Good Laboratory Practice
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Recent papers in Good Laboratory Practice
The aim of this document is to provide guidance on the validation of computerised systems, compliant with Good Laboratory Practice (GLP). It specifies more precisely the procedures to follow in carrying out validations of computerised... more
Overview of the apporach to non-compliances and related matters. Appropriate training for analysts on how to perform the tests and steps to take when obtaining OOS results should be implemented . The use of root cause analysis tools when... more
Flow cytometry is a powerful and flexible analytical tool used during all stages of drug development. While substantial effort is invested in development and validation of analytical methods, instrument validation is often neglected. Flow... more
The aim of the present document is to provide guidance on the Good Laboratory Practice (GLP)-compliant acquisition and processing of electronic raw data. The life cycle of electronic raw data and their related meta data from the data... more
GOOD LABORATORIUM PRACTICES DI LABORATORIUM PENGOLAHAN
Cell transformation models have been established for studying the cellular and molecular basis of the neoplastic process. Transformation models have also been utilized extensively for studying mechanisms of chemical carcinogenesis and, to... more
Surrogate antibodies are a potential solution to the limited safety testing possible with humanized monoclonal antibodies with restricted species cross-reactivity. However, there are currently no defined criteria by which a potential... more
This paper presents the design, optimization, realization and verification of novel whole-body exposure setups for rats. The setups operating at 902 MHz and 1747 MHz provide highly efficient, National Toxicology Program (NTP) compatible... more
The pharmacokinetics and pharmacodynamics of danofloxacin in calves with induced Mannheimia (Pasteu- rella) haemolytica pneumonia were evaluated. Calves received either saline as an intravenous (IV) bolus or danofloxacin (0.738 mg/kg of... more
Our laboratory has previously reported a flow cytometric acridine orange method for detection of micronucleus (MN) in the rat using cyclophosphamide as a test compound. To replace the manual method of scoring and satisfy Good Laboratory... more
Page 1. 279 A Tale of Two Pathologists: Questions on Good Laboratory Practice Two pathologists (A and B) meet with the Head of Department to discuss the establishment of a new molecular biology-based clinical test, which ...