Drug biotechnology regulation: scientific basis and practices
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York u.a.
Dekker
1991
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XXIII, 563 S. |
| ISBN: | 0824784200 |
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| 245 | 1 | 0 | |a Drug biotechnology regulation |b scientific basis and practices |c ed. by Yuan-yuan H. Chiu ... |
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Datensatz im Suchindex
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|---|---|
| adam_text | DRUG BIOTECHNOLOGY REGULATION SCIENTIFIC BASIS AND PRACTICES EDITED BY
YUAN-YUAN H. CHIU JOHN L. GUERIGUIAN FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MARYLAND MARCEL DEKKER, INC. NEW YORK * BASEL * HONG KONG
CONTENTS SERIES INTRODUCTION III PREFACE V CONTRIBUTORS XI MEDICAL
BIOTECHNOLOGY: A BRIEF HISTORICAL SURVEY XV MICHEL BERNON AND JACQUES
BODELLE I. EXPERIENCES OF THE PAST 1. BIOLOGICAL PRODUCTION SYSTEMS I.
STABILITY OF RECOMBINANT PLASMIDS FOR PRODUCTION OF HETEROLOGOUS
PROTEINS IN ESCHERICHIA COLI 3 CHARLES L. HERSHBERGER AND PAUL R.
ROSTECK, JR. * II. RECOMBINANT YEAST AS A PRODUCTION SYSTEM IN
BIOTECHNOLOGY 16 BERNARDITA MENDEZ AND PABLO VALENZUELA X III. THE
PREPARATION AND VALIDATION OF STOCK CULTURES OF MAMMALIAN CELLS 54
THOMAS J. FACKLAM AND SCOTT GEYER P IV. GENETIC AND MOLECULAR STUDIES TO
CERTIFY SEED POOLS AND PRODUCTION FERMENTATIONS OF INDUSTRIAL
ESCHERICHIA COLI STRAINS 86 CHARLES L. HERSHBERGER AND PAUL R. ROSTECK,
JR. 2. PRODUCTION FACILITIES I. FERMENTERS FOR PROKARYOTIC CELLS 103
WILLIAM L. MUTH II. BIOREACTOR AND PROCESS DESIGN FOR LARGE-SCALE
MAMMALIAN CELL CULTURE MANUFACTURING 112 KIM L. NELSON AND SCOTT GEYER
VII VIII CONTENTS III. AUTOMATIC CONTROL SYSTEMS 144 JOSEPH S. ALFORD,
JR. 3. DRUG MANUFACTURE I. FERMENTATION PROCESSES FOR PROKARYOTIC CELLS
155 WILLIAM L. MUTH II. YEAST FERMENTATION PROCESSES FOR INSULIN
PRODUCTION 166 IVAN V. DIERS, EIGIL RASMUSSEN, PER HENRIK LARSEN, AND
INGE-LISE KJAERSIG III. INDUSTRIAL SCALE MAMMALIAN CELL CULTURE 177
ROBERT ARATHOON AND T. G. HUGHES IV. POSTBIOSYNTHESIS MODIFICATION:
HUMAN GROWTH HORMONE AND INSULIN PRECURSORS 206 THORKILD CHRISTENSEN,
HENRIK DALB0GE, AND LEO SNEL V. PRODUCTION-SCALE PURIFICATION PROCESSES
221 WALTER F. PROUTY 4. CHARACTERIZATION OF PROTEINS FROM RECOMBINANT
DNA MANUFACTURE 263 ROBERT L. GARNICK, MICHAEL J. ROSS, AND ROBERT A.
BAFFI 5. FOOD AND DRUG ADMINISTRATION INSPECTION AND LICENSING OF
MANUFACTURING FACILITIES 315 HENRY L. AVALLONE, MICHAEL G. BEATRICE, AND
THADDEUS T. SZE 6. SAFETY AND EFFICACY EVALUATION OF RECOMBINANT DNA
PRODUCTS I. SCIENTIFIC AND REGULATORY CONSIDERATIONS IN THE
DEVELOPMENT OF HUMAN GROWTH FACTORS 341 G. ALEXANDER FLEMING, ALEXANDER
W. JORDAN, AND YUAN-YUAN H. CHIU II. RECOMBINANT YEAST-DERIVED HEPATITIS
B VACCINE: THE PROTOTYPE FOR BIOTECHNOLOGICALLY DERIVED OLD VACCINES 355
RONALD W. ELLIS 7. INDUSTRY S VIEW ON GOVERNMENT REGULATORY ACTIVITIES
I. INDUSTRY S EXPERIENCE WITH WORLDWIDE REGULATION OF BIOTECHNOLOGY
PRODUCTS 371 ALAN DINNER AND JOHN M. FOSE II. CULTURING A BIOTECH
COMPANY IN A REGULATORY MEDIUM 382 ROBERT A. SWANSON CONTENTS IX II.
FUTURE PROSPECTS 8. POTENTIALLY USEFUL BIOLOGICAL PRODUCTION SYSTEMS I.
FUNGI AS BIOPROCESSING SYSTEMS FOR THE PRODUCTION OF PHARMACEUTICALLY
IMPORTANT PROTEINS 391 DAVID I. GWYNNE AND NIGEL J. SMART II.
BACULOVIRUS EXPRESSION SYSTEMS AND INSECT CELLS 402 JENNIFER A. JACKSON
9. SECOND-GENERATION PRODUCTS I. SECOND-GENERATION PRODUCTS: ANTIBIOTICS
415 JEFFREY T. FAYERMAN II. NOVEL APPROACHES FOR THE PRODUCTION OF
BIOTECHNOLOGICALLY DERIVED VACCINES OF THE FUTURE 425 RONALD W. ELLIS
III. ADVANCES TOWARD SOMATIC CELL GENE THERAPY 439 DVORIT SAMID, W.
FRENCH ANDERSON, AND ROBERT C. MOEN 10. INTERNATIONAL HARMONIZATION
AMONG WORLDWIDE REGULATORY AGENCIES I. HARMONIZATION OF BIOTECHNOLOGICAL
REGULATIONS IN THE EUROPEAN COMMUNITY 455 FERNAND SAUER II. THE JAPANESE
PERSPECTIVE REGARDING REGULATORY CONCERNS FOR BIOTECHNOLOGY DRUGS AND
THEIR SCIENTIFIC BASIS 468 TAKAO HAYAKAWA III. REGULATORY EVALUATION OF
BIOTECHNOLOGY DRUGS: CURRENT TRENDS IN THE UNITED STATES 499 SOLOMON
SOBEL 11. A SCENARIO FOR THE FUTURE: BIOTECHNOLOGY AND PHARMACOGENESIS
513 JOHN L. GUERIGUIAN, YUAN-YUAN H. CHIU, DOMINIC P. GANGI, AND
GEOFFROY D AUMALE APPENDIX A COMPILATION OF GOVERNMENT REGULATION OF ,
BIOTECHNOLOGY 525 JOSEPH PAUL HILE, BARBARA H. KEECH, C. K. GUND, AND
WENDY M. CONNOLLY INDEX 545
|
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| dewey-full | 615/.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
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| dewey-search | 615/.19 |
| dewey-sort | 3615 219 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
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| isbn | 0824784200 |
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| spelling | Drug biotechnology regulation scientific basis and practices ed. by Yuan-yuan H. Chiu ... New York u.a. Dekker 1991 XXIII, 563 S. txt rdacontent n rdamedia nc rdacarrier Biopharmacie Biopharmacie - Coopération internationale Biopharmacie - Droit Biotechnologie Biotechnologie - Coopération internationale Génie génétique - Droit Recht Biological Products Biotechnology Drug Industry International Cooperation Legislation, Drug Pharmaceutical biotechnology Pharmaceutical biotechnology Law and legislation Technology, Pharmaceutical Biotechnologie (DE-588)4069491-4 gnd rswk-swf Recht (DE-588)4048737-4 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Pharmazeutische Technologie (DE-588)4045699-7 s Biotechnologie (DE-588)4069491-4 s Recht (DE-588)4048737-4 s DE-604 Chiu, Yuan-yuan H. Sonstige oth GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=002765311&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Drug biotechnology regulation scientific basis and practices Biopharmacie Biopharmacie - Coopération internationale Biopharmacie - Droit Biotechnologie Biotechnologie - Coopération internationale Génie génétique - Droit Recht Biological Products Biotechnology Drug Industry International Cooperation Legislation, Drug Pharmaceutical biotechnology Pharmaceutical biotechnology Law and legislation Technology, Pharmaceutical Biotechnologie (DE-588)4069491-4 gnd Recht (DE-588)4048737-4 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| subject_GND | (DE-588)4069491-4 (DE-588)4048737-4 (DE-588)4045699-7 (DE-588)4143413-4 |
| title | Drug biotechnology regulation scientific basis and practices |
| title_auth | Drug biotechnology regulation scientific basis and practices |
| title_exact_search | Drug biotechnology regulation scientific basis and practices |
| title_full | Drug biotechnology regulation scientific basis and practices ed. by Yuan-yuan H. Chiu ... |
| title_fullStr | Drug biotechnology regulation scientific basis and practices ed. by Yuan-yuan H. Chiu ... |
| title_full_unstemmed | Drug biotechnology regulation scientific basis and practices ed. by Yuan-yuan H. Chiu ... |
| title_short | Drug biotechnology regulation |
| title_sort | drug biotechnology regulation scientific basis and practices |
| title_sub | scientific basis and practices |
| topic | Biopharmacie Biopharmacie - Coopération internationale Biopharmacie - Droit Biotechnologie Biotechnologie - Coopération internationale Génie génétique - Droit Recht Biological Products Biotechnology Drug Industry International Cooperation Legislation, Drug Pharmaceutical biotechnology Pharmaceutical biotechnology Law and legislation Technology, Pharmaceutical Biotechnologie (DE-588)4069491-4 gnd Recht (DE-588)4048737-4 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd |
| topic_facet | Biopharmacie Biopharmacie - Coopération internationale Biopharmacie - Droit Biotechnologie Biotechnologie - Coopération internationale Génie génétique - Droit Recht Biological Products Biotechnology Drug Industry International Cooperation Legislation, Drug Pharmaceutical biotechnology Pharmaceutical biotechnology Law and legislation Technology, Pharmaceutical Pharmazeutische Technologie Aufsatzsammlung |
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