皮肤病学中的生物类似药:识别神话和知识差距
Palak V Patel1, Caitlin G Purvis, Ramiz N Hamid
1Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
Dermatology online journal
|August 17, 2023
概括
生物类似药物的监管批准正在增加. 生物相似性指数可以标准化临床前定义,增强对这些药物的信任和透明度.
科学领域:
- 药理动力学和生物相似性评估.
背景情况:
- 生物类似药在美国接近监管批准,需要与创新生物制剂具有结构和功能相似性.
- 生物体表现出固有的批量对批量变化,使得即使是创新者也无法进行精确的重复.
研究的目的:
- 提出生物相似性指数,以标准化生物相似性的临床前定义.
- 通过量化,标准化的方法提高对生物类似药物评估的信任和透明度.
主要方法:
- 审查当前的生物相似性评估标准.
- 国际牛皮病理事会提出生物相似性指数的建议.
- 强调临床前分析和批准后监测.
主要成果:
- 生物相似性指数与批准后监测相结合,可以提供生物相似性的透明,定量定义.
- 这种方法可以增加对生物类似药物的信心,而不会增加成本.
结论:
- 制造商应优先考虑强大的临床前分析,以获得生物类似药物的批准.
- 皮肤科医生可能需要更多地关注临床证据以及临床证据的临床前数据.
- 生物类药物往往比创新产品批量具有更大的相似性,这表明一致的标准至关重要.
更多相关视频
11:07Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging
Published on: November 24, 2021
2.9K
07:25In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
17.8K
相关概念视频
Bioequivalence: Overview
1.1K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.1K
Biopharmaceutics and Pharmacokinetics: Overview
2.1K
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
2.1K
Confocal Fluorescence Microscopy
13.4K
Confocal microscopy is an advanced microscopic technique. The prime advantage of the confocal microscope over other microscopy techniques is its ability to block the out-of-focus light from the illuminated samples using pinholes. It is widely used with fluorescence optics to obtain high-resolution, sharp contrast images. Unlike optical microscopes, confocal microscopes use a focused beam of light laser to scan the entire sample surface at different z-planes. These microscopes are, therefore,...
13.4K
Structure-Activity Relationships and Drug Design
768
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
768
Clinical Applications of Epidermal Stem Cells
2.7K
Epidermal stem cells (EpiSCs) are mainly located at the basal layer of the epidermis. These cells repair minor injuries of the skin and replace dead skin cells. However, EpiSCs’ cannot heal severe wounds such as major burns or those from diabetes or hereditary disorders. In such cases, culturing the epidermal stem cells from the patient is possible and has yielded successful treatment options, such as laboratory-grown skin grafts. These grafts are synthesized using a patient’s own...
2.7K
