Author Box
Articles Categories
All Categories
Articles Resources

Significant Events in the History of Pharmaceutical Testing

June 15, 2012 | Comments: 0 | Views: 218

In the 10th century, the great Persian medical thinker Ibn Sina proposed what might be called, in today's parlance, pharmaceutical quality assurance guidelines: medicines must be tested on animals before on humans, medicines used in experimental trials must be unadulterated and pure, etc. But the field of pharmaceutical testing didn't really take off until the 20th century, when the industrialized countries saw the need to regulate food and drug quality assurance and quality control.

1906 - The United States Congress passed the Pure Food and Drug Act. This law established labeling requirements for drugs. One small step for man, one giant leap for pharmaceutical quality assurance! But there was still a long way to go.

1908 - Canadian Parliament passed the Proprietary and Patent Medicine Act, which prohibited the use of cocaine in medicines and required drug companies to indicate on the label if heroin, morphine or opium was an ingredient. A small but significant nod to quality assurance and quality control

1937 - The U.S. Congress passes the Food, Drug and Cosmetic Act requiring drugs to submit to pre-market pharmaceutical testing. This milestone in quality assurance and quality control came about as the result of a tragedy known as the Elixir Sulfanilamide Incident, where a new formulation of a drug used to treat strep infections was prescribed to patients without being tested, resulting in the deaths of more than 105 people in fifteen states. For the first time, The Food and Drug Administration concerned itself with quality assurance and quality control for new drugs.

1948 - The Nuremberg Code laid the groundwork for ethical pharmaceutical testing on human participants. The Code specified that human volunteers must be informed and protected from harm - a clear indictment of the practice of conducting experiments on prisoners of war.

1950s and '60s - Various countries, including the United States, Germany and Britain, reacted to the thalidomide baby tragedy by enacting new rules governing the reporting of adverse drug effects and clinical trials. In Canada, the tragedy led to a long overdue requirement for drug manufacturers to prove efficacy before proceeding to market.

'80s - The United States government developed an incentive program for pharmaceutical companies to pursue pharmaceutical testing and development in areas with fewer patients, i.e., to cater to less lucrative but needy markets.

In the same decade, perhaps in response to the HIV crisis, the pharmaceutical quality assurance process was fast tracked for certain drugs intended to treat conditions for which no other drug alternative existed.

1996 - New international standards for drug quality assurance and quality control were spelled out at an International Conference on Harmonization held in Brussels.

As for the future of pharmaceutical quality assurance, no one can say with any certainty what it holds.

Visit AAPS for more information on online learning.

Rima Hammoudi is a Copywriter at Higher Education Marketing, a leading Web marketing firm specializing in Google Analytics, Education Lead Generation, Search Engine Optimization (SEO), Mobile SMS Alerts, Social Media Marketing and Pay Per Click Marketing, among other Web marketing services and tools.

Source: EzineArticles
Was this Helpful ?

 
0
 
0
 
Rate this Article
 vote(s)
Feedback
Print
Re-Publish

Article Tags:

Pharmaceutical Quality Assurance

,

Pharmaceutical Testing

,

Pharmaceutical Quality

,

Quality Assurance

For gaining entrance in coveted fields in a reputed University, the entrance examinations are the gateway. The purpose of these entrance examinations is to test the potential of a candidate and how

By: Sarkariexam l Reference & Education > Science l December 23, 2012 lViews: 519

Competition is increasing at an alarming level in every sphere. The students have to focus completely on their studies to ensure that they get admission in the line of their choice. What more, the

By: Sarkariexam l Reference & Education > Continuing Education l December 14, 2012 lViews: 1443

'How hard is a PhD'? Many PhD holders have been asked this question millions of times, but there is never any definite answer. We look at those who walk around proudly with a 'Doctor' title with

By: onlineedublog l Reference & Education > Continuing Education l November 11, 2012 lViews: 284

In this fast paced world which is sadly recession struck, it is indeed a good idea to work while acquiring further education. A master’s degree is obviously better than a bachelor’s in almost

By: onlineedublog l Reference & Education > Online Education l November 04, 2012 lViews: 262

An Online Degree Program in Finance is gaining popularity as it helps students to develop a lucrative career. It helps in a competitive business world. This has resulted in more number of students

By: Matthew l Reference & Education > Online Education l October 31, 2012 lViews: 287

Supporting justice is one of the reasons many people get into a career in the legal field. All-inclusive Online Associate’s Degree in Legal Studies assists many in the beginning stage of employment

By: Richard l Reference & Education > Online Education l October 26, 2012 lViews: 221

So you’ve thought of a degree program that you’ll be pursuing at college, and now you are down to college shopping. Your choice varies widely from online colleges to the traditional university,

By: Richardl Reference & Education > College Universityl October 25, 2012 lViews: 218

This article outlines the tips to help you write a high quality technology term paper. It outlines simple to understand tips that will help you earn top grades in your term paper. Regardless of the

By: Bradley Johnsonl Reference & Education > College Universityl October 24, 2012 lViews: 162

What do Cost of Quality, Zero Defects and Total Quality Management (TQM) have in common? They are all concepts in quality assurance and quality control that emerged in the second half of the 20th

By: Rima Hammoudil Reference & Education > College Universityl June 15, 2012 lViews: 216

Three names that you may have never heard of, but that help keep you safe when you go to the pharmacy or grocery store. Pioneers in quality assurance and quality control.

By: Rima Hammoudil Reference & Education > College Universityl June 15, 2012 lViews: 242

Before there was the Food and Drug Administration, there was the Bureau of Chemistry, which, under the leadership of Harvey Wiley, hastened the emergence of food and pharmaceutical testing, but using

By: Rima Hammoudil Reference & Education > College Universityl June 15, 2012 lViews: 229

What to expect from Scottish universities. A brief guide to where and what you could be studying up north.

By: Harvey McEwanl Reference & Education > College Universityl June 13, 2012 lViews: 197

What do Cost of Quality, Zero Defects and Total Quality Management (TQM) have in common? They are all concepts in quality assurance and quality control that emerged in the second half of the 20th

By: Rima Hammoudil Reference & Education > College Universityl June 15, 2012 lViews: 216

Three names that you may have never heard of, but that help keep you safe when you go to the pharmacy or grocery store. Pioneers in quality assurance and quality control.

By: Rima Hammoudil Reference & Education > College Universityl June 15, 2012 lViews: 242

Before there was the Food and Drug Administration, there was the Bureau of Chemistry, which, under the leadership of Harvey Wiley, hastened the emergence of food and pharmaceutical testing, but using

By: Rima Hammoudil Reference & Education > College Universityl June 15, 2012 lViews: 229

You may already know that high-performance liquid chromatography courses teach students how to identify and separate the individual components of a compound using a pump. But did you know that this

By: Rima Hammoudil Reference & Education > Vocational Trade Schoolsl May 24, 2012 lViews: 175

HPLC is a kind of a laboratory testing that requires training to truly understand. What can beginning students expect to encounter in their first HPLC courses?

By: Rima Hammoudil Reference & Education > Vocational Trade Schoolsl May 24, 2012 lViews: 214

High-performance liquid chromatography (HPLC) courses introduce students to a wide range of new tools and accessories, including tubing, valves and flanges. Here is an overview of some of the stuff

By: Rima Hammoudil Reference & Education > Vocational Trade Schoolsl May 24, 2012 lViews: 205

Discuss this Article

comments powered by Disqus