HISTORY OF PHARMACOVIGILANCE Pharmacovigilance (PV) is defned by the European Commission (EU) as the “Process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefts of medicines”. The international PV systems […]
Therapeutic goods in the United States are regulated by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter at retail outlets and others by prescription only. Each of the controlled substances is identified under […]
Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for […]
A number of anatomical and physiological factors determine the pharmacokinetic profile of a drug. Differences in physiology in paediatric populations compared with adults can influence the concentration of drug within the plasma or tissue. Healthcare professionals need to be aware […]
Adverse drug reactions (ADRs) are an important and frequent cause of morbidity and mortality. ADR can be related to a variety of drugs, including anticonvulsants, anaesthetics, antibiotics, antiretroviral, anticancer, and antiarrhythmics, and can involve every organ or apparatus. The causes […]
During pregnancy, a large part of the body is affected by the physiological and anatomical changes that start in early pregnancy. Many of these changes significantly affect the pharmacokinetic (absorption, distribution, metabolism, and excretion) and pharmacodynamic properties of different drugs […]
Elderly patients are the main users of drugs and they difer from younger patients. They are a heterogeneous population that cannot be defned only by age but should rather be stratifed based on their frailty. The elderly have distinctive pharmacokinetic […]
CDSCO Introduction The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and […]
Pharmacovigilance in India Indian pharmaceutical industries are estimated to account for about 3.5% in value of the international pharmaceutical industry. By 2020, it is expected to grow to US$55 billion and US$100 billion by 2025, thus evolving as the sixth […]