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