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BEBAC  Ing. Helmut Schütz

News-Index

To the right you may find pages in chrono­logical order.
Pages below are ordered by topic.

General Guidances

Bioequivalence

  1. 2006-01-17 DKMA: 100% included in Con­fidence Interval; 90-111% for NTI-DrugsUpdate 2010-02-08
  2. 2006-05-19 WHO: Fortieth Report
  3. 2006-05-31 HPFB: BE Requirements: Critical Dose Drugs
  4. 2006-07-27 EMEA: Questions & Answers Document to NfG on BA/BE
  5. 2006-11-24 NIHS: Revision of 4 NfGs on BA/BE and corresponding Questions & Answers Documents; new Guideline for Topicals
  6. 2007-05-24 EMEA: Recommendation on the need for revision of (CHMP) <NfG on the investigation of BA and BE>
  7. 2008-07-24 EMEA: Guideline on the Investigation of Bioequivalence, Revision of 2001 NfG (Draft)
  8. 2010-01-25 HPFB: Draft Guidance Documents: Conduct and Analysis of Comparative Bioavailability Studies, Comparative Bioavailability Standards: Formulations used for Systemic Effects
  9. 2010-01-29 EMA: Guideline on the Investigation of Bioequivalence (Final)

BCS

  1. 2006-05-19 WHO: Fortieth Report
  2. 2007-05-24 EMEA: Concept Paper on BCS-based Biowaiver
  3. 2008-04-25 WHO: Prequalification of Medicines Programme – Implementation of BCS

Miscellaneous

  1. 2006-05-23 HPFB: Records Related to Clinical Trials
  2. 2007-10-18 EMEA: Reflection Paper on Advice to Applicants/Sponsors/CROs of BE StudiesUpdate 2008-09-19
  3. 2009-01-22 EMEA: Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on PharmacokineticsUpdate 2010-07-22
  4. 2009-06-12 FDA: Website Redesign
  5. 2009-08-03 EMEA/FDA: Joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities
  6. 2009-11-19 EMA: Draft Guideline on Validation of Bioanalytical Methods

Highly Variable Drugs

  1. 2006-04-27 EMEA: Concept PaperUpdate 2008-07-03
  2. 2006-10-06 FDA: ACPS MeetingUpdate 2009-01-19
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