Zoekresultaten - 7 results

Biological reference standards for multivalent vaccines: qualification strategies and challenges from a national control lab perspective

reference qualification reference vaccine Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments ...

Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.

reference. In the development phase, CMC documentation is needed for a candidate challenge agent, while standard operating procedure documentation is needed to monitor and control the manufacturing process, ...

Ensuring batch continuity of non-compendial reference & standard materials from biological origin

Medicines & HealthCare (EDQM),Council of Europe, NA (2016) Keywords: meeting ORIGIN STANDARD Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical ...

Detection and risk evaluation of counterfeit medicines based on physico-chemical properties: the fingerprint and chemometrics approach

fingerprinting has been shown to be useful to screen herbal preparations for the presence of forbidden or regulated plants. The disadvantage of this approach is that a reference standard of the targeted plants ...

Establishment of the Ph. Eur. BRP for varicella vaccine batch 1.

Antibodies, Viral Chickenpox Vaccine Europe Freeze Drying Herpesvirus 3, Human Humans Pharmacopoeias as Topic Reference Standards Reproducibility of Results Abstract: The European Pharmacopoeia (Ph. Eur.) ...

Official analysis of suspected illegal dietary supplements: reference standard or no reference standard, that’s the question

Publication Type: Scientific poster, presentation or proceeding Authors: Source: (0) Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et pr ...

Use of non compendial reference standard for multi-valent vaccines

Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin; Silvana Bellini Source: 13th international symposium on pharmaceutical reference standard, EDQM, Strasbourg ...

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