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Out of Trend (OOT)
OOT represents a result that, while within the specification limits, shows an unexpected trend or deviation compared to historical data ...
Biologic Drugs
Biologic drugs are derived from living organisms or contain components of living organisms. This category includes vaccines, blood components, gene ...
Biosimilar Drugs
Biosimilars are highly similar to an already approved reference biologic, with no clinically meaningful differences in terms of safety, purity, ...
Pharmacogenomics
Pharmacogenomics is an advance field of pharmacy practice, which help to develop personalized medicine for a patient. Pharmacogenomics combines the ...
Regulatory Authorities
Regulatory authorities enforce legal frameworks for new drug products or medical devices approval in market. For example, US FDA oversees ...
Impurities
Impurities refer to unwanted substances or contaminants present in API or drug product. It can arise during manufacturing, handling, or ...
Innovator Drug
Innovator drug is a first time developed drug product through extensive research and clinical trials to demonstrate safety and efficacy. ...
Misbranded
A misbranded drug is a pharmaceutical product that has misleading information or false labeling or illegal advertising and violating regulatory ...
Over-the-Counter (OTC) Drug
OTC drugs are medications that can be purchased without a prescription for the treatment of minor ailments and conditions. As ...