Rusan Pharma Ltd. - Dossiers Format 1478666213 & Dosage Formulation of Finished API Products
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WHO Expert Committee on Specifications for Pharmaceutical Preparations.
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of ...
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Although considered pharmacologically inert, pharmaceutical excipients have been shown to interact with active drug substances to affect the safety and efficacy of drug products.1 Therefore, there is an increasing awareness of the necessity to understanding interactions between excipients and the active pharmaceutical ingredient (API) in finished dosage forms. One of the areas of major concern ...
متن کاملHot-Stage Microscopy for Determination of API Particles in a Formulated Tablet
Although methods exist to readily determine the particle size distribution (PSD) of an active pharmaceutical ingredient (API) before its formulation into a final product, the primary challenge is to develop a method to determine the PSD of APIs in a finished tablet. To address the limitations of existing PSD methods, we used hot-stage microscopy to observe tablet disintegration during temperatu...
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The lack of commercially-available pediatric drug products and dosage forms is well-known. A group of clinicians and scientists with a common interest in pediatric drug development and medicines-use systems developed a practical framework for identifying a list of active pharmaceutical ingredients (APIs) with the greatest market potential for development to use in pediatric patients. Reliable a...
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` We have, in fact, plans in place for several API 4000 LC/ MS/MS systems,’ said Jim Hulse, senior vice president, bioanalytical, MDS Pharma Services. ` The capabilities of the API 4000 are of critical importance. More and more drugs with highly speci® c pharmacological activities and lower daily dosage recommendations are being developed through pharmaceutical pipelines. The lower the dosage r...
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