Global Approach in Safety Testing (Record no. 276448)
[ view plain ]
| 000 -LEADER | |
|---|---|
| fixed length control field | 05203nam a22005055i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-1-4614-5950-7 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20160615110138.0 |
| 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 | 130217s2013 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781461459507 |
| -- | 978-1-4614-5950-7 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-1-4614-5950-7 |
| Source of number or code | doi |
| 049 ## - LOCAL HOLDINGS (OCLC) | |
| Holding library | Alfaisal Main Library |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS380 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS190-210 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | TDCW |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED072000 |
| Source | bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.19 |
| Edition number | 23 |
| 245 10 - TITLE STATEMENT | |
| Title | Global Approach in Safety Testing |
| Medium | [electronic resource] : |
| Remainder of title | ICH Guidelines Explained / |
| Statement of responsibility, etc | edited by Jan Willem van der Laan, Joseph J. DeGeorge. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE STATEMENTS | |
| Place of production, publication, distribution, manufacture | New York, NY : |
| Name of producer, publisher, distributor, manufacturer | Springer New York : |
| -- | Imprint: Springer, |
| Date of production, publication, distribution, manufacture | 2013. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | XII, 315 p. 16 illus., 13 illus. in color. |
| Other physical details | online resource. |
| 336 ## - CONTENT TYPE | |
| Content Type Term | text |
| Content Type Code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media Type Term | computer |
| Media Type Code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier Type Term | online resource |
| Carrier Type Code | cr |
| Source | rdacarrier |
| 347 ## - | |
| -- | text file |
| -- | |
| -- | rda |
| 490 1# - SERIES STATEMENT | |
| Series statement | AAPS Advances in the Pharmaceutical Sciences Series, |
| International Standard Serial Number | 2210-7371 ; |
| Volume number/sequential designation | 5 |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | The International Conference on Harmonisation. History of Safety Guidelines -- EU Perspective on ICH -- The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities Advancing Harmonization for Better Public Health -- A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process -- Towards more Scientific Relevance in Carcinogenicity Testing -- The Evolution, Scientific Reasoning and Use of ICH S2 Guidelines for Genotoxicity Testing of Pharmaceuticals -- Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies , Where are we now; an S3A/S3B update (1995-2011) -- Duration of Acute and Chronic Toxicity Testing in Animals (ICH S4A and S4B) -- Why and how did Reproduction Toxicity Testing make its early entry into and Rapid Success in ICH? -- ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals -- Safety Pharmacology: Guidelines S7A and S7B -- ICH S8: History and Perspectives -- ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals a Perspective from Regulators on the Development of the Guideline -- Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals ICH M3 and M3(R2). |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc | The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. In Japan, the members are the Ministry of Health, Labour and Welfare (MHLW), and the Japan Pharmaceutical Manufacturers Association (JPMA). In Europe, the members are the EU (Representatives of the European Commission and the European Medicines Agency [EMA]), and the European Federation of Pharmaceutical Industries and Associations (EFPIA). In the United States, the members are the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) is the secretariat of the ICH. Additional members include Observers from WHO, European Free Trade Association (EFTA), and Canada. The Observers represent non-ICH countries and regions. This volume considers one of ICH’s major categories, Safety, covering topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but in most cases there is a lack of awareness of the many issues that were addressed during the development of the consensus guidances. Further, just as it is important to understand what the guidances state, it is also important to understand the thoughts, debates, and intent of the experts involved, which are not included in the guidance documents. Why has the guideline been written as it is written, why are some topics ignored, and why have some initial guidance proposals have been deleted. These and other related questions and answers are the contents of this book, written by experts who were directly involved in writing the ICH guidances that drive drug development today. |
| 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 | Pharmaceutical technology. |
| 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 | Pharmaceutical Sciences/Technology. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Biomedicine general. |
| 655 #7 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| Source of term | local |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | van der Laan, Jan Willem. |
| Relator term | editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | DeGeorge, Joseph J. |
| Relator term | editor. |
| 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 | 9781461459491 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | AAPS Advances in the Pharmaceutical Sciences Series, |
| -- | 2210-7371 ; |
| Volume number/sequential designation | 5 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://ezproxy.alfaisal.edu/login?url=http://dx.doi.org/10.1007/978-1-4614-5950-7">http://ezproxy.alfaisal.edu/login?url=http://dx.doi.org/10.1007/978-1-4614-5950-7</a> |
| 912 ## - | |
| -- | ZDB-2-SBL |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Library of Congress Classification |
| Koha item type | eBooks |
No items available.