Category: Lab Notes: Pharmaceutical Industry
ICH Q8
ICH Q8, titled “Pharmaceutical Development”, is a key guideline from the International Council for Harmonisation (ICH) that outlines a systematic…
ICH Q12
ICH Q12, titled “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”, is a guideline developed by the International Council…
Real-Time Release Testing
Real-Time Release Testing (RTRT) is a modern quality assurance approach in pharmaceutical manufacturing that enables the release of a drug…
ICH Q13
ICH Q13 is a guideline developed by the International Council for Harmonisation (ICH) to provide a harmonized framework for the…
Cell Cultivation Using WAVE Bioreactor
The WAVE Bioreactor is a single-use, rocking motion bioreactor system designed for the cultivation of suspension and some adherent cells…
European Medicines Agency (EMA)
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision,…
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) is a federal agency within the U.S. Department of Health and Human Services…
ALCOA Principles
The ALCOA principles are fundamental concepts used to ensure the integrity, reliability, and trustworthiness of data, particularly in regulated environments…
Pharmaceutical Quality System
A Pharmaceutical Quality System (PQS) is a comprehensive framework designed to ensure that pharmaceutical products are consistently produced and controlled…
ISO 9000 family
The ISO 9000 family is a set of international standards developed by the International Organization for Standardization (ISO) that provides…
Nephrotoxicity
Nephrotoxicity is a serious adverse effect characterized by damage to the kidneys, which can lead to acute kidney injury or…
Ototoxicity
Ototoxicity is a serious adverse effect that occurs when drugs or chemicals cause damage to the delicate structures of the…
Tetracycline Derivatives and Novel Drug Development
Tetracycline antibiotics, originally developed in the mid-20th century, have evolved significantly beyond their initial use as broad-spectrum antimicrobials. Structural modifications…
Tetracyclines in Autoimmune Diseases
Tetracyclines, long known for their antimicrobial properties, have emerged as promising therapeutic agents in the management of several autoimmune diseases. …
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Nonsteroidal anti-inflammatory drugs (NSAIDs) are a class of medications widely used to reduce inflammation, relieve pain, and lower fever. They…