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Updated: Jun 9, 2026

Development of Inhibitors of Protein-protein Interactions through REPLACE: Application to the Design and Development Non-ATP Competitive CDK Inhibitors
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Development of Inhibitors of Protein-protein Interactions through REPLACE: Application to the Design and Development Non-ATP Competitive CDK Inhibitors

Published on: October 26, 2015

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开发一个分析质量通过设计RP-HPLC方法及其验证估计Gefitinib从散装,平板电脑剂量形式,和复杂的纳米配方

Mahesh P More1,2, Sagar R Pardeshi3, Rahul Tade4

  • 1Dr Rajendra Gode College of Pharmacy, Department of Pharmaceutics, Malkapur, Buldhana (M.S.) 443 101, India.

Journal of AOAC International
|April 22, 2024
PubMed
概括

这项研究开发了一种强大的RP-HPLC方法,使用设计质量 (QbD) 来估计gefitinib (GF),一种不溶解的抗癌药物. 这种创新方法确保了各种配方药物的准确量化,有助于制药发展.

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An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use10:33

An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use

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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...