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Explain the importance of tamper-evident packaging in ensuring the safety and integrity of pharmaceutical products.
Step by step
Solved in 3 steps
- Identify the criteria the compounds must meet in order to be developed into drugs.Describe the FDA approval process for assessing the safety and efficacy of a newly developed drug. What are advantages and disadvantages of this process?Explain the role of different toxicological parameters (i.e. ED50, TD50, LD50, NOAEL, LOAEL, etc.) in ensuring the safety of a drug candidate.
- Describe three situations where you would use an excipient in your drug formulation and how you expect the excipient to help in the very of the active pharmaceutical ingredient.Outline some important factors to consider in drug therapy.consider a patient-specific example of how lack of knowledge pertaining to pharmacology could negatively impact patient care. Discuss how the lack of knowledge could contribute to errors and ineffectiveness of a drug.
- Based on the device classification provide a few sentences for device-specific FDA requirements, and regulations.Briefly define the role of cGMP for the quality control unit in the pharmaceutical industry ? Please answer at your own easy words.TRUE OR FALSE Properties of a drug suitable for transdermal use include: High molecular mass Low lipophilicity Low required daily dose Low potency High partition coefficient Problems with opioid TDDS include: Poor patient compliance Allergy Constipation Respiratory depression Cognitive dysfunction