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Assessing the impact of a safe and equitable biosimilar policy in the United States : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, May 2, 2007
| Assessing the impact of a safe and equitable biosimilar policy in the United States : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, May 2, 2007 |
| Descrizione fisica | 1 online resource (vi, 184 p.) : ill |
| Soggetto topico |
Biologicals - United States
Pharmaceutical biotechnology - United States Generic drugs - United States |
| Soggetto non controllato |
Biologicals
Pharmaceutical biotechnology Generic drugs Medical Technology & engineering |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States |
| Record Nr. | UNINA-9910694419603321 |
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Biologics and biosimilars [[electronic resource] ] : balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009
| Biologics and biosimilars [[electronic resource] ] : balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2010 |
| Descrizione fisica | 1 online resource (iv, 252 pages) : illustrations |
| Soggetto topico |
Drug development - Government policy - United States
Pharmaceutical biotechnology - Government policy - United States Pharmaceutical biotechnology - United States Biologicals - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Biologics and biosimilars |
| Record Nr. | UNINA-9910698589103321 |
| Washington : , : U.S. G.P.O., , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Emerging safety science [[electronic resource] ] : workshop summary / / Sally Robinson, Robert Pool, and Robert Giffin [rapporteurs] ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
| Emerging safety science [[electronic resource] ] : workshop summary / / Sally Robinson, Robert Pool, and Robert Giffin [rapporteurs] ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2008 |
| Descrizione fisica | xvi, 134 p. : ill. (some col.) |
| Disciplina | 615/.10289 |
| Altri autori (Persone) |
RobinsonSally
PoolRobert GiffinRobert B |
| Soggetto topico |
Drugs - United States - Safety measures
Pharmaceutical biotechnology - United States Drugs - United States - Design |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-281-30023-3
9786611300234 0-309-11013-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910454583503321 |
| Washington, D.C., : National Academies Press, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Emerging safety science [[electronic resource] ] : workshop summary / / Sally Robinson, Robert Pool, and Robert Giffin [rapporteurs] ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
| Emerging safety science [[electronic resource] ] : workshop summary / / Sally Robinson, Robert Pool, and Robert Giffin [rapporteurs] ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2008 |
| Descrizione fisica | xvi, 134 p. : ill. (some col.) |
| Disciplina | 615/.10289 |
| Altri autori (Persone) |
RobinsonSally
PoolRobert GiffinRobert B |
| Soggetto topico |
Drugs - United States - Safety measures
Pharmaceutical biotechnology - United States Drugs - United States - Design |
| ISBN |
0-309-17817-7
1-281-30023-3 9786611300234 0-309-11013-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910782897703321 |
| Washington, D.C., : National Academies Press, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Emerging safety science : workshop summary / / Sally Robinson, Robert Pool, and Robert Giffin [rapporteurs] ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
| Emerging safety science : workshop summary / / Sally Robinson, Robert Pool, and Robert Giffin [rapporteurs] ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2008 |
| Descrizione fisica | xvi, 134 p. : ill. (some col.) |
| Disciplina | 615/.10289 |
| Altri autori (Persone) |
RobinsonSally
PoolRobert GiffinRobert B |
| Soggetto topico |
Drugs - United States - Safety measures
Pharmaceutical biotechnology - United States Drugs - United States - Design |
| ISBN |
0-309-17817-7
1-281-30023-3 9786611300234 0-309-11013-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Front Matter -- Reviewers -- Preface -- Contents -- Tables and Figures -- 1 Introduction -- 2 Investigative Toxicology: The State of the Art -- 3 Screening Technologies I: Human Cell-Based Approaches -- 4 Screening Technologies II: Toxicogenomics -- 5 Screening Technologies III: Metabolomics -- 6 Screening Technologies IV: Pharmacogenetics -- 7 Qualifying Biomarkers -- 8 Pharmacovigilance -- 9 Integration -- 10 The Future of Safety Science -- References -- Appendixes -- Appendix A: Workshop Agenda -- Appendix B: Speaker Biographies. |
| Record Nr. | UNINA-9910809901503321 |
| Washington, D.C., : National Academies Press, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Follow-on biologics [[electronic resource] ] : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007
| Follow-on biologics [[electronic resource] ] : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007 |
| Pubbl/distr/stampa | Washington : , : U.S. G.P.O., , 2008 |
| Descrizione fisica | 1 electronic text (iv, 78 pages) : HTML, digital, PDF file |
| Collana | S. hrg. |
| Soggetto topico |
Pharmaceutical biotechnology - Government policy - United States
Pharmaceutical biotechnology - United States Pharmaceutical technology - Government policy - United States Drug development - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Follow-on biologics |
| Record Nr. | UNINA-9910698695203321 |
| Washington : , : U.S. G.P.O., , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : manufacturing biological intermediates and biological drug substances using spore-forming microorganisms
| Guidance for industry [[electronic resource] ] : manufacturing biological intermediates and biological drug substances using spore-forming microorganisms |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2007] |
| Descrizione fisica | ii, 14 pages : digital, PDF file |
| Soggetto topico |
Intermediates (Chemistry)
Sporeforming bacteria - United States Pharmaceutical biotechnology - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698880003321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals
| Guidance for industry [[electronic resource] ] : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2002] |
| Descrizione fisica | 1 electronic resource (i, 27 pages) |
| Soggetto topico |
Pharmaceutical biotechnology - United States
Medical instruments and apparatus - United States Veterinary biologicals - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910696916803321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
| Guidance for industry [[electronic resource] ] : Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [1998] |
| Descrizione fisica | 1 online resource (i, 30 pages) |
| Soggetto topico |
Pharmaceutical biotechnology - United States
Biological products - Evaluation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699245503321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [1998] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Safe and affordable biotech drugs : the need for a generic pathway : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Tenth Congress, first session, March 26, 2007
| Safe and affordable biotech drugs : the need for a generic pathway : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Tenth Congress, first session, March 26, 2007 |
| Descrizione fisica | 1 online resource (iv, 274 p.) : ill |
| Soggetto topico |
Biologicals - United States
Pharmaceutical biotechnology - United States Generic drugs - United States |
| Soggetto non controllato |
Biologicals
Pharmaceutical biotechnology Generic drugs Medical Technology & engineering |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Safe and affordable biotech drugs |
| Record Nr. | UNINA-9910694411303321 |
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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