Drug development of Biologics // Drug Repurposing

Drug development of Biologics

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Regulatory Compliance is the level of activity that provides assurance to the sponsor and the regulatory agency that all phases of drug development are conducted in compliance to the good practice regulations as mandated by the Federal Food, Drug, and Cosmetic (FD&C) Act. In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations for biologics and drug development. You will also examine how a pharmaceutical or biotechnology company can use the graded approach when following the good manufacturing practice (GMP) regulations for manufacturing, testing and control of clinical supplies and commercial products.

Course Number: BIOL-40101 Credit: 2 units

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Section ID Fee Status
Closed
Location: ucsdextension.blackboard.com
You will have access to your course on the published start date.
Class Type: Online—web-based instruction
Instructor: K A Ajit-Simh, President, Shiba Biotechnology

Textbooks: No information available at this time.

Location: ucsdextension.blackboard.com
You will have access to your course on the published start date.
Class Type: Online—web-based instruction
Instructor: K A Ajit-Simh, President, Shiba Biotechnology
Location: ucsdextension.blackboard.com
You will have access to your course on the published start date.
Class Type: Online—web-based instruction
Instructor: K A Ajit-Simh, President, Shiba Biotechnology

http://www.ikeaukraine.com

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Many Americans have wondered why prescription drugs have become so expensive while advertising for those drugs seems to grow exponentially. Former New England Journal of Medicine Editor Marcia Angell has some answers. The pharmaceutical industry, according to Angell, is fraught with corruption and doing a disservice to customers, the federal government, and to the medical establishment itself. In The Truth About the Drug Companies, Angell explains how a huge portion of the revenue generated by "Big Pharma" goes not into research and development but into aggressive marketing campaigns to sell their product

Covance does drug development

by muppetdog

Covance helps pharmaceutical and biotech companies of all sizes fulfill their research and development, clinical trial, regulatory and marketing-support needs.
To the biopharmaceutical sector, we provide a broad spectrum of services from nonclinical testing, through 'first in human' and late stage clinical trials, all the way to commercialization. Covance is the leading provider of central laboratory testing and cardiac safety services to support the clinical trial process.
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by Hydrogyrophage

Started every year. They're just not the same as Big Pharma.
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There are companies that specialize in various stages of drug development. Some focus on basic research, make patents, and license them to another company that does clinical trials. Some companies focus on phase 0, 1, and maybe 2 clinical trials

Regarding generic drugs

by magicthighs

I appreciate the arguments you make for brand name drugs and the necessity to recoup the infrastructure and development costs for the important research that is being done- I agree with much of what you wrote.
But here is where I disagree with your assertion regarding generic drugs and comparing Mercedes to a Kia. All generic drug companies are monitored by the FDA as much as a brand name company. They all have to adhere to very strict cGLP, cGMP, 21 CFR 11 protocols. These companies are audited as much as brand name companies (if not more) and the products coming out of these companies are as pure as any coming out of a brand name company

Drugs are expensive to get to market.

by redhead_dogs

There are costs of research, development, various studies, and satisfaction of our gov't that need to take place before a drug can get to market. It takes years. Different drugs have different lengths of time for which a patent applies. It is during this patent time that a drug company hopes to make back the money they spent developing the drug. Generics can only be made once the patent for the original expires.
Heartgard already has generics on the market. Interceptor will likely have them too if still a promising drug when the patent expires if anyone else thinks it is still worth making the drug (newer drugs are always being developed so what is seen as great now may not be seen as so great in 2010).

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