Comparison between in vitro potency tests for Cuban Hepatitis B vaccine: contribution to the standardization process

Author:

Cuervo Mario Landys Chovel,de Castro Yanes Ania Fernández

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference15 articles.

1. Requirements for valid alternative assays for testing of biological therapeutic agents;Sesardic;Development in Biological Standardization,1996

2. Validation of alternative methods for the potency testing of vaccines. The report and recommendations of ECVAM workshop 3l;Hendriksen;ATLA,2001

3. Alternatives to animal testing in the quality control of immunobiologicals: current status and future prospects. The report and recommendations of ECVAM workshop 4;Hendriksen;ATLA,1994

4. Assuring the quality of vaccines: regulatory requirements for licensing and batch release;Griffith,1996

5. Annex 4: requirements for hepatitis B vaccines made by recombinant DNA techniques;WHO,1999

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