Jove
Visualize
联系我们
JoVE
x logofacebook logolinkedin logoyoutube logo
关于 JoVE
概览领导团队博客JoVE 帮助中心
作者
出版流程编辑委员会范围与政策同行评审常见问题投稿
图书馆员
用户评价订阅访问资源图书馆顾问委员会常见问题
研究
JoVE JournalMethods CollectionsJoVE Encyclopedia of Experiments存档
教育
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab Manual教师资源中心教师网站
使用条款与条件
隐私政策
政策

相关概念视频

Preclinical Development: Overview01:28

Preclinical Development: Overview

4.4K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.4K
Clinical Trials: Overview01:11

Clinical Trials: Overview

2.9K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.9K
Drug Discovery: Overview01:26

Drug Discovery: Overview

7.8K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
7.8K
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

133
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...
133
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

452
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...
452
Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

2.0K
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...
2.0K

您也可能阅读

相关文章

通过共同作者、期刊和引用图与本文相关的文章。

排序
Same author

High-dose modified-release formulation of a poorly soluble drug via twin-screw melt coating and granulation.

International journal of pharmaceutics·2024
Same author

Industry Perspective - What does Industry Need to Accelerate Drug Product and Process Development?

Pharmaceutical research·2023
Same author

Multi-layer Raman chemical mapping to investigate the effect of API particle size and blending shear rate on API domain sizes in pharmaceutical tablets.

International journal of pharmaceutics·2022
Same author

Integrating sensors for monitoring blend content in a pharmaceutical continuous manufacturing plant.

International journal of pharmaceutics·2021
Same author

Prediction of tablet weight variability in continuous manufacturing.

International journal of pharmaceutics·2019
Same author

Mixing Cell: a Device to Mimic Extent of Lubrication and Shear in Continuous Tubular Blenders.

AAPS PharmSciTech·2019

相关实验视频

Updated: Jun 27, 2025

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
05:45

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

Published on: April 7, 2023

3.3K

加快过程开发和产品配方.

Mauricio Futran1, Fernando Muzzio2, Bikash Chatterjee3

  • 1Pharmaceutical Engineering Solutions, LLC, Westfield, NJ, USA. mfutran@gmail.com.

Pharmaceutical research
|May 2, 2024
PubMed
概括

新技术和适应性开发可以加快药物批准时间表,改善患者获得药物和紧急治疗的机会. 合作和监管转变对于更快的药物开发至关重要.

科学领域:

  • 制药科学 制药科学
  • 药物开发 药物开发
  • 监管科学 监管科学

背景情况:

  • 长时间的药物开发和批准过程推迟了患者获得新药的机会.
  • 对公共卫生紧急情况的反应时间缓慢,需要新的治疗方法.
  • 目前的药物配方和工艺开发面临着巨大的加速障碍.

研究的目的:

  • 探索加速药物产品开发和批准时间表的机会.
  • 识别阻碍更快药物开发的障碍,并提出解决方案.
  • 通过使用新技术,分享克服发展障碍的观点.

主要方法:

  • 分析了2023年1月NIPTE路径研讨会的讨论.
  • 审查当前的产品配方和工艺开发.
  • 识别先进的制造技术和适应性开发策略.

主要成果:

  • 新技术为加速药物开发提供了潜在的解决方案.
  • 先进制造和适应性开发是加速发展的关键策略.
  • 监管过程中的范式转变是必要的.

结论:

关键词:
尼普特 (Nipte) 是一个小岛屿.适应性发展是适应性的发展.先进的制造业制造业的制造业.连续制造 连续制造预测建模预测建模

更多相关视频

Research and Development of High-performance Explosives
10:33

Research and Development of High-performance Explosives

Published on: February 20, 2016

17.6K
Methods Development for Blood Borne Macrophage Carriage of Nanoformulated Antiretroviral Drugs
18:46

Methods Development for Blood Borne Macrophage Carriage of Nanoformulated Antiretroviral Drugs

Published on: December 9, 2010

13.3K

相关实验视频

Last Updated: Jun 27, 2025

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
05:45

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

Published on: April 7, 2023

3.3K
Research and Development of High-performance Explosives
10:33

Research and Development of High-performance Explosives

Published on: February 20, 2016

17.6K
Methods Development for Blood Borne Macrophage Carriage of Nanoformulated Antiretroviral Drugs
18:46

Methods Development for Blood Borne Macrophage Carriage of Nanoformulated Antiretroviral Drugs

Published on: December 9, 2010

13.3K
  • 加快药物开发需要技术创新和适应性战略.
  • 监管机构,行业和学术界之间加强竞争前的合作是必不可少的.
  • 需要一个共同的战略来克服药物开发和批准的障碍.