Generic Drug Product Development (Record no. 8367)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02316 a2200337 4500 |
| 001 - CONTROL NUMBER | |
| control field | 1032920602 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250328151424.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 250324042024xx 36 eng |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781032920603 |
| Qualifying information | BC |
| 037 ## - SOURCE OF ACQUISITION | |
| Source of stock number/acquisition | Taylor & Francis |
| Terms of availability | GBP 44.99 |
| Form of issue | BB |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | 01 |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | eng |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | PS |
| Source | thema |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | TDCW |
| Source | thema |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | TBC |
| Source | thema |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | KND |
| Source | thema |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | PS |
| Source | bic |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | TDCW |
| Source | bic |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | TBC |
| Source | bic |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | KNDP |
| Source | bic |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | MED000000 |
| Source | bisac |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | MED071000 |
| Source | bisac |
| 072 7# - SUBJECT CATEGORY CODE | |
| Subject category code | 615.19 |
| Source | bisac |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Leon Shargel |
| 245 10 - TITLE STATEMENT | |
| Title | Generic Drug Product Development |
| Remainder of title | Solid Oral Dosage Forms, Second Edition |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 2 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Name of publisher, distributor, etc. | CRC Press |
| Date of publication, distribution, etc. | 20241014 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 398 p |
| 520 ## - SUMMARY, ETC. | |
| Expansion of summary note | In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Isadore Kanfer |
| Relationship | B01 |
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