USFDA
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A Review on the Regulatory Study for Implementation of Schedule-M Amendments in Pharmaceutical Industries in India
Abstract: A major regulatory change in pharmaceutical manufacturing industry in India is the introduction of the updated Schedule M (2023–2024). The aims to compliance the country's Good Manufacturing Practices (GMP) with international quality standards. The review evaluates the Schedule M amendments implementation strategies, industrial impact and regulatory relevance. Legislative texts, official notices, WHO GMP reports, ICH guidelines, guidance documents of CDSCO and peer-reviewed literature were all explored as part of the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 13, Issue 2, 2026 Read article
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Bioanalytical Method Development and Validation for the Estimation of Levothyroxine in Human K₃EDTA Plasma by Using UPLC-MS/MS
Abstract: A rapid, sensitive, and highly selective UPLC-MS/MS method was developed and validated for the quantitative estimation of Levothyroxine in human plasma using Levothyroxine-D₃ as the internal standard (IS). Chromatographic separation was achieved on a Gemini NX-C18 column (50 × 3.0 mm, 3 µm) with a mobile phase consisting of acetonitrile and water (70:30, v/v) containing 0.015% formic acid at a flow rate of 0.5 mL/min. The total run time was …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 3, 2025 · pp. 32–46 Read article
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Emerging Therapies for Diabetes Mellitus: Efficacy and Safety of USFDA-Approved Drugs and Late-Stage Clinical Trials
Abstract: This review provides a comprehensive analysis of drugs approved by the U.S. Food and Drug Administration (USFDA) for managing diabetes mellitus (DM) from 2013 to 2022, including emerging treatments from phase 3 clinical trials during this period. Over the past decade, the treatment landscape for diabetes has evolved significantly, with new therapies not only improving blood sugar control but also targeting broader health outcomes like heart and kidney health. In …
Published in International Journal of Toxins and Toxics · Vol. 2, Issue 2, 2025 · pp. 11–23 Read article