Define parallel groups and cross-over design clinical trails

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Reference no: EM133938540

Q1) Several years ago there was extensive coverage in the U.S.A over the pricing of the Epipen® auto-injector for injecting adrenaline (epinephrine) which had increased from USD 165 for a set of 2 in 2011 to USD 609 in 2016, making the life-saving medication (which has only a 12-month shelf-life) unaffordable for many.

It should be noted that the adrenaline is reported to cost ~1c per dose. The high cost is related to the auto-injector for which there were (controversially) no FDA-approved generic equivalents until august of 2018. Hence the company were effectively allowed a monopoly on the product.

a. Why would a situation such as this not arise for consumers in Australia?

b. The current dispensed price for a single dose pen for adrenaline in Australia is $84.21 and there are two brands listed on the PBS? How much is the consumer likely to pay?

Q2) Define 'parallel groups' and 'cross-over design' clinical trials and describe an advantage and a disadvantage for each design?

Q3) The TGA are responsible for both registered and listed medicines. Explain each of these categories and provide an example of a good that falls into each category.

Reference no: EM133938540

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