Naseem A. Charoo
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View article: Risk-Based Approach for Defining Retest Dates for Active Pharmaceutical Ingredients and Excipients
Risk-Based Approach for Defining Retest Dates for Active Pharmaceutical Ingredients and Excipients Open
Drug substances and excipients must be stored in recommended storage conditions and should comply with their specifications during the retest period for their use in the manufacture of drug products. The ICH (International Council for Harm…
View article: Using Metabolite Data to Develop Patient Centric Specification for Amide Impurity in Vildagliptin Tablets
Using Metabolite Data to Develop Patient Centric Specification for Amide Impurity in Vildagliptin Tablets Open
Many specified impurities in vildagliptin’s finished product have been disclosed in the literature that are above their qualification threshold. We used the impurity B (amide impurity) as a case example to explore whether existing literatu…
View article: Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate Open
View article: Pharmaceutical product development: A quality by design approach
Pharmaceutical product development: A quality by design approach Open
The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug…
View article: Risk assessment for extending the Biopharmaceutics Classification System-based biowaiver of immediate release dosage forms of fluconazole in adults to the paediatric population
Risk assessment for extending the Biopharmaceutics Classification System-based biowaiver of immediate release dosage forms of fluconazole in adults to the paediatric population Open
Objectives The paediatric population undergoes developmental changes in gastric pH, gastric emptying, intestinal transit time, membrane permeability, protein binding, body water, distribution and metabolism. It is widely recognised that ch…
View article: Establishment of a BioequivalenceIndicating Dissolution Specification for Candesartan Cilexetil Tablets Using a Convolution Model
Establishment of a BioequivalenceIndicating Dissolution Specification for Candesartan Cilexetil Tablets Using a Convolution Model Open
The aim of the present work was to establish a bioequivalence-indicating dissolution specification for candesartan cilexetil tablets.The discriminating power of the selected medium (0.25% Polysorbate 20 in pH 6.5 phosphate buffer) was asse…