| 000 | 04044cam a22004934i 4500 | ||
|---|---|---|---|
| 999 |
_c10410 _d10410 |
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| 001 | 15634211 | ||
| 005 | 20200915134542.0 | ||
| 008 | 090219s2009 nyua b 001 0 eng | ||
| 010 | _a 2009007532 | ||
| 016 | 7 |
_a101496762 _2DNLM |
|
| 020 | _a9781420088496 (hardcover : alk. paper) | ||
| 020 | _a1420088491 (hardcover : alk. paper) | ||
| 035 | _a(OCoLC)ocn311059894 | ||
| 040 |
_aDNLM/DLC _cDLC _dBTCTA _dBAKER _dYDXCP _dNLM _dC#P _dBWX _dDLC _erda |
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| 042 | _apcc | ||
| 043 | _an-us--- | ||
| 050 | 0 | 0 |
_aRS189 _b.N476 2009 |
| 082 | 0 | 0 |
_a615.1 _222 _bN |
| 245 | 0 | 0 |
_aNew drug approval process / _cedited by Richard A. Guarino. |
| 250 | _afifth edition. | ||
| 264 | 1 |
_aNew York : _bInforma Healthcare, _c[2010] |
|
| 300 |
_axviii, 529 pages : _billustrations ; _c24 cm |
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| 336 |
_2rdacontent _atext |
||
| 337 |
_2rdamedia _aunmediated |
||
| 338 |
_2rdacarrier _avolume |
||
| 490 | 1 |
_aDrugs and the pharmaceutical sciences ; _vv. 190 |
|
| 500 | _apharmacy bookfair2016 | ||
| 504 | _aIncludes bibliographical references and index. | ||
| 505 | 0 | _a Front Cover -- Preface -- Contents -- PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT -- 1. Drug Development Teams -- 2. FDA Approvable Indications and Other Considerations -- 3. Data Presentation for Global Submissions: Text and Tabular Exposition-CTD Format -- 4. Technology Change-Enabling Clinical Research and Drug Development Processes -- 5. Working with a Contract Research Organization (CRO) -- 6 Industry and FDA Liaison -- PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL -- 7. Nonclinical Drug Development: Pharmacology, DrugMetabolism, and Toxicology -- 8. The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator's Brochure (IB) -- 9. New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats -- 10. Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs) -- 11. The CTD and eCTD for the Registration of Pharmaceuticals for Human Use -- 12. The Biologic License Application -- 13. Chemistry, Manufacturing, and Control (ICH Quality Guidelines) -- 14. New Medical Device Approval Process in the United States -- 15. Orphan Drugs -- PART III DEVELOPING CLINICAL RESEARCH TRIALS -- 16. Clinical Research Protocols -- 17. Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials -- 18. HIPAA: A New Requirement to the Clinical Study Pr -- 19. Adverse Events and Reactions: Etiology, Drug Interactions, Collection, andReporting -- 20. Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions -- PART IV GLOBAL REGULATIONS FOR GOOD CLINICAL PRACTICES (GCP) -- 21. CFR/ICH/EU GCP Obligations of Investigators, Sponsors, andMonitors -- 22. Quality Assurance. 23. Managing and Monitoring Clinical Trials -- 24. European CT Directive: Implementation and Update -- PART V SPECIFIC AREAS OF NEW PRODUCT SUBMISSIONS -- 25. Combination Products -- 26. The Current State of GXP in China -- Acronyms and Initialisms -- Index. | |
| 650 | 0 |
_aDrug approval _zUnited States. |
|
| 650 | 0 |
_aDrugs _xTesting _xStandards. |
|
| 650 | 0 |
_aDrugs _xTesting _xGovernment policy _zUnited States. |
|
| 650 | 0 |
_aNew products _xGovernment policy _zUnited States. |
|
| 650 | 1 | 2 |
_aDrug Evaluation _xstandards _zUnited States. _98637 |
| 650 | 2 | 2 |
_aClinical Trials as Topic _xstandards _zUnited States. |
| 650 | 2 | 2 |
_aDrug Approval _zUnited States. |
| 700 | 1 |
_aGuarino, Richard A., _d1935-, _eeditor. |
|
| 830 | 0 |
_aDrugs and the pharmaceutical sciences ; _vv. 190. |
|
| 856 |
_3Abstract _uhttp://repository.fue.edu.eg/xmlui/handle/123456789/1816 |
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| 906 |
_a7 _bcbc _corignew _d1 _eecip _f20 _gy-gencatlg |
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| 942 |
_2ddc _cBK |
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