Drug Interaction Studies M12: step 1, Nov 2019 ( PDF 86KiB).
Addendum: Statistical Principles for Clinical Trials E9(R1): step 2, Jun 2017 ( PDF 310KiB), Concept Paper Oct 2014 ( PDF 173KiB).Statistical Principles for Clinical Trials E9: Feb 1998 ( PDF 284KiB).Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A: step 4, Oct 1994 ( PDF 145KiB).Ethnic Factors in the Acceptability of Foreign Clinical Data E5(R1): step 4, Mar 1998 ( PDF 187KiB), Q&A: Jun 2006 ( PDF 66KiB).General Considerations for Clinical Trials E8: Jul 1997 ( PDF 182KiB).General Considerations for Clinical Trials E8(R1): step 2 May 2019 ( PDF 295KiB).Good Clinical Practice E6(R1): step 4, Jun 1996 ( PDF 380KiB including IB template).Structure and Content of Clinical Study Reports E3: Nov 1995 ( PDF 471KiB), Q&As (R1): Jul 2012 ( PDF 158KiB).
Ich guidance update#
Development Safety Update Report E2F: step 4, Aug 2010 ( PDF 334KiB).All documents are in step 5 (implementation state) even if step 4 is mentioned in some of the documents.Pharmaceutical Development Q8(R2): step 4, Aug 2009 ( PDF 764KiB).Biotechnological/Biological Products Q6B: Mar 1999 ( PDF 204KiB).New Drug Substances and New Drug Products: Chemical Substances Q6A: Oct 1999 ( PDF 211KiB, Decision Trees PDF 46KiB).Specifications: Test Procedures and Acceptance Criteria.Analytical Procedure Development and Revision of Q2(R1): Concept Paper Nov 2018 ( PDF 92KiB).Validation of Analytical Procedures: Text and Methodology Q2(R1): step 4, Nov 2005 ( PDF 180KiB).International Council for Harmonisation Guidelines.While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or ethics committees before starting research activities. In addition, because new standards are issued on a continuing basis, this Collection should not be considered an exhaustive source of all current applicable laws, regulations, and guidelines in the field. If you encounter broken links or are acquainted with any missing / updated documents please notify the webmaster.Īlthough this Collection contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. Note also updates/revisions UD and additions new within the last six months. Documents published within the last two years are marked. While obsolete, previous versions are helpful in dealing with deficiency letters issued for “old” studies. Documents superseded by newer versions are striken through. Language codes are given according to ISO 639-1 ( i.e., English en, French fr, German de, Spanish es, Danish da, Portuguese pt, Japanese ja, Chinese zh, Russian ru, Arabic ar, …)Īlthough links to documents are considered current with, you should always consult websites of the respective regulatory body for any updated versions. Linked guidances/guidelines are in English, unless stated otherwise. Main topic of this collection is Bioavailability / ( in-vivo-) Bioequivalence, although GCP/ GLP, dissolution/ BCS, pharmacokinetics, bioanalytics and -statistics are covered to some minor extent as well. de Salud ANMAT INVIMA SFDA JFDA MoH EDA ACCSQ BPFK FDA HSA NA-DFC KFDA CDE CFDA MHSD EEC Swissmedic TİTCK MoH EAC MCAZ NDA OECD PIC/S EDQM Introduction Guidelines & Guidance Documents ICH WHO EMA FDA HPFB PMDA SAHPRA TGA Medsafe CDSCO DGDA PAHO ANVISA Secr.
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