Blog
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Orange Book
The Orange Book contains Approved Drug Products With Therapeutic Equivalence Evaluations, identifies drug products approved on the basis of safety ...
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Drug Discovery
Drug discovery is the process by which new candidate medications are discovered and involves a comprehensive scientific and research-based approach ...
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Generic Drug
Generic drugs are similar to brand-name drugs (RLD/RS). They have the same active ingredients and similar efficacy. The regulatory body ...
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Dose and Dosage
A dose is the amount of medicine you take at one time. Where dosage is about the schedule. When and ...
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Data Integrity
Data integrity in pharma industry refers to the completeness, consistency, and accuracy of data. Where complete, consistent, and accurate data ...
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Dossier
It is a set of documents which contains technical information about the drug product. The information includes administrative, quality, non-clinical ...
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Computerized System Validation (CSV)
Computer system validation (CSV) is the process of documenting that a computer system meets a set of defined system requirements. ...
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Controlled Substance
Controlled substances are drugs that have rules about how they are used. They can help when someone is sick. But ...
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Compounding
Compounding is generally a practice in which a licensed pharmacist or a pharmacy technician under the supervision of a licensed ...
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Clinical Trial
Clinical trials involve the participation of volunteers who are subjected to specific health interventions under controlled conditions to study the ...