NIPER JEE case studies
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NIPER JEE is the entrance examination used for admission to postgraduate pharmaceutical programmes at the National Institute of Pharmaceutical Education and Research (NIPER) S.A.S. Nagar, Mohali, Punjab. The NIPER JEE case studies are 5 cases and about 3,450 words.
1Biosimilar Anti-HER2 Antibody with Out-of-Range Afucosylation
A manufacturer is developing a biosimilar of a marketed anti-HER2 monoclonal antibody. The candidate BS-1 matches the reference product on amino acid sequence, peptide mapping, intact mass, charge variants and C1q binding.
683 words, about 3 min2Failed Analytical Method Transfer for a Fixed-Dose Combination Tablet
A validated reversed-phase HPLC assay for a fixed-dose tablet containing metformin 500 mg and sitagliptin 50 mg is being transferred from a development laboratory to a contract QC laboratory. The method specifies a C18 column (150 × 4.6 mm, 5 µm), phosphate buffer at pH 3.0, and 20 minutes of shaking for sample extraction.
725 words, about 4 min3Scale-Up Dissolution Failure of a BCS Class II Weak Base Tablet
A 100 mg immediate-release tablet of a BCS class II weak base (pKa 6.4, logP 4.1, solubility 0.03 mg/mL at pH 6.8 and 9 mg/mL at pH 1.2) has been scaled from 20 kg to 300 kg. Composition: API 40%, microcrystalline cellulose 33%, lactose monohydrate 18%, croscarmellose sodium 5%, colloidal silicon dioxide 0.5%, magnesium stearate 1.0%.
741 words, about 4 min4Phenytoin Dosing in Hypoalbuminaemia, Renal Impairment and Valproate Co-therapy
A 54-year-old man with focal epilepsy, seizure-free for three years on phenytoin 300 mg once daily, is admitted with community-acquired pneumonia and acute-on-chronic kidney disease. Serum creatinine is 2.9 mg/dL (baseline 1.3), eGFR 25 mL/min/1.73 m², albumin 2.0 g/dL, bilirubin normal, INR 1.1.
623 words, about 3 min5Interim Analysis, Differential Loss to Follow-Up and a Composite Endpoint
An investigator-initiated multicentre open-label trial randomises 240 adults with sepsis-associated acute kidney injury to drug X plus standard care or standard care alone. The primary endpoint is a composite of death or initiation of renal replacement therapy at day 28.
678 words, about 3 min