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Author Archives: Anonymous

An AP of the knee is produced with an SID of 72” and an OID…

An AP of the knee is produced with an SID of 72” and an OID of 10”. What is the percentage of magnification?

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The weekly demand for a drinking-water product, in thousands…

The weekly demand for a drinking-water product, in thousands of liters, from a local chain of efficiency stores is a continuous random variable XX with the probability density function f(x)={2(x−1),1

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The total number of hours that a family runs a vacuum cleane…

The total number of hours that a family runs a vacuum cleaner over a period of one year is a continuous random variable XX with the density function: f(x)={x,0

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The proportion of people who respond to a certain mail-order…

The proportion of people who respond to a certain mail-order solicitation is a continuous random variable XX with the density function f(x)={2(x+2)5,0

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Suppose that the error in the reaction temperature (in °C) f…

Suppose that the error in the reaction temperature (in °C) for a controlled laboratory experiment is a continuous random variable XXX having the probability density function: f(x)={x23,−1

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[22 marks]Racetam® is a newly registered anticonvulsant medi…

[22 marks]Racetam® is a newly registered anticonvulsant medicine, authorised in 2020 for the management of epilepsy in South Africa. In accordance with regulatory requirements, the holder of a certificate of registration (HCR) must provide updates at defined intervals to SAHPRA to ensure that the benefit–risk balance of Racetam® remains favourable during its life cycle. During the review of the most recent periodic safety update report (PSUR), severe respiratory depression was identified as an important identified risk. Populations considered to be at increased risk include individuals with compromised respiratory function, pre-existing neurological or respiratory disease, renal impairment, those on concomitant central nervous system (CNS) depressants, and the elderly. Additionally, Racetam® has been noted to have potential off-label use in the management of nerve pain, insomnia, and anxiety, raising concern over unsupervised use and possible adverse outcomes.5.1 Discuss the role of the PSUR in monitoring and analysing new or emerging information on the risks and benefits of Racetam®. Your response should explain the regulatory purpose of the PSUR in post-marketing surveillance and how it supports detection and assessment of new safety signals, such as severe respiratory depression. (8 marks)5.2 Propose routine and additional risk minimisation measures that could be applied for all patients and for specific high-risk groups to minimise the risk of severe respiratory depression associated with Racetam®. Your response should also explain how these measures are documented, monitored and updated. (14 marks)

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[12 MARKS]A 10-year-old girl received a dose of new conjugat…

[12 MARKS]A 10-year-old girl received a dose of new conjugate vaccine. Within 12 hours, she developed a high-grade fever (39.5°C), malaise, and a generalised maculopapular rash. Her parents took her to the emergency department, where she was treated symptomatically and recovered fully within two days. The girl was not on any medication, and no underlying conditions were reported. Laboratory investigations showed no evidence of bacterial or viral infection. A few similar reports have been received nationally following administration of this vaccine. The national pharmacovigilance centre has been requested to assess the causal relationship between the vaccine and the reported adverse event.2.1 Using the key criteria and principles of causality assessment in vaccine safety surveillance, evaluate the likelihood that this vaccine caused the reported adverse event. (7 marks)2.2 Discuss why causality assessment is crucial for vaccine safety surveillance and regulatory decision-making. (5 marks)

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Which of the following is not true of magazines?

Which of the following is not true of magazines?

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Colonial magazines were a great success because they carried…

Colonial magazines were a great success because they carried a great deal of advertising.

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During the Civil War:

During the Civil War:

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