MedDRA or Medical Dictionary for Regulatory Activities A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus […]
International Classification of Diseases (ICD) ICD serves a broad range of uses globally and provides critical knowledge on the extent, causes and consequences of human disease and death worldwide via data that is reported and coded with the ICD. Clinical […]
Defined Daily Dose (DDD) Definition and introduction The basic definition of the defined daily dose (DDD) is: The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. The DDD is a unit […]
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 […]