WebA: An amount of drug or chemical in units of mass such as milligrams. Special attributes of the amount are indicated by subscripts: A 0, the amount of drug in the body at “zero-time;” A B, the amount of drug in the body; A U, the amount of drug recovered in the urine, etc.The amount of drug in the drug’s volume of distribution is equal to the concentration of the …
A Glossary of Terms Used in the Biotherapeutic Industry
WebA term that encompasses both biotech and pharmaceutical companies. biosimilar A biopharmaceutical that is produced using a different cell line or master cell bank or different process, yet meets criteria for comparability in clinical activity. A biosimilar may differ in its purity/impurity profile, and its potency may differ in a definable way. WebGlossary. acceptable quality limit (AQL) The “quality level that is the worst tolerable” according to ISO 2859-1. It represents the maximum number of defective units, beyond which a batch is rejected. Suppliers can set different AQLs for critical, major and minor defects. ... active pharmaceutical ingredient master file (APIMF) procedure. circus babys babys
Guidance for Industry - Food and Drug Administration
WebThis guide to the biopharmaceutical lexicon provides definitions for common biopharmaceutical terminology and techniques. The lexicon is published with the February issue of BioPharm International Magazine. To download a pdf of the 2024 version, click "Download pdf". To receive a free printed copy of the 2024 edition, click on the "Send by ... WebBarrier. A physical partition that affords aseptic processing area (ISO 5) protection by partially separating it from the surrounding area. [Guidance for Industry: Sterile Drug … WebApr 12, 2024 · The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases. Paperless validation is applicable to every type of validation in biotech: cleaning, process, equipment, facilities, utilities, and many others. Twenty percent of a project’s budget is devoted to validation activities, so … diamond lake apartments okc