Toxicology in preclinical development Flashcards
What considerations need to be taken into account when deciding whether a drug should be marketed or dropped from development?
Safety: The safety profile of the drug is a crucial factor in determining its marketability. If the drug is found to have significant safety concerns, such as adverse effects on vital organs or potential for addiction, it may be dropped from development or restricted in its marketing.
Efficacy: The effectiveness of the drug in treating the target condition is another important consideration. If the drug does not show significant benefits or is not superior to existing treatments, it may not be considered for marketing.
Regulatory compliance: Drugs must meet regulatory requirements before they can be marketed. The regulatory agencies may require extensive clinical trials and data on the drug’s safety and efficacy before granting approval.
Market demand: The potential market size and demand for the drug is also an important consideration. If the drug targets a rare disease or has limited commercial potential, it may not be financially viable for the company to market it.
Manufacturing feasibility: The drug must be manufactured consistently and cost-effectively to be profitable. If the manufacturing process is complex or costly, it may not be feasible to market the drug.
Intellectual property: The company must also consider its intellectual property rights, such as patents and trademarks. If there is a risk of infringement or challenge to the company’s patents, it may not be financially viable to market the drug.
Ethical considerations: The company must also consider ethical aspects of the drug, such as its impact on vulnerable populations, potential for abuse or misuse, and potential conflicts of interest.
What are the major reasons why drugs react differently in the elderly?
Changes in body composition: As we age, our body composition changes, with a decrease in lean body mass and an increase in fat. This can affect the distribution of drugs in the body, leading to higher drug concentrations and increased risk of adverse effects.
Decline in organ function: Many organs involved in drug metabolism and elimination, such as the liver and kidneys, may decline in function with age. This can result in slower drug metabolism and elimination, leading to higher drug concentrations and increased risk of adverse effects.
Increased prevalence of chronic diseases: Elderly individuals are more likely to have chronic diseases such as diabetes, hypertension, and heart disease, which may require multiple medications. The use of multiple medications, or polypharmacy, can increase the risk of drug interactions and adverse effects.
Age-related changes in pharmacodynamics: Age-related changes in receptor sensitivity, enzyme activity, and other pharmacodynamic factors can affect the way drugs work in the body. This can result in altered drug efficacy or increased risk of adverse effects.
Cognitive impairment: Elderly individuals with cognitive impairment may have difficulty adhering to medication regimens, understanding medication instructions, or recognizing and reporting adverse effects.
Which tissue functions should clinicians routinely measure when prescribing statin-type drugs?
Statin-type drugs are commonly prescribed to help lower cholesterol levels in individuals at risk for cardiovascular disease. When prescribing statins, clinicians may routinely measure certain tissue functions to monitor the drug’s effects on the body.
The tissue functions that clinicians may measure when prescribing statins include liver function tests (LFTs), creatine kinase (CK) levels, and kidney function tests. LFTs are used to assess liver function and detect any potential liver damage or abnormalities caused by the medication. CK levels are monitored to detect any muscle damage or injury, as statins may cause muscle-related side effects such as myopathy or rhabdomyolysis. Kidney function tests are used to assess the drug’s impact on kidney function, as some studies suggest that statins may be associated with an increased risk of kidney dysfunction.
Overall, monitoring these tissue functions can help clinicians ensure that the patient is tolerating the medication well and that it is not causing any significant adverse effects. It’s important to note that the specific tissue functions that clinicians monitor may vary depending on the patient’s individual medical history and risk factors.
Why are lifestyle choices important when considering whether to prescribe certain drugs to patients?
