Safety Evaluation of Pharmaceuticals and Medical Devices (Record no. 105769)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 03027nam a22004575i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-1-4419-7449-5 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20140220083723.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 101029s2011 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781441974495 |
| -- | 978-1-4419-7449-5 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-1-4419-7449-5 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RM1-950 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MMG |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED071000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615 |
| Edition number | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Gad, Shayne C. |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | Safety Evaluation of Pharmaceuticals and Medical Devices |
| Medium | [electronic resource] : |
| Remainder of title | International Regulatory Guidelines / |
| Statement of responsibility, etc | by Shayne C. Gad. |
| 264 #1 - | |
| -- | Boston, MA : |
| -- | Springer US, |
| -- | 2011. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | XII, 128p. 2 illus. in color. |
| Other physical details | online resource. |
| 336 ## - | |
| -- | text |
| -- | txt |
| -- | rdacontent |
| 337 ## - | |
| -- | computer |
| -- | c |
| -- | rdamedia |
| 338 ## - | |
| -- | online resource |
| -- | cr |
| -- | rdacarrier |
| 347 ## - | |
| -- | text file |
| -- | |
| -- | rda |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Preface -- Introduction to Safety Assessment in Drug and Medical Device Development -- Drugs: The General Case -- Ind Enabling Toxicology Programs -- Nonclinical Safety Evaluation Studies Conducted To Support Continued Clinical Development -- Supporting Marketing Applications -- Special Therapeutic Category And Route Of Administration Cases -- Device Safety Evaluation -- Appendix A -- INDEX. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc | Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing approval. This intent is purposely extended to cover the closely related product types of vaccines, biotechnology products, gene therapy, cell therapy, and combination products into a single, concise guide for the process in all the major world market countries. The approach of this volume is to first address the broadest scope “general case” for the regulatory nonclinical safety evaluation by ICH and ISO adhering countries, then to branch out to cover the differences in requirements associated with specific therapeutic areas (such as oncology), major routes of administration (with oral being the general case, other routes starting with parentheral, dermal and inhalation are addressed). Large molecules biotechnology products are then considered, followed by special courses of product marketing approval, and finally the remaining national differences. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medicine. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Toxicology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical technology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacy. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Biomedicine. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacology/Toxicology. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmaceutical Sciences/Technology. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Pharmacy. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY | |
| Title | Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Display text | Printed edition: |
| International Standard Book Number | 9781441974488 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | http://dx.doi.org/10.1007/978-1-4419-7449-5 |
| 912 ## - | |
| -- | ZDB-2-SBL |
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