语言模型如何帮助药品制造偏差和调查?
Hossein Salami1, Brandye Smith-Goettler2, Vijay Yadav2
1Digital Services, MMD, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, NJ 07065, USA.
International journal of pharmaceutics
|December 19, 2024
概括
大型语言模型 (LLM) 通过从偏差报告中提取知识并识别类似事件,在制药生产中显示出前景. 人工智能工具可以提高效率和合规性,尽管需要进一步的研究.
科学领域:
- 人工智能的人工智能
- 制药制造业 制药制造业 制药制造业
- 自然语言处理自然语言处理.
背景情况:
- 大型语言模型 (LLM) 在各种自然语言处理任务中表现强.
- 为特定领域的应用,特别是制药制造业,利用LLM是一个公开的挑战.
- 历史制造偏差记录通常是无结构的和未充分利用的.
研究的目的:
- 调查生成LLM和文本嵌入模型对分析制药制造偏差的实用性.
- 评估AI在提高制药制造业生产率,效率,质量和合规性方面的潜力.
- 探索自动化知识提取和偏差报告的相似性分析.
主要方法:
- 构建一个行业相关的药品制造偏差数据集.
- 从偏差报告中自动提取知识的生成LLM (例如GPT,Claude) 的评估.
- 评估使用矢量空间分析识别类似历史事件的文本嵌入模型.
主要成果:
- 生成型LLM实现了高度精确的实体提取,更大的模型显示出卓越的性能.
- 在观察到的幻觉行为之外,LLM表现出强大的推理能力.
- 嵌入模型在捕捉特定偏差类别内的语义相似性方面表现出有效性.
结论:
- 人工智能驱动的工具,特别是LLM,在提高制药制造工作流程方面具有重大潜力.
- 对偏差报告的自动分析可以改善案例管理,并降低新制造活动的风险.
- 进一步的研究是必要的,以解决LLM应用的细微差别,并优化AI在这个领域的整合.
相关概念视频
01:19Pharmacovigilance
773
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
773
01:12Analysis of Population Pharmacokinetic Data
224
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
224
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
114
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
114
01:25Drug Regulation
1.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.3K
01:20Pharmacokinetic Models: Overview
578
Pharmacokinetic models utilize mathematical analysis to achieve a detailed quantitative understanding of a drug's life cycle within the body. They are instrumental in simulating a drug's pharmacokinetic parameters, predicting drug concentrations over time, optimizing dosage regimens, linking concentrations with pharmacologic activity, and estimating potential toxicity.
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
578
01:26Drug Administration and Therapy Phases: Overview
407
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
407