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2. Biologics license application - Wikipedia

   en.wikipedia.org/wiki/Biologics_License_Application

   If the Form 356h is missing information, the FDA will reply within 74 days. [3] A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number. Statutory standards for BLA approval are largely the same as those for New Drug Application approval

3. New Drug Application - Wikipedia

   en.wikipedia.org/wiki/New_Drug_Application

   To legally test the drug on human subjects in the United States, the maker must first obtain an Investigational New Drug (IND) designation from FDA. [5] This application is based on nonclinical data, typically from a combination of in vivo and in vitro laboratory safety studies, that shows the drug is safe enough to test in humans. [5]

4. Drug test - Wikipedia

   en.wikipedia.org/wiki/Drug_test

   Drug-testing a blood sample measures whether or not a drug or a metabolite is in the body at a particular time. These types of tests are considered to be the most accurate way of telling if a person is intoxicated. Blood drug tests are not used very often because they need specialized equipment and medically trained administrators.

5. Marketing authorisation - Wikipedia

   en.wikipedia.org/wiki/Marketing_authorisation

   In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.

6. Investigational New Drug - Wikipedia

   en.wikipedia.org/wiki/Investigational_new_drug

   The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

7. Enzyme multiplied immunoassay technique - Wikipedia

   en.wikipedia.org/wiki/Enzyme_multiplied...

   The more drug there is in the sample, the more free enzyme there will be, and the increased enzyme activity causes a change in color. [ 2 ] : 70 Determination of drug levels in serum is particularly important when the difference in the concentrations needed to produce a therapeutic effect and adverse side reactions (the therapeutic window ) is ...

8. AOL Mail

   mail.aol.com

   Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!

9. Drug Master File - Wikipedia

   en.wikipedia.org/wiki/Drug_Master_File

   Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form.It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.