| 000 | 02478nam a22002297a 4500 | ||
|---|---|---|---|
| 005 | 20241128203514.0 | ||
| 008 | 241128b |||||||| |||| 00| 0 eng d | ||
| 020 | _a9780128222119 | ||
| 082 |
_a615.19 _bALI |
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| 245 | _aRegulatory affairs in the pharmaceutical industry | ||
| 260 |
_bAcademic Press _aLondon _c2022 |
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| 300 | _axvi, 269 p. | ||
| 365 |
_aUSD _b200.00 |
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| 500 | _aTable of content: 1. Documentation in Pharmaceutical industry 2. Generic drugs product development 3. CFR (CODE OF FEDERAL REGULATION) 4. ANDA regulatory approval process 5. NDA approval process 6. Post marketing surveillance 7. US registration for foreign drugs 8. Regulation for combination products and medical devices 9. CTD and ECTD formats 10. Regulatory Guidelines of ICH-Q, S E, M 11. Regulatory requirements of EU, MHRA, TGA and ROW countries 12. Global submission of IND, NDA, ANDA 13. Investigation of medicinal products dossier 14. Regulatory Affairs in Clinical trials 15. Pharmacovigilance safety monitoring [https://shop.elsevier.com/books/regulatory-affairs-in-the-pharmaceutical-industry/ali/978-0-12-822211-9] | ||
| 520 | _aRegulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. (https://shop.elsevier.com/books/regulatory-affairs-in-the-pharmaceutical-industry/ali/978-0-12-822211-9) | ||
| 650 |
_aPharmaceutical industry _98814 |
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| 650 |
_aPharmaceutical policy _919118 |
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| 650 |
_aDrugs law--legislation _919119 |
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| 700 |
_aAli, Javed [Editor] _919120 |
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| 700 |
_aBaboota, Sanjula {Editor] _919121 |
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| 942 |
_cBK _2ddc |
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| 999 |
_c7378 _d7378 |
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