I will like to play the role of a Biostatician. To be able to involve in clinical research trial design, protocol development, data management, monitoring for safety and efficacy, data analysis and observational studies reporting.

Advantages of clinical studies includes the following: access to new treatments that work, improvement of future treatments and medical knowledge and discovery of fewer side effects compared to the standard treatment.
Disadvantages of clinical studies includes; new discover treatment may not be any better than your current treatment, high risk…[Read more]

Clinical background is essential in clinical studies because majority of the roles you play has something to do with human life and in order to be successful in performing the task you need clinical knowledge. As stated in the question, a statistician for example does not require biological background in analyzing or developing a code for the…[Read more]

The newly completed immunoassay and chemistry analyzer, Atellica Solution, designed to address common clinical laboratory challenges. It integrates immunoassay and clinical chemistry analyzers with the new standard in sample-management technology so you can focus on driving better outcomes. It was never for once advertised on television. The…[Read more]

Vision Statement: Describe the company values and purpose. Also emphasize on desire future of the company
Mission Statement: Defines clearly how the company does business, Its goals and its approach to reach those objectives.
Both Vision and Mission statement are important because they determine the company’s direction. Also serve as a marketing…[Read more]

A clever use of Participation will be through social media. Participation requires brand responses and engagement on at least the major social medias like facebook, twitter, instagram and snapchat. Adidas usage of theme/ hashtag and creative influencer campaigns on social media are the primary reasons to why consumers, most especially millennial…[Read more]

Becton, Dickinson and Company
Financial Report 2016
Revenues $ 12,483
Gross Profit Margin 48.0%
Return on Revenues 7.8%
Return on Total Assets(G) 5.6%
Return on Equity 13.2%
Debt to Capitalization(H) 57.2%
Net Income 976
Operating Income 1,430
Dividends Per Common Share 2.64
Financial Position
Total…[Read more]

If I were to have ownership of a corporation, I would choose Corporation (S Corp. or C Corp.)
Pros
1. Personal asset protection.
2.There is limited liability for business debts and obligations
3. Tax flexibility on personal income.

Cons
1. Financial disclosure to the public.
2. Involves a lot of paperworks
3. Double Taxation if C-Corporation.

Public companies sold all or a portion of itself to the public. It’s Issues publicly traded stock and there is no limits to numbers of shareholder it could has. While, private companies are own by a small numbers of shareholders/ individuals and could does not traded publicly.

Pros for Public
1. Are required to disclose their financial…[Read more]

The company will be better off to exist as an “Inc.” corporation than an “LLC”, first Corporation has limited liability, so the investors and owners are not generally liable for business debts and other liabilities. While an LLC, does has limited liability but Instead, any net profit or loss is “passed through” to the personal tax returns of…[Read more]

I can see how quality is a burden if it’s not well executed, GxP for example which guides quality manufacture, testing, development and approval of drugs. These guidelines ensure that a product is safe and fulfills its intended use. If after product is released, still company sees low customer satisfactory and product had to be recalled. In this…[Read more]

To have a good quality control department the following should be done;
A. Have a document management system in place. This will speed up documentation and no longer have to wait weeks for paper documents to make their way around the office. Documents can be reviewed and approved from anywhere by company departments’ leadership.
B. Mistake…[Read more]

The ways to overcome such shortcoming and making sure procedures are also followed using R&D and Quality team as an example: first, the quality team must have appropriate product-specific technical expertise. They should have experienced in R&D field and contribute to the designing of the product along side the research and development team.…[Read more]

Documentation control involves tracking document changes, revisions, and maintain of relevant versions company’s policies and procedures. This process takes significant amount of time when manaully done. The use of documentation management system would help reduce the lagging time for review and approval of document as this can done from a…[Read more]

What kind of regulatory pathway would be required for an antibiotic-releasing hip stem?
CDRH Regulatory. Class 2 – Special Controls

Is it a device, drug, biologic, or combination?
Combination

What is its “primary mode of action?
Treatment of hip joint infection with hip stem. Releasing antibiotics on a fully weight-bearing implants

Is it Cla…[Read more]

combination product: Vosevi. It is use for treatment of adults with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with mild cirrhosis. It’s department is under Biologics Regulation, CBER. And requires Premarket Approval Application (PMA). A CBER -> IND, (Phase 1,2,3) or Pivotal Trials, B…[Read more]

De Novo classification process involves new, novice unclassified devices using a risk based strategy to determine their class; class I, II or III. An application drafted by Medical Device Sponsor is sent to FDA to determine device type along with classification, regulation, necessary controls and product code if accepted.

De Novo 510K is the…[Read more]

FDA is not rigid instead they’re doing their best to protect public health by assuring the safety and efficacy of drugs. It will be devastating to its mission statement if a life-threatening product is approved and release to market. The government intervened in 1999 and 2012 passing laws to reduce slowing down the process of products.

The new…[Read more]

It’s unethical but was the best method until recent when computer models are developed to simulate human biology. Animals like mice and rats share many physiological and genetic similarities with humans, animal experimentation can be tremendously helpful for furthering medical science. Rats are killed by people when found inside our house, Isn’t…[Read more]

Issues that would need to guard against when outsourcing an animal study to a university located about 1000 mi (1600 km) away from the company are as follow; Poor study design, time management, not enough money, communication and inappropriate bond between a member of the company and the university.
The study model can fail, if this happens it…[Read more]