COST OF DRUG DEVELOPMENT ASSIGNMENT GRID

Your Name: _______________________________

Source must include a url with a direct link for verification.

Report must be on this form to earn credit. Information must be in each grid block to be evaluated for points for that grid block

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Partial Points are not awarded. Each block of information must be complete to earn points

PART I (34 points)

First Drug Reviewed

(1 point) Salmon calcitonin

List the url source of your information (provide link which can be opened by the instructor)

(3 points)

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htmDrug Company

(3 points) Novartis Pharmaceuticals Ltd

Expected Use of Drug (3 points)

Benefits of the Drug (3 points)

Possible Side Effects of the Drug (3 points)

Used to treat osteoporosis disease.

Helps to regulate calcium and decreases bone loss by inhibiting the activity of specialized bone cells called osteoclasts that absorb bone tissue.

Nausea, skin rash and itching, vomiting and eye pain.

Investigational New Drug Application Clinical Trial Stage

(1 point) Phase I – Basic Safety & Evidence of Activity

Phase II – Efficacy & Proof of Concept

*Phase III – Large, Randomized, Controlled Trials

Phase IV – Post-Marketing Study

Second Drug Reviewed

(1 point) PulmoBind

List the url source of your information (provide link which can be opened by the instructor)

(3 points)

https://clinicaltrials.gov/ct2/show/NCT02216279?term=drugs+currently+in+clinical+trials&rank=6

Drug Company

(3 points) Montreal Heart Institute

Expected Use of Drug (3 points)

Benefits of the Drug (3 points)

Possible Side Effects of the Drug (3 points)

Treatment of Pulmonary Hypertension

Will help in stopping the disease progression or reversing the infection process.

Vomiting, Headache, tiredness, fainting, and diarrhea

Investigational New Drug Application Clinical Trial Stage

(1 point) Phase I – Basic Safety & Evidence of Activity

*Phase II – Efficacy & Proof of Concept

Phase III – Large, Randomized, Controlled Trials

Phase IV – Post-Marketing Study

PART II (16 points)

Find a clinical drug study that is currently seeking participants at ClinicalTrials.gov

Name of Drug Clinical Trails Study

(1 point) Opium

Methadone

Purpose of Study

(3 points) Comparing opium tincture with methadone for the medication-assisted of opioid use disorder (OT-RCT)

List 3 inclusion criteria

(3 points) Patients with opioid use disorder seeking medication-assisted treatment will be recruited. Every participant will be allotted to one of the two study groups, opium tincture (OT) or methadone where there will be an equal chance of receiving either.

List 3 exclusion criteria

(3 points) The research and clinical staff, as well as participants, will not know the medication that each patient will be given.

Estimated Enrollment

(2 points) 200 participants

Why is this study important? Who would it benefit?

What is the study URL?

(4 points)

The study is essential in testing whether opium tincture has similar effects as methadone at retaining participants with opioid use disorder in medication-assisted.

It will be beneficial in the treatment of opium dependence disease.

https://clinicaltrials.gov/ct2/show/NCT02502175?term=clinical+drugs+seeking+participants&rank=7

PART III (25 points)

Reflective Practice and Critical Thinking Essay

In 100 to 250 words and with no more than 3 grammar or spelling errors, state your stand on allowing for-profit companies to develop and market prescription medications? Why or why not?

It is right to allow the profit companies develop and market prescription medications. However, the established drugs for medications must be approved and certified by the FDA’s Center for Drug Evaluation and Research. Companies producing medicines for marketing is sound to both the nation’s social and economic development as the diseases that interferes with human health will be significantly curbed. It portrays that the industries are productive and that they are ready to serve the society through practical research and efficient production of the correct medications. The business-oriented firms cannot be ignored in the medication field as they are profit motivated hence puts all the possible efforts in coming up with the new medications that are not yet established. Some infections such as cancer and Pulmonary Hypertension fatal and leads to enormous deaths in the nation. Therefore, the government based and private sectors working towards developing effective treatment is sound, and their success will save many lives that are under threat of such diseases. Today, the business-oriented areas are substantially participating in the medical field, and they have depicted a significant change that diversifies the research of the emerging and threatening diseases. Therefore, it is the government should work hand to hand with these companies as they play an essential role in offering health services to the public.