shortlived

BEBAC   Ing. Helmut Schütz

News-Index

To the right pages are listed in chrono­logical order. Pages below are ordered by topic. Obsolete documents are striken through.

General Guidances

Bioequivalence

  1. 2006-01-17 DKMA: 100% included in Con­fidence Inter­val; 90-111% for NTI-Drugs Update 2012-02-07
  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 four Guidelines on 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  8. 2010-01-25 HPFB: Draft Guidance Documents: Conduct and Analysis of Comparative BA Studies, Comparative BA Standards: Formulations used for Systemic Effects
  9. 2010-01-29 EMA: Guideline on the Investigation of BE (Final)
  10. 2011-11-17 EMA: Appendix IV of Guideline on the Investigation of BE
  11. 2012-02-29 NIHS: Revision of four Guidelines on BE and corresponding Questions & Answers Documents; new Q&As on Ethical Combination Drug Products
  12. 2012-05-22 HPFB: Conduct and Analysis of Comparative BA Studies, Comparative BA Standards: Formulations used for Systemic Effects
  13. 2012-08-22 FDA: Draft Guidance: Self-Identification of Generic Drug Facilities, Sites, and Organizations
  14. 2013-03-15 EMA: Draft Guideline on the PK and clinical evaluation of MR dosage forms
  15. 2013-11-15 EMA: Draft product-specific guidance on the demonstration of BE Update 2016-12-22
  16. 2013-12-04 FDA: Draft Guidance: BE Studies with PK Endpoints for Drugs Submitted Under an ANDA
  17. 2014-03-18 FDA: Draft Guidance: BA and BE Studies Submitted in NDAs or INDs — General Considerations

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
  4. 2012-08-21 HPFB: Draft Guidance Document – BCS Based Biowaiver

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 Studies Update 2008-09-19
  3. 2009-01-22 EMEA: Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on PK Update 2015-11-19
  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 Update 2011-07-11
  7. 2012-02-09 FDA: Draft Biosimilar Guidances
  8. 2012-09-14 EMA: Draft guidelines on oral modified release products and transdermal patches (Section I: quality)
  9. 2013-09-13 FDA: Draft Guidance on Bioanalytical Method Validation
  10. 2013-12-04 FDA: Draft Guidance: Size, Shape, and Other Physical Attributes of Gene­ric Tablets and Capsules
  11. 2013-12-18 EMA/FDA: Joint initiative to share information on inspections of BE studies
  12. 2014-05-14 FDA: Draft Guidance on Clinical Pharmacology Data to Support a Demon­stration of Biosimilarity to a Reference Product
  13. 2014-10-23 EMA: Guideline on similar biological medicinal products

Highly Variable Drugs

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