Medical research in India is still limited to some apex medical institutes and central laboratories to a large extent. India contributes a meagre 1.2% to the total published medical research, in nearly 6800 journals, worldwide. Moreover, approximately 70% of this research literature comes only from 10 medical colleges. The time is ripe enough to have more medical research centers which will focus on the diseases prevalent in our country for the benefit of mankind. Indian doctors see a large pool of patients in a day,but lack of proper inclination towards the medical research methodologies does not lead to any blockbuster outcome.
Continue reading Facilitation of Medical Research and Communication FMRC
Phases of Clinical development
Clinical research determines the safety and efficacy of medications, devices, diagnostic products and treatment regimens discovered for the human use in terms of prevention, treatment, diagnosis or for relieving symptoms of a disease. Successfulness of the pre-clinical research and approval from the regulatory authority are the mandatory requirements for the clinical trials. Clinical trials are divided in 4 phases from phase 1 to 4.
Pharmaceutical research plays an essential role in the development of new drug molecules for safe and effective use in patients. Preclinical and clinical research are two important phases in drug discovery and development process. It takes about 12 to 16 years to bring a molecule from laboratory to clinical practice. Based on the type of drug molecule,the duration of pre-clinical research varies from 2 to 6 years while clinical research takes approximately 7 to 12 years. Today the challenge with pharmaceutical research is to reduce the lead time of pre-clinical and clinical phases, which can be made possible by adopting newer technologies, using rational drug design process in place of traditional processes.
Continue reading Preclinical and clinical research: Part of drug development process – Part I
The concept of pharmacovigilance practice is normally not well understood, either by health professionals, patients or the general population. Development of guidelines and standards are required for a coherent and good pharmacovigilance system, which describe the practical details of the intended information ﬂow.
Good pharmacovigilance systems should have the capability for receiving and processing of reports with veriﬁcation, interpretation and case causality assessment. It should have databases and procedures for data analysis, review and signal detection.
Continue reading Good Pharmacovigilance System
According to WHO “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” In other words the goal of pharmacovigilance is getting the best outcome of therapy by patient care and surveillance. Good pharmacovigilance System will identify the risks and risk factors related to adverse drug reactions (ADRs) during the complete product life cycle. This information allows for intelligent, evidence-based prescription and has the potential for preventing ADRs.
Continue reading Understanding Pharmacovigilance System & Processes