Final Exam Flashcards
What are the three main elements of a drug conjugate?
- A targeting moiety or ligand that typically detects a targeted receptor on a cancer cell.
- Payloads which are highly potent toxins intended for release inside the cell.
- Specialized linkers which attach the payload to the targeted moiety and are intended to cleave inside the cell.
What separates the action of ADCs from TDCs?
An ADC links a payload first to an antibody, whereas a TDC delivers the payload directly to the targeting moiety of a tumor which offers a more precise and direct delivery system.
What is structure-based drug design?
The process of utilizing a molecule’s chemical and stereochemical structure to mold it into a drug which can more effectively “hit” its target.
What is observed in ligand-fit analysis?
How well the target substance binds with its target, i.e. hydrogen bonding, hydrophobic interactions, electrostatic interactions, and bioactive conformity.
How is Gleevec used to treat cancer?
Gleevec binds to the Bcr-Abl protein and inhibits its ability to catalyze phosphorylated cancer proliferation.
What factors other than ligand binding are important in structure-based design?
Keeping the drug from binding to other irrelevant receptors and to maintain drug-like properties (i.e. lipinski rule of 5).
What are the 6 main elements of a clinical research project?
Research question, Background and significance, design, participating subjects, variables, and statistical analysis.
What is a clinical trial?
A scientific study of a drug which involves human subjects in which a drug is offered as an intervention to study its efficacy and safety.
What information is to be discovered from clinical trials?
- Effectiveness of treatement
- Safety
- Dose
- Drug Formulation
- Combined therapies
- Effect of therapies on quality of life
True or False? Bias can be quantified.
Usually False
What are the benefits of randomizing control groups?
Eliminates bias, and provides an accurate estimate of random error.
What is a medical device?
Any device, tool, or component part designed to diagnose, treat, or otherwise mitigate the effect of a disease, and which does not achieve effectiveness through chemical means and does not need to be metabolized.
What is the difference between a pilot study and a pivotal study in medical device trials?
A pilot study is the initial study of the device to ensure safety; it is only done with fewer than 100 patients. A pivotal study is done to determine effectiveness of the device.
What is the difference between a high and low risk medical device?
Low risk devices are not sterile, are non-invasive, and do not measure things. High risk devices are life-sustaining, invasive, and/or may produce radiation.
What are some examples of class II (moderate risk) medical devices?
Powered wheelchairs, infusion pumps, and surgical drapes.
What is a 510K?
An application to the FDA for a medical device to be cleared for use. Predicate devices can be cleared in as little as 90 days.
What is PMA?
Thorough review by CDRH or in concert with CBER, CDER for design, manufacturing – can take up to 2 years
What does De Novo refer to?
A new technology never before seen by the FDA.
What is an IDE?
FDA grants permission to a sponsor to study an investigational device clinically.