Describe the attributes of the three phases of FDA Drug Review for Human Testing

Q: Define the Precision Medicine and Disease Diagnostics ?

A: Precision Medicine : A form of medicine that uses information about a person's own genes or proteins…

Q: biomarkers could be used to increase the specificity and sensitivity of DIC diagnosis.

A: Disseminated intravascular coagulation (DIC) DIC is a disorder in which the blood flow is disrupted…

Q: Define the following notions and elaborate on their ethical implications: Stem Cell Tourism.…

A: Some countries offers stem cell based treatment. These countries name include US, China, India, the…

Q: Describe the different types of trials a new drug must undergo before it is “ready for market.”

A: A drug is a chemical substance that produces a biological effect. When the drug is taken by…

Q: Why would it be important to have this kit listed here? Can

A: FDA stands for food and drug administration. FDA is responsible for the protection of public health…

Q: NAME THE COMMON CAUSES OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS IN ABO TESTING

A: Blood group discrepancy develops when the results of red cell typing do not match with plasma typing…

Q: Name some of the relationships between ingredients and health-related conditions that the FDA allows…

A: Health claims are printed on food product labels to tell about the health benefits of certain…

Q: Identify potential barriers to inspection readiness in relation to site inspections in clinical…

A: Inspection readiness is the ability of the organization for operating at a level which effective…

Q: Phase II drug trials are conducted on animals, while Phase III drug trials are conducted on healthy…

A: The Food and Drug Administration (FDA) is a division of the Centers for Medicare and Medicaid…

Q: What is the difference between primary, secondary and tertiary analysis? In oral health provide…

A: Nurses are better able to recognize, individualize, and prioritize nursing diagnoses based on…

Q: What sorts of information counts as "protected health information" under HIPAA?  Give an example of…

A: HIPAA  stands for Health Insurance Portability and Accountability Act and aims at explaining the…

Q: Explain how the practice of radiopharmacy is different from the practice of standard…

A: Radiopharmaceuticals developed very rapidly. It took only about 20 years to develop it as a…

Q: What is the key point related to measurement devices used for validation of the medical device…

A: KEY WORDS :- Medical device - Device used for medical or clinical treatments.

Q: what are the objectives for packaging of pharmaceutical products?  Please answer at your own words.

A: Packaging is a very important part of drug quality. Effective packaging protects the drugs in each…

Q: A new drug has been approved for use, and the drug manufacturer has made it available for sale.…

A: Food and Drug Administration (FDA) is a federal agency established by the state health department.…

Q: Discuss one (1) item of specialized medical test equipment, which would be used during the routine…

A: The care and maintenance of laboratory equipment are an essential part of standard assurance in the…

Q: True positive and true negative are determined using a gold standard, such as an established…

A: A gold standard is an experimental model that is tested thoroughly and has a reputation in a field…

Q: Circle the names of Regulatory Agencies in the following list 1) FDA 2) AAMI/ANSI 3) ANVISA 4)…

A: Regulatory agencies are independent government authorities that can exercise an autonomous dominion…

Q: State whether true or false A bioequivalence test is the same as a clinical trial.

A: A quantitative and qualitative test in which two or more drug mixes are prepared and assessed for…

Q: The Orphan Drug Act provides special patent protection and financial support from the state…

A: A nurse is a trained individual who plays a critical role in the health care by providing care the…

Q: FTE Formula:Number of encountersProductivity rateThe HIM department is transitioning to electronic…

A: FTE (Full-Time Equivalent) is the indicator of the workload of an employee. It is calculated by…

Q: List the types of Premarket Approval (PMA) Supplements. - Explain when each type of PMA Supplement…

A: A PMA supplement is the submission required for a change affecting the safety or effectiveness of…

Q: Compare and differentiate Investigational New Drug (IND) Application from a New Drug Application…

A: In this question it is asking to differentiate between investigational new drug application from a…

Q: A patient has been monitored after coma due to over pills consumption as prescribed. A doctor…

A: Drugs or medication helps in treating the underlying medical condition. The therapeutic effect of…

Q: Discuss the criteria of suitability of a disease for screening

A: Screening of diseases means the active and passive surveillance that can be done by the authorities…

Q: Discuss one of the practical advanced pharmaceutical analysis experiences (about its use in…

A: Pharmaceutical analysis refers to the series of various processes that are used for the analysis of…

Q: Explain the advanatges and disadvantages of savior baby therapy and what are the three main ethical…

A: A savior baby or savior sib is a kid who is planned so as to supply an organ or cell transplant to a…

Q: A drug manufacturer must submit what document with the FDA after completion of Phase lI testing?…

A: The drug is a medicine which causes a change in physiological effect in the body.

Q: Opening your clinic in the morning requires assurance that all equipment and Point of Care Tester…

A: Introduction- Point-of-care testing (POCT) is mainly used as an alternative to central or core…

Q: decli

A: Patients have a set of rights and rules that are meant to be followed by all the hospitals,…

Q: gene therapy in humans and other animals, the types of gene therapy, the methods used, and the…

A: Gene therapy is a medical approach to treat disease including cancer , genetic , or infectious…

Q: Please describe the steps of risk assessment.

A: Risk assessment involves the assessment of the possibility of mishaps and the consequences of…

Q: Discuss the pros and cons of antibiotic use with attention to the overuse or abuse of antibiotics…

A: Some bacterial infections can be treated and prevented by antibiotics. Mild bacterial infections…

Q: A patient is being counseled for possible participation in a clinical trial for a new medication.…

A: Nursing is a practice to provide a systemic and reflective way to approach a patient with…

Q: based from the topic, kindly lists the  - risks, benefits and safety

A: Dysmenorrhea is painful menstruation or difficulty in the menstrual flow. The pain and menstrual…

Q: Please give me a discussion/explanation of (CLINICAL TRIAL) part in drug discovery and development.

A: The pharmaceutical sector is a very significant field nowadays since the discovery of new…

Q: What are the non-examples of controversial medical?

A: Controversial medical is a controversy that arises around the medical treatment developed or…

Q: 1, explain the diagnosis and monitoring aspect of reasoning for ordering laboratory tests. 2,How…

A: We’ll answer the first question since the exact one wasn’t specified. Please submit a new question…

Q: precision medicine vs standard therapy compare the two in details.

A: Therapy is the treatment that aims to resolve the disorders. Precision medicine, sometimes known as…

Q: cenario Benefits (List 3 possible benefits) Costs (List 3 possible costs) Assessment Which do…

A: Nanotechnology is a  new, advanced field of research that aims to build material by using, creating,…

Q: quality assurance

A:

Q: Explain the purpose and aims of a risk assessment

A: Risk assessment is a hazard estimation. It involves the identification of risk and analysis of…

Clinical Pharmacology

Pharmacology is a discipline of medicine that studies how medications interact with the systems and processes of living organisms, focusing on drug action mechanisms as well as therapeutic and other purposes.