Drugs Analysis Tools Flashcards
Analysis Types
Chemical, Physical and Microbiological
Analysis Applications
Quality Testing (whether sample = label), stability testing (shelf life/half life), compatibility testing (interaction with body/other medicines), drug ID (qualative), drug characteristics (quantative), bioanalysis (pharmacological effects), drug isolation from samples
What manufacturers test for
is it pure, safe, functional
Bioanalysis Def
Analysis of a drug in a biological specimen. Eg in blood, in respiration, LADME profiles
2 errors in bioanalysis
Sample prep (not correctly isolated) and machine error (eg wrong settings
Area under curve in Bioanalysis Graph
Concentration of drug absorbed
Bioanalystic Science Def
Study of analysing biological/non samples using biological methods
Preformulation Def
Prediction of drug characteristics before formulation
Quality Asssurance and Quality Control Outline
Ensure quality, purity, safety and effectiveness of drug products
Specifications Def
Lists of tests (eg stability, solubility), references analytical procedures and acceptable criteria (numerical ranges). Establish quality guidelines
Tablet tests
Disintegration, Friaing, Hardness and dissolution
Qualitive Analysis Def
Looking at substance (eg it’s substituents) to identify it and ascertain nature of constituents
Quantitive Analysis Def
Substance analysis of amount and proportions of chemical constituents
Accuracy Def
The closeness of a sample value to the true value of population (mean)
Precision Def
Closeness of sample value to other values within in the samples