Glossary
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February 27, 2012
Intra-company collections of policies, systems and programs to protect the aforementioned environment, assure worker safety and exhibit responsible behavior.…
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February 27, 2012
A marketing application usually reserved for antibiotics that duplicate products that were previously approved under a full marketing application. Similar to an ANDA.…
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February 27, 2012
A company that offers both contract drug development and manufacturing services. Comprehensive services range from early-stage R&D services such as synthesis, scale-up, formulation development, stability studies and method development all the way thr…
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February 27, 2012
The utilization of biopharmaceutical principle to determine the physicochemical properties of a drug substance. Through the process of choosing the substance's best form, evaluating its physical properties and understanding its stability under variou…
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February 27, 2012
A formal request made by potential contract clients for information regarding the capabilities of a contract manufacturer. Used as a preliminary screen for potential contractors. Is more general in nature and does not include a request for a price of…
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February 27, 2012
Batches which are manufactured prior to full scale cGMP batches. Used to fine-tune processes before committing to full scale manufacture.…
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February 27, 2012
An apparatus used to freeze dry or lyophilize products. Units are capable of freezing products, applying a vacuum and removing water by sublimation.…
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February 27, 2012
An electronic document that enables a single view of the product and order and is used for drug authentication. The pedigree goes with the drug and tracks the change of custody as the drug passes through the supply chain.…
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February 27, 2012
A medication used to treat fungal infections such as athlete's foot, ringworm, candidiasis (thrush), serious systemic infections such as cryptococcal meningitis, and others.…
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February 27, 2012
A new drug application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has…
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February 27, 2012
An exploratory clinical study to gain a better understanding of drug parameters.…
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