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pro vyhledávání: '"David Roesti"'
Autor:
David Roesti
Publikováno v:
Pharmaceutical Microbiological Quality Assurance and Control
Autor:
Oliver Gordon, David Roesti
Publikováno v:
Pharmaceutical Microbiological Quality Assurance and Control
Autor:
Marcel Goverde, David Roesti
Publikováno v:
Pharmaceutical Microbiological Quality Assurance and Control
Autor:
David Roesti
Publikováno v:
Pharmaceutical Microbiological Quality Assurance and Control
Autor:
Marcel Goverde, David Roesti
Publikováno v:
Pharmaceutical Microbiological Quality Assurance and Control
Publikováno v:
Journal of Applied Microbiology. 122:997-1008
Aims The aim of this study was to develop and evaluate a real-time PCR technology for microbiological control methods to examine individualized cell therapeutics, an emerging class of pharmaceutical formulations. Methods and Results Oligonucleotide p
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 71:206-224
This article reports the validation strategy used to demonstrate that the Milliflex® Quantum yielded non-inferior results to the traditional bioburden method. It was validated according to USP , Ph. Eur. 5.1.6 and PDA Technical Report No. 33 and com
Autor:
David Roesti, Marcel Goverde
Relying on practical examples from the authors'experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidan
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 69:383-398
In the present work we compared different calculation approaches for their ability to accurately define microbiological control levels based on historical data. To that end, real microbiological data were used for simulation experiments. The results
Publikováno v:
PDA journal of pharmaceutical science and technology. 71(3)
This article reports the validation strategy used to demonstrate that the Milliflex