Question

These are all pharmacy related questions

what are the roles of the key functions in drug development operations.

what are the group reviews protocols for all studies in humans.

what is homologous, isomorphic and predictive animal models are.

what is the main goal of and the activities that support that goal during preclinical testing

what are the requirements for informed consents

Answer 1

Q) 1)WHAT ARE THE ROLE OF THE KEY FUNCTION OF DRUG DEVELOPMENT OPERATIONS.

2)WHAT ARE THE GROUP REVIEWS PROTOCOLS FOR ALL STUDIES IN HUMANS.

3)WHAT IS HOMOLOGOUS, ISOMORPHIC AND PREDICTIVE ANIMAL MODELS ARE.

4)WHAT IS THE MAIN GOAL AND THE ACTIVITIES THAT SUPPORT THAT GOAL DURING PRECLINICAL TESTING.

5)WHAT ARE THE REQUIREMENTS FOR INFORMED CONSENTS.

Ans) 1)  Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes pre-clinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.

2) a) recruitment methods

b) inclusion and exclusion criteria

c) study endpoints

d) procedures involved in the human research

e) data and specimen management

f) Provisions to monitor the data for the safety of participants

g) Withdrawal of participants

3) a) homologous animal :Homologous animals have the same causes, symptoms and treatment options as would humans who have the same disease.

b) Isomorphic animals share the same symptoms and treatments.

c) Predictive models are similar to a particular human disease in only a couple of aspects, but are useful in isolating and making predictions about mechanisms of a set of disease features

4) Main goal and activities of pre-clinical testing:

*) In drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected.

*)The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools.

*)On average, only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug

5) Valid informed consent for research must include three major elements:

(1) disclosure of information,

(2) competency of the patient (or surrogate) to make a decision, and

(3) voluntary nature of the decision.