991 -- Biologics Response Modifiers Advisory Committee: Meeting of January 16-17, 1992. Dermatologic Drugs Advisory Committee: Meeting of April 10, 1992 -- Circulatory Systems Devices Panel: Meeting of May 11, 1992 -- Analysis of Waiver Processing -- Interpretation -- Glimmers of Progress -- Workload -- Waiver Preparation and Review -- Schedule for Review of Waivers -- Waiver Form -- RECOMMENDATIONS ON FINANCIAL CONFLICT OF INTEREST -- Options Requiring Legislation -- Options Available Within Existing Authority -- INTELLECTUAL BIAS -- Remedies -- Screening -- NOTES -- APPENDIX -- A Suggested Approach to the Codification of Section 208(b)(3) Waiver Criteria -- 7 Committee Operations -- SCHEDULING ADVISORY COMMITTEE MEETINGS -- MEETING PREPARATION -- General Criteria for Setting the Agenda -- Product Evaluation and Guidelines Development at CDER -- Program Management at CDER -- Setting the Agenda -- Content of the Agenda Questions -- Timely Distribution of Materials -- Summaries of Materials Sent to the Committee -- Use of Primary Reviewers -- Communications Issues Before an Advisory Committee Meeting -- FDA Communication to Advisory Committee Members -- Communication Among Advisory Committee Members -- Communication Between Sponsors and Advisory Committee Members -- Agency Communication to Sponsors -- Communication Between the FDA and the Public -- CONDUCTING AN ADVISORY COMMITTEE MEETING -- Roles of the Principal Participants -- Allocation and Control of Agenda Time -- Electronic Coverage of Meetings -- Voting -- Agency Neutrality -- Agency Presentations -- FDA-Committee Interaction -- Seating Arrangements -- Closed Deliberations -- CUSTOM TAILORING OF COMMITTEE MEMBERSHIP -- MEETING FOLLOW-UP -- NOTES -- 8 Organization and Management -- SYSTEM MANAGEMENT -- The Commissioner and His Office -- Center Directors -- Office and Division Directors -- Executive Secretaries -- COMPENSATION -- ORIENTATION AND TRAINING. TYPES OF ADVISORY COMMITTEES -- Policy Advisory Committee -- Other Issues -- AGENCY MANAGEMENT AND ACCOUNTABILITY -- Agency Management -- Agency Accountability -- A CONCLUDING RECOMMENDATION -- NOTES -- Appendix A Resource Implications -- CURRENT SYSTEM COSTS UNDERESTIMATED -- RECOMMENDATIONS THAT WILL HAVE RESOURCE IMPLICATIONS -- Appendix B Glossary. |
| Record Nr. | UNINA-9910827560703321 |
| Washington, D.C., : National Academy Press, 1992 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||