Pharmaceutical Science Research Flashcards
Explain the relevance of lab work to pharmacy
Lab work is important in appropriately designing treatments to act on the body, where effectiveness is maximised, and adverse effects are minimised.
Lab work is present is relevant to pharmacy practice, especially in compounding and creating batch sheets. It is also relevant in industrial settings where quality testing and formulation development are necessary.
Outline the SIX priorities that should be considered during the treatment development process
Use the least invasive route possible.
Minimise frequency of administration.
Minimise chances of adverse effects.
Maximum drug-loading in the formulation.
Keep it simple and cheap for manufacturing.
Keep it simple for the patient/practitioner.
Outline the FOUR steps of pre-clinical and clinical laboratory studies
Formulation science - developing a drug delivery system and evaluating its design.
Cell Assays - employs healthy and diseased cells in a petri-dish set-up to test treatment safety first, then efficacy.
Animal Studies - similar to cell testing, but more complex and therefore more impactful. Considers variable dosing and ADME.
Human Studies - used to analyse drug concentration in blood and relevant biomarkers to disease.
Explain the importance of replicates
Science needs to be reproducible – to prove that an effect is happening.
In laboratory studies, experiments are run at least three times.
Statistical analyses are more powerful with a greater number of replicates.
Explain the significance of P-values
The P-value is the probability that two groups are the same. Therefore, for effect to be present (i.e., for two groups to be different), the P-value must be <0.05.
Explain when it would be appropriate to use tables instead of figures to represent data
Tables can be used to simplify data by using numbers to show the magnitude of difference between each group.
This can further be implied by using the mean and standard deviation.
Explain when dissolution testing is used.
During formulation development, dissolution testing determines the rate and extent of drug release from different formulations.
In bioequivalence studies, dissolute testing can establish differences in the drug release rate and extent between the generic and reference products.
In quality testing, dissolution testing can be used to test the consistency of dissolution across different batches
Explain when hardness testing is used.
During tablet formulation development, hardness testing evaluates a tablet’s mechanical strength and integrity. It helps determines its ability to withstand handling, transportation and packaging without breaking or crumbling.
