If you were a member of the drug development committee at a pharmaceutical sponsor, how would...

If you were a member of the drug development committee at a pharmaceutical sponsor, how would you draft a package insert indication for a new lipid lowering drug that is proven more potent than atorvastatin. The new drug is called lowerstatin.

Expert Solution

Package insert:

Printed materials available in the legal pharmacologic description of a drug, subject to detailed regulatoryspecifications, including approved chemical and proprietary names, description and classification, clinicalpharmacology, approved indications and usage, contraindications, warnings, precautions, adverse reactions, drugabuse and dependence information, overdosage discussion, dosage and administration, formulations, and appropriate references

The first thing listed is usually the brand name and generic name of the product. The other sections are as follows:

Clinical pharmacology - tells how the medicine works in the body, how it is absorbed and eliminated, and what its effects are likely to be at various concentrations. May also contain results of various clinical trials (studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.).
Indications and usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure). Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called "off-label uses").
Contraindications - lists situations in which the medication should not be used, for example in patients with other medical conditions such as kidney problems or allergies
Warnings - covers possible serious side effects that may occur
Precautions - explains how to use the medication safely including physical impairments and drug interactions; for example "Do not drink alcohol while taking this medication" or "Do not take this medication if you are currently taking MAOI inhibitors"
Adverse reactions - lists all side effects observed in all studies of the drug (as opposed to just the dangerous side effects which are separately listed in "Warnings" section)
Drug abuse and dependence - provides information regarding whether prolonged use of the medication can cause physical dependence (only included if applicable)
Overdosage - gives the results of an overdose and provides recommended action in such cases
Dosage and administration - gives recommended dosage(s); may list more than one for different conditions or different patients (e.g., lower dosages for children)
How supplied - explains in detail the physical characteristics of the medication including color, shape, markings, etc., and storage information (e.g., "Do not store above 95°")

Nightingale answered 1 year ago

Wilson pharmaceutical is planning a 100 million for development of a new cancer drug. the development...

Wilson pharmaceutical is planning a 100 million for development of a new cancer drug. the development will be financed with a combination of debt preferred equity and common equity. the firms current capitol structure which considers to be optimal consists pf 30% debt 20% preferred equity and 50% common equity. the firm can issue bond with a cost of 12% before tax. the investment banker expects to sell the issue at its $100 par value per stock with a $14...

If you were going to run a business with a family member, how would you go...

If you were going to run a business with a family member, how would you go about deciding on the organizational culture you want to create?

If you were a member of Congress, how would you propose to balance the budget? Do...

If you were a member of Congress, how would you propose to balance the budget? Do you think your proposal could pass Congress? Do you think you'd be able to be re-elected if it did? Defend your opinions. This is in Statistical Reasoning.

1. If you were to take a drug that depressed the nervous system how would that...

1. If you were to take a drug that depressed the nervous system how would that effect the ability to increase blood pressure when you needed to and how would heart rate respond?

You are a member of the committee that will determine the needs for a new pharmacy...

You are a member of the committee that will determine the needs for a new pharmacy system for the hospital. Describe in about 10-12 lines the steps of the process and the important issues which the committee should study during the "needs assessment phase" of the project.

A) If you are a member of infection control committee of a hospital, what are the...

A) If you are a member of infection control committee of a hospital, what are the strategies should be followed in antibiotic treatment and why?

If you represented an insurance company or competing pharmaceutical manufacturer, how would you respond to the drug price increases imposed by Turing Pharmaceuticals?

If you represented an insurance company or competing pharmaceutical manufacturer, how would you respond to the drug price increases imposed by Turing Pharmaceuticals? Given the absence of limitations on how much a company can charge for a given product, does the increase in the price of Daraprim create justification for the imposition of price controls at times? How does this intersect with the idea that a free-market economy dominates in America?

1: Assuming that you have been appointed as a strategic management committee member, discuss how the...

1: Assuming that you have been appointed as a strategic management committee member, discuss how the different processes have affected into your strategic management process of the focal company. 2: Why would you feel strategic management should be more a top-down or bottom-up process in a firm? Explain and support your rationale.

Jessica Smith is the vice president of new drug development at Generic Phama, Inc, a pharmaceutical...

Jessica Smith is the vice president of new drug development at Generic Phama, Inc, a pharmaceutical research company in Boston, Massachusetts. One year ago, she filed an application with the Food and Drug Administration (FDA) to obtain approval of a new drug for treating cancer. Smith met Joe Spencer at a convention three months ago and invited him to her room at the hotel. The two parted ways. Spencer worked as the director for approval of new drugs at the...

You are a member of a committee that will select a Physician Practice Management System. What...

You are a member of a committee that will select a Physician Practice Management System. What can you expect to observe when you evaluate the scheduling capabilities of the Physician (Answer must be 20 lines)

Question