MARC details
| 000 -LEADER |
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| fixed length control field |
02478nam a22002297a 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20241128203514.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
241128b |||||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9780128222119 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
615.19 |
| Item number |
ALI |
| 245 ## - TITLE STATEMENT |
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| Title |
Regulatory affairs in the pharmaceutical industry |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
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| Name of publisher, distributor, etc. |
Academic Press |
| Place of publication, distribution, etc. |
London |
| Date of publication, distribution, etc. |
2022 |
| 300 ## - PHYSICAL DESCRIPTION |
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| Extent |
xvi, 269 p. |
| 365 ## - TRADE PRICE |
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| Price type code |
USD |
| Price amount |
200.00 |
| 500 ## - GENERAL NOTE |
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| General note |
Table of content:<br/>1. Documentation in Pharmaceutical industry<br/><br/>2. Generic drugs product development<br/><br/>3. CFR (CODE OF FEDERAL REGULATION)<br/><br/>4. ANDA regulatory approval process<br/><br/>5. NDA approval process<br/><br/>6. Post marketing surveillance<br/><br/>7. US registration for foreign drugs<br/><br/>8. Regulation for combination products and medical devices<br/><br/>9. CTD and ECTD formats<br/><br/>10. Regulatory Guidelines of ICH-Q, S E, M<br/><br/>11. Regulatory requirements of EU, MHRA, TGA and ROW countries<br/><br/>12. Global submission of IND, NDA, ANDA<br/><br/>13. Investigation of medicinal products dossier<br/><br/>14. Regulatory Affairs in Clinical trials<br/><br/>15. Pharmacovigilance safety monitoring<br/>[https://shop.elsevier.com/books/regulatory-affairs-in-the-pharmaceutical-industry/ali/978-0-12-822211-9] |
| 520 ## - SUMMARY, ETC. |
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| Summary, etc. |
Regulatory 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).<br/><br/>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.<br/><br/>(https://shop.elsevier.com/books/regulatory-affairs-in-the-pharmaceutical-industry/ali/978-0-12-822211-9) |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name as entry element |
Pharmaceutical industry |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name as entry element |
Pharmaceutical policy |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs law--legislation |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Personal name |
Ali, Javed [Editor] |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Personal name |
Baboota, Sanjula {Editor] |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Book |
| Source of classification or shelving scheme |
Dewey Decimal Classification |