Even if it goes unnoticed, the pharmaceutical industry touches people’s lives on a very large scale every day. You, your friends, family members, and many people you don’t know have taken medication and/or been vaccinated at some point in your life. This means that you and other people get to know the pharmaceutical industry… So what exactly is the pharmaceutical industry?
Pharmaceutical industry can be defined as the sum of the processes of discovering, developing, producing and marketing drugs or pharmaceuticals against diseases. It can also be said as the method of patenting, testing, safety, effectiveness and marketing of drugs using drug testing.
The Beginning of the Pharmaceutical Industry
The pharmaceutical industry, as we understand it today, really has its origins in the second half of the 19th century. But the earliest records of the origins of medicinal formulas belong to the early Chinese, Hindu and Mediterranean civilizations. From the mid-1800s, the discovery, manufacture, and distribution of botanical medicines such as morphine and quinine took place through local pharmacies.
The scientific revolution of the 17th century propagated the ideas of rationalism and experimentation, and the industrial revolution of the late 18th century transformed commodity production. Combining these two concepts for the benefit of human health was a relatively late development, but these developments gave rise to the modern pharmaceutical industry.
The discovery of a truly scientific drug begins between 1803 and 1805, when Friedrich Sertürner, a German assistant pharmacist, produced morphine, an analgesic and sleep-inducing substance, from opium.
And since then, the modern pharmaceutical industry continues to develop, discover, develop, manufacture and market new drugs.
Stages of the Pharmaceutical Industry
The journey of a drug from the laboratory to the general sale is a long process. This process consists of 4 stages as Research, Screening, Clinical Trials and Regulation.
Research
Research often begins when a problem arises and/or to improve something that has happened. Research using existing knowledge of natural or chemical products is often concerned with fighting a disease more effectively or increasing the effectiveness of an existing drug.
Screening
Prior to the clinical stages, laboratory studies of chemical compounds involve screening 5,000 to 10,000 different compounds after the medical problem has been isolated and can take several years, depending on the drug.
After screening is complete, preclinical trials of approximately 250 compounds are conducted. Of these, about five compounds with the highest activity are selected and these are the most suitable chemical products for development.
Clinical Trials
Clinical trials usually involve a small group of healthy volunteers.
Stage 1 determines the safety of the dose and allows researchers to have a good idea of exactly how the drug works.
Stage 2 is to analyze the effectiveness of the drug and normally has a maximum of 200 participants.
Stage 3 typically involves a meta-study in several locations or countries, with a much larger number of participants comparing a drug to existing treatments at this stage. Stages 2 and 3 can last several months or years.
Stage 4 focuses on the length of time a drug must be used with the side effect it causes and therefore normally takes about two years. If there are no problems, the drug will go to the licensing phase.
Regulation
Every country demands that any new drug be tested before it hits the market. And each country usually has a department tasked with analyzing the drug’s efficacy and safety. Because it is often difficult to weigh the potential benefits and drawbacks of a drug, the seriousness of the biological problem and current public opinion often play an important role in dictating it. At this stage, recommended doses and administration methods (oral or other) are also reviewed. It usually takes 10-15 years for a drug to go from discovery to market.
Pharmaceutical Industry Trends
Pharmacovigilance: Produced drugs and vaccines cause different side effects. Pharmacovigilance will have a very important place in the pharmaceutical industry in order to follow up, evaluate and take precautions for adverse situations caused by side effects.
Personalized Medicine: Personalized medicine, which can also be expressed as precision medicine, will be a frequently encountered and heard concept in the coming years. In order to take quick action for personalized treatments, the need for small pharmaceutical facilities capable of rapid production will increase.