Harmonisation

Results: 1188



#Item
731Knowledge representation / Technical communication / Interoperability / Telecommunications / Dublin Core / Indecs Content Model / Application profile / Semantic interoperability / Handle System / Information / Data / Metadata

Proc. Int. Conf. on Dublin Core and Metadata for e-Communities 2002: [removed] © Firenze University Press Visualising Interoperability: ARH, Aggregation, Rationalisation and Harmonisation Michael Currie, Meigan Geileskey,

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Source URL: www.bncf.net

Language: English - Date: 2013-03-27 08:08:59
732Clinical research / Pharmacology / Pharmaceutical industry / Drug safety / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Biotechnology / Regulatory requirement / Food and Drug Administration / Japan Pharmaceutical Manufacturers Association / Pharmaceutical sciences / Pharmaceuticals policy / Research

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Dated a

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:08:19
733Science / Micronucleus test / Comet assay / Mutagen / In vitro / Micronucleus / In vivo / Assay / Biology / Chemistry / Mutation

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceutica

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:08:09
734Immunotoxins / Mutagens / Occupational safety and health / Cumene / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Propylbenzene / Environmental Working Group / Solvent / N-Propyl bromide / Chemistry / Soil contamination / Benzene

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper Q3C(R5): Impurities : Guideline for Residual Solvents (Revision of the ICH Q3C(R4)

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:08:41
735Medical informatics / Drug safety / Electronic Common Technical Document / Medicine / Pharmaceuticals policy / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Health / Clinical research / Research / Clinical Data Management

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper Addressing CTD-Q-Related Questions/Change Requests Raised by eCTD

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:07:56
736Health / Drug discovery / Pharmaceutical sciences / Pharmacology / Medical statistics / Clinical trial / Drug development / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Phases of clinical research / Research / Clinical research / Pharmaceutical industry

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper M3(R2): Revision of ICH M3(R1): Maintenance of the ICH Guideline on Non-Clinical S

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:13:12
737Molecular biology / Medical research / Clinical research / Bioethics / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Gene therapy / Viral vector / Virus / Oncolytic virus / Biology / Medicine / Gene delivery

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and Transmission dated 26

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:12:06
738Toxicology / Maximum tolerated dose / Dose

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper S1C(R2): Revision of S1C(R1) Dose Selection in Carcinogenicity Studies of Pharmace

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:08:24
739International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Impurity / Solvent / Health / Chemistry / Pharmacopoeias / Medicine

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper Q3C: Impurities: Guideline for Residual Solvents Dated and endorsed by the Steerin

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:08:42
740Drug safety / Pharmaceutical sciences / Research / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Regulatory requirement / Health / Impurity / Pharmaceutical drug / Active ingredient / Pharmaceuticals policy / Pharmacology / Clinical research

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper Q3B: Guideline on Impurities in Drug Products Dated and endorsed by the Steering C

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:11:37
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