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The Food and Drug Administration 's (FDA) New Drug Application ( NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. [1] [2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding ...
Bioequivalence. Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. One article defined bioequivalence by stating that ...
Common brand names include: Brand name Countries Acamol Kenya, Chile, Israel Ace Bangladesh, Kenya Acet Philippines, Canada, Singapore Acetalgin
An aggregate of 06 in the WASSCE results is currently the acceptable cut-off point. Also, a year top-up program was rolled out in the 2017/18 academic year for practicing pharmacists with the B.Pharm(Bachelor of Pharmacy) qualification to obtain the Pharm.D qualification which will soon become the minimum degree for licensure.
Validation (drug manufacture) The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products ...
In March 2020, Novo volunteers started testing samples for SARS-CoV-2 with RT-qPCR equipment in the ongoing coronavirus pandemic to increase available test capacity. In June, the business announced it would acquire AstraZeneca 's spin-off Corvidia Therapeutics for an initial sum of $725 million (up to a performance-related maximum of $2.1 ...
Pharmaceutical code. Pharmaceutical codes are used in medical classification to uniquely identify medication. They may uniquely identify an active ingredient, drug system (including inactive ingredients and time-release agents) in general, or a specific pharmaceutical product from a specific manufacturer.
Critical Test Results Management (CTRM) also known as Critical Test Results Reporting, and Closed-Loop Reporting, is the software that handles a medical test result that has come back as critical to a patient’s health. CTRM software prevents the critical result from being lost in communication failures, improves patient safety, and documents ...