2022-04-20
Societies all over the world are faced with various diseases. These diseases may be genetically encoded in our cells, or they may occur due to environmental factors that we may encounter at every moment of our lives. At the same time, many epidemics of endemic, epidemic and pandemic character have been experienced from the Ancient Age to the present, and millions of people have lost their lives in these epidemics. In order for societies to preserve their existence and maintain their lives well, the discovery of therapeutic drugs against diseases and the correct production of these discovered drugs and their timely delivery to the patient are very important.
R&D studies in the pharmaceutical industry are of great importance as they directly affect human health. Pharmaceutical R&D studies are more complex when compared to other sectors because they include human-participated clinical studies as well as basic research. In addition, the discovery of a small molecule compound or an antibody, protein, gene therapy or other biological drug is a costly process. According to studies, the process from the discovery of a new drug to the marketing phase takes 10 to 15 years.
Drug discovery is a multifaceted process involving the identification of a drug chemical that is therapeutically useful in the treatment of a disease and management of the treatment process. This process, which we can divide into three stages, consists of drug discovery, drug development studies and clinical research studies. At the beginning of this process, as a first step, potential targets are determined to interfere with the biological origin of the disease. By identifying a possible therapeutic target, its function and role in disease are revealed. An ideal target should be effective and meet clinical and commercial requirements. Most importantly, the drug developed in line with the target should be administered. In line with the techniques of molecular biology, biochemistry, biophysics and other disciplines, a pioneer product is created with the discovered drug chemical. The precursor must be specific and selective for the target receptor. It should also have a synthetically stable structure. The identified precursor product is optimized and the strength, size, shape, handling, toxicity and biological activity of the molecule are characterized if it shows a promising therapeutic effect against disease. After these studies, pharmaceutical formulation development studies are initiated and a stable and optimal dosage form with high bioavailability is produced. Preclinical studies, clinical studies and phase studies are carried out and the drug is approved by the relevant authorities and presented to the market as an 'Original Medicinal Product'.
Pharmaceutical R&D studies include generic medicinal product (equivalent drug) R&D studies as well as a new drug discovery. A medicinal product that has the same qualitative and quantitative composition and the same pharmaceutical form as the original medicinal product in terms of active substances and whose bioequivalence with the original medicinal product has been proven by appropriate bioavailability studies is defined as “Generic medicinal product (equivalent drug)”.
As CT Pharma Research, we offer Custom Tailored Solutions in all processes, from determining the molecule of generic drug R&D studies to preparing the CTD license file and applying to the Ministry of Health to obtain a drug license.
