Works matching IS 05123054 AND DT 2017

Results: 59

Evaluation of certain food additives.

Published in:: 2017
Publication type:: Book

The Selection and Use of Essential Medicines.

Published in:: WHO Technical Report Series, 2017, n. 1006, p. vii
Publication type:: Article

WHO Expert Committee on Drug Dependence.

Published in:: WHO Technical Report Series, 2017, n. 1005, p. i
Publication type:: Article

Annex 11: Biological substances: WHO International Standards, Reference Reagents and Reference Panels.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 589
Publication type:: Article

Annex 10: Human challenge trials for vaccine development: regulatory considerations.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 575
Publication type:: Article

Annex 9: Guidelines on clinical evaluation of vaccines: regulatory expectations.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 503
Publication type:: Article

Annex 8: Labelling information of inactivated influenza vaccines for use in pregnant women Addendum to Annex 3 of WHO Technical Report Series, No. 927.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 487
Publication type:: Article

Annex 7: Guidelines on regulatory preparedness for provision of marketing authorization of human pandemic influenza vaccines in non-vaccine-producing countries.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 457
Publication type:: Article

Annex 6: WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 389
Publication type:: Article

Annex 5: Guidelines for the production, control and regulation of snake antivenom immunoglobulins Replacement of Annex 2 of WHO Technical Report Series, No. 964.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 197
Publication type:: Article

Annex 4: Guidelines on estimation of residual risk of HIV, HBV or HCV infections via cellular blood components and plasma.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 163
Publication type:: Article

Annex 3: Guidelines on management of blood and blood components as essential medicines.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 129
Publication type:: Article

Annex 2: Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs).

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 93
Publication type:: Article

Annex 1: WHO Recommendations, Guidelines and other documents related to the manufacture, quality control and evaluation of biological substances used in medicine.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 87
Publication type:: Article

International reference materials - vaccines and related substances.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 81
Publication type:: Article

International reference materials - in vitro diagnostics.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 67
Publication type:: Article

International reference materials - cellular and gene therapies.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 65
Publication type:: Article

International reference materials - blood products and related substances.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 56
Publication type:: Article

International reference materials - biotherapeutics other than blood products.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 51
Publication type:: Article

International Recommendations, Guidelines and other matters related to the manufacture, quality control and evaluation of biological substances.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 28
Publication type:: Article

General.

Published in:: 2017
Publication type:: Proceeding

Introduction.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. 1
Publication type:: Article

Abbreviations.

Published in:: WHO Technical Report Series, 2017, n. 1004, p. xv
Publication type:: Article

Appendix 2: Equilibrium solubility experiments for the purpose of classification of active pharmaceutical ingredients according to the Biopharmaceutics Classification System.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 234
Publication type:: Article

Appendix 1: Recommendations for conducting and assessing comparative dissolution profiles.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 232
Publication type:: Article

Annex 6: Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 181
Publication type:: Article

Annex 5: General background notes on the list of international comparator pharmaceutical products.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 179
Publication type:: Article

Appendix: Hierarchy of regulation.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 177
Publication type:: Article

Annex 4: WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 103
Publication type:: Article

Annex 3: Prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 91
Publication type:: Article

Annex 2: The International Pharmacopoeia: revised concepts and future perspectives.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 87
Publication type:: Article

Annex 1: WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 71
Publication type:: Article

13. Summary and recommendations.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 42
Publication type:: Article

12. Closing remarks.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 41
Publication type:: Article

11. Nomenclature, terminology and databases.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 39
Publication type:: Article

10. Prequalification of priority essential medicines and active pharmaceutical ingredients.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 37
Publication type:: Article

9. Regulatory guidance.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 31
Publication type:: Article

8. Regulatory frameworks.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 29
Publication type:: Article

7. Quality assurance - good manufacturing practices.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 27
Publication type:: Article

6. Quality assurance - collaboration initiatives.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 25
Publication type:: Article

5. Prequalification of quality control laboratories.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 23
Publication type:: Article

4. Quality control - national laboratories.

Published in:: WHO Technical Report Series, 2017, n. 1003, p. 21
Publication type:: Article