Reference no: EM131394430
Introduction
The scientific principles and techniques you have learned in this module are routinely applied both in the pharmaceutical industry and in the clinical setting. Two examples are:
1. Analysis of drug formulation quality before clinical testing can take place, for example the confirmation of API identity and product purity.
2. Analysis of drug concentrations in blood for therapeutic drug monitoring (TDM) in patients, for example for a drug with a narrow therapeutic window or in cases where the patient has impaired renal clearance, which may include analysis of the drug and identification of its metabolites in patients taking part in a clinical trial.
In this assignment, we will apply these principles to the drug aciclovir (acyclovir).
PART 1
1. Aciclovir is known to have issues with bioavailability. Discuss the scientific basis of aciclovir treatment with oral dosage forms, with reference to the following:
The issue with bioavailability
The main metabolites of aciclovir.
The issues with neurotoxicity.
Include chemical structures in your answer (guideline 250-300 words plus figures and references).(20% of marks for assignment)
PART 2
2. There are different requirements for the HPLC methods used to analyse aciclovir in a formulation vs. aciclovir in a biological sample such as serum. In this part of the assignment you will compare studies for both senarios.
a. Find a recent journal article on the quantification of aciclovir in tablet formulation using HPLC. Compare and contrast the article you found with the British Pharmacopeia method for quantification of aciclovir tablets in tabular form. Then include a paragraph (guideline 250-300 words) discussing the main disadvantages and advantages of the methods or approachescompared. Your journal article should be attached to the printed paper copy of your assignment and the method highlighted.
b. A link has been provided below to the following article, C.M. McMullin et al. 'a simple high performance liquid chromatography (HPLC) assay for aciclovir and ganciclovir in serum', Journal of Antimicrobial Chemotherapy, (1996) 38 (4); 739-740.Find a more recent journal article on the analysis of aciclovir using HPLC for serum. Compare and contrast for methods in tabular form. Then include a paragraph (guideline 250-300 words) discussing the main disadvantages and advantages of the methods or approaches compared. Your journal article should be attached to the printed paper copy of your assignment and the method highlighted.
https://www.ncbi.nlm.nih.gov/pubmed/8937970
PART 3
3. Some results for the validation of an aciclovir method are shown below, in particular for a calibration curve. Plot the calibration curve and using excel, determine the limits of detection and quantification showing all relevant graphs, data and calculations. Then, with reference to the two journal articles you selected, evaluate if the limits determined would be suitable for both formulation and serum.
HINT: Review ICH Guidelines and Excel LINEST function.
|
Aciclovir Concentration (mg/ml)
|
Peak Height (mAU)
|
|
0.5
|
1043.8
|
|
0.1
|
207.0
|
|
0.05
|
91.4
|
|
0.01
|
16.9
|
|
Find what is the internal rate of return for the project
: A project has an initial outlay of $2,555. It has a single cash flow at the end of year 8 of $4,199. What is the internal rate of return (IRR) for the project?
|
|
Find the mean and standard deviation of the sale prices
: Suppose such cattle sell at auction for 40 cents a pound. Find the mean and standard deviation of the sale prices for all the steers.
|
|
Which would be more unusual a car traveling or one going
: How many standard deviations from the mean would a car going under the speed limit be?- Which would be more unusual, a car traveling 34 mph or one going 10 mph?
|
|
Which would be more unusual a steer weighing or one weighing
: How many standard deviations from the mean would a steer weighing 1000 pounds be?- Which would be more unusual, a steer weighing 1000 pounds or one weighing 1250 pounds?
|
|
Analysis of drug concentrations in blood
: Analysis of drug concentrations in blood for therapeutic drug monitoring (TDM) in patients, for example for a drug with a narrow therapeutic window or in cases where the patient has impaired renal clearance, which may include analysis of the drug ..
|
|
Discuss a swot analysis and provide a detailed explanation
: In the assignment, within a report, you will create a SWOT analysis, discuss a SWOT analysis and provide a detailed explanation of what considerations led to the determination of the SWOT components
|
|
Why would you choose those two particular pieces
: If the museum you are visiting suddenly caught fire, which two pieces of art or exhibits would you most want to see saved from the fire? Why would you choose those two particular pieces?
|
|
What is jumbo juice''s cost of preferred stock
: Jumbo Juice's preferred stock pays a constant dividend equal to $4.75 per share. The firm's marginal tax rate is 40 percent. Jumbo Juice incurs a 5 percent flotation cost each time it issues preferred stock.
|
|
Explain which battery is most likely to last
: If your beach trip is all weekend, and you probably will have the music on for 16 hours, which battery is most likely to last? Explain.
|