Drug Development challenges and growth of Clinical trial Industry

drug development

Drug Development challenges and growth of Clinical trial Industry.

Drug development is an important step that consists and preclinical and clinical development. Preclinical includes toxicology and animal pharmacology studies. Once Preclinical is over, clinical phase starts with phase I, Phase II, Phase III studies and Phase IV studies.  The drug get marketing approval after Phase III studies are over.  The drug development under goes various kind  of challenges like in phase III study  how many patients to be involved, what should be the standard material, study design should be double blind or not, what is the duration of the treatment and what will be total treatment time. To plan and execute a study these points must be sorted out and planned it properly. The data point has its own challenges. These must be cleaned and checked before doing analysis.

Even though the challenges of are huge but the growth of Industry has taken a major step forward. Many Pharmaceutical companies and CRO are getting themselves involved in clinical research Industry. Various disease conditions both old and recent like COVID has forced them to innovate.  Covid has also caused them to innovate new drugs and therapies and many Pharmaceutical companies, Nutraceutical companies, Ayurvedic companies and food companies has come up with various products that can increase disease fighting ability and enhance body/s immunity. Pharmaceutical and Ayurvedic companies fight for diseases where as Nutraceutical companies look for new immunity booster for the body. That means these new products need to undergo drug development process. For pharmaceuticals, we need to do all Manufacturing, Quality control, Quality Assurance, preclinical, and clinical data as per regulations, GMP, GLP and GCP guidelines. On the other hand, the food companies who are focusing on producing immunity boosters they need to do Clinical trials of their food product, especially when product is having health claim.

Covid has increased in demand for pharmaceutical products and food products and so the opportunity in clinical research sector. There will be challenges in the drug development sector and there will be opportunity in the pharmaceuticals sector especially clinical research.

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