Preformulation studies for sterile dosage forms as per US regulatory body
Preformulation involves the application of biopharmaceutical principles to the physicochemical parameters of drug substance are characterized with the goal of designing optimum drug delivery system . Preformulation commences when newly synthesized drug shows sufficient pharmacologic promise in animal model to warrant evaluate in manPreformulation is a learning phase about a drug
Preformulation studies have a significant part to play in anticipating formulation problems. The main goal of preformulation studies is Innovative, stable, safe,cost- effective dosage forms capable of delivering the substance for its intended use.
Key words : preformulation, biopharmaceutical., drug delivery.
Author link: http://www.pharmainfo.net/balakrishnatanikonda
Co author : http://www.pharmainfo.net/sathishkumar
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