BEBAC   Ing. Helmut Schütz

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Guidelines & Guidance Documents

Introduction

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.

Linked guidances/guidelines are in English, unless stated otherwise. 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, Arabic ar,…)

Although links to documents are considered current with 30 May 2016, you should always consult websites of the respective regulatory body for any updated versions. Documents superseded by newer versions are striken through. While obsolete, previous versions are helpful in dealing with deficiency letters issued for “old” studies. Documents published within the last two years are marked. UpdatesUD and additionsnew within the last six months.
If you encounter broken links or are acquainted with any missing / updated documents please notify the webmaster.

Disclaimer

Although 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. 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. 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.

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