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LSQ and DSM Biologics Australian Road Show ADELAIDE Event Details: Date: Adelaide Monday 16th April 2012 Venue: PwC Adelaide Office LV 14, 91 King William St Adelaide, SA 5000 Time: Australia 11:30am
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What is lsq and dsm biologics?
LSQ stands for Letter of Support Qualification and DSM Biologics stands for Drug Substance Master File Biologics. LSQ is a document submitted by an applicant seeking FDA approval of a generic drug. DSM Biologics is a regulatory document that provides detailed information about the manufacturing process and controls for the drug substance in biologics.
Who is required to file lsq and dsm biologics?
Manufacturers and applicants of generic drugs are required to file LSQ, while manufacturers of biologics are required to file DSM Biologics.
How to fill out lsq and dsm biologics?
LSQ and DSM Biologics must be filled out according to the specific guidelines and instructions provided by the FDA. The documents must contain accurate and detailed information about the drug product or substance.
What is the purpose of lsq and dsm biologics?
The purpose of LSQ is to demonstrate the equivalence of a generic drug to its reference listed drug, while the purpose of DSM Biologics is to provide detailed information about the manufacturing process and controls for the drug substance in biologics.
What information must be reported on lsq and dsm biologics?
LSQ must include information on the formulation, labeling, and bioequivalence of the generic drug, while DSM Biologics must include information on the manufacturing process, quality control, and stability of the biologic drug substance.
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