Lecture 3 Preclinical Testing Flashcards
What is GMP?
a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. Guidelines that outline the aspects of production and testing can impact on the quality of a product
What is GLP?
a system of management controls for
laboratories and research organizations to ensure the consistency and reliability of results
What is GCLP?
a framework for a quality system in analysis of clinical trial samples, ensuring GCLP compliance overall of processes and results
What are the procedures done under non-GLP/GMP settings?
Slide 5
What are the procedures done under GLP/GMP settings?
Slide 6
What is the purpose of CMC?
Slide 8 and 9
What are the different ways to optimize analytical method development? (Under ADME)
Slide 12, 13
- to quantify the concentration of drug/metabolites (HPLC can see molecular structure and define if is drug/metabolite) at that particular timepoint to determine t1/2 / F / Vd
What are the key criteria for validation of assay before approving the assay for GLP studies?
Slide 14
What needs to be tested under bioavailability?
Slide 15, 16
What needs to be tested for metabolism and why do we need to do it this way?
Slide 17
How and why do you perform toxicology evaluation (general)?
Slide 19
What is the purpose of conducting single-dose (acute) toxicity?
Slide 20
How do you conduct repeated dose toxicity?
Slide 21
How do you conduct acute toxicity and repeated dose toxicity for GLP standard + Actual expt procedure)?
Slide 23, 24 (Actual procedures)
What are the assays to be conducted for genotoxicity testing? (GLP)
Slide 26, 27, 28, 29
