Medicine and drug quality Flashcards
What is the significance of drug and medicine quality?
Ensures safety, efficacy, and trust in healthcare; poor quality can lead to treatment failure and harm.
What is the purpose of a pharmacopeia?
To provide legal and scientific standards for medicine identity, strength, quality, and purity.
What are fundamental terms of pharmaceutical analysis?
Accuracy, precision, selectivity, sensitivity, linear range, limit of detection, limit of quantitation, and error.
What are different types of error in analytical measurements?
Systematic error and random error; both affect reliability and accuracy of measurements.
How do you conduct calculations related to error and uncertainty?
By using standard deviation and relative standard deviation (RSD) to assess data variation and reliability.
What are potential sources of error in analytical measurements?
Raw materials, manufacturing processes, equipment, instability, and contamination.
Who ensures the quality of medicines?
Regulatory authorities, doctors, pharmacists, patients, and pharmaceutical companies.
What is a substandard medicine?
A medicine that does not meet quality standards or specifications.
What is a falsified medicine?
A medicine that deliberately misrepresents its identity, composition, or source.
Why are substandard and falsified medicines a global issue?
They compromise treatment, increase resistance, and are prevalent, especially in low- and middle-income countries.
Which medicines are commonly affected by substandard and falsified issues?
Anti-malarials and antibiotics.
Are generic and innovator medicines both affected?
Yes, both can be substandard or falsified.
What is the estimated prevalence of poor-quality medicines in LMICs?
About 1 in 10 medical products.
What does pharmaceutical analysis involve?
Purification, separation, identification, and qualification of pharmaceutical substances.
What types of analysis are involved in pharmaceutical analysis?
Chemical, physical, and microbiological analysis.
What is qualitative analysis?
Identifying the components present in a substance.
What is quantitative analysis?
Determining the amount or concentration of a substance.
What can pharmaceutical analysis reveal about a drug’s identity?
Whether the correct drug is present in the formulation.
Can pharmaceutical analysis detect impurities?
Yes, it checks for both the presence and levels of impurities.
Can pharmaceutical analysis determine drug stability?
Yes, it evaluates how long a drug maintains its intended quality.
Can pharmaceutical analysis assess drug release rates?
Yes, it measures the rate at which the drug is released from its formulation.
What are drug concentrations in biological fluids used for?
To monitor therapeutic levels and pharmacokinetics.
What is chemical purity?
The absence of foreign matter; no substance is absolutely pure, but acceptable impurity levels are defined.
What factors affect acceptable impurity levels?
Purification method, product stability, impurity toxicity, and dosage of the active ingredient.
