Anatomical Therapeutic Chemical (ATC) classification system Structure In the Anatomical Therapeutic Chemical (ATC) classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. Drugs […]
Key Definitions & Adverse Drug Reactions Classification Adverse drug reaction (ADR)—The World Health Organization defines an ADR as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, […]
The WHO Programme for International Drug Monitoring Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The aims of PV are to enhance […]
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 […]
Adenylyl cyclase: cAMP pathway Activation of AC results in intracellular accumulation of second messenger cAM P (Fig. 4.6) which functions mainly through cAMP-dependent protein kinase (PKA). The PKA phosphorylates and alters the functi on of many enzymes, ion channels, transporters. […]
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 […]