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Preclinical Development: Overview01:28

Preclinical Development: Overview

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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...
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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...
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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...
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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...
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In Vitro Drug Release Testing: Overview, Development and Validation01:10

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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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Drug Regulation01:25

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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...
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薬物開発

Juliana de Oliveira Alves1, Marcelo Henrique Quaresma Castro Salomão2

  • 1Universidade Feevale, Novo Hamburgo, Rio Grande do Sul, Brazil.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
PubMed
まとめ
この要約は機械生成です。

認知症の行動・心理症状（BPSD）の管理には、個別化された薬理学的戦略が必要です。この分析では、リスクを最小限に抑えるために、最も効果的な用量と最も短い期間を重視して、BPSDの薬をレビューします。

キーワード:
薬物療法認知症BPSD興奮攻撃性

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科学分野:

  • 神経学; 精神医学; 薬理学

背景:

  • 認知症は世界中で4700万人に影響を与えており、認知症の行動・心理症状（BPSD）は患者と介護者の生活の質に著しく影響を与えます。; BPSDは、興奮、攻撃性、妄想、幻覚を含み、効果的な管理戦略が必要です。

研究 の 目的:

  • 認知症患者におけるBPSDの薬理学的管理戦略を分析および比較すること。; 薬物療法の選択肢とその関連リスクおよび便益の概要を提供すること。

主な方法:

  • Medlineデータベースからの3つの科学論文の比較分析。; 認知症関連の行動症状に対する薬理学的治療に焦点を当てる。

主要な成果:

  • 定型および非定型抗精神病薬は、興奮や精神病に一般的ですが、死亡率の増加や脳血管イベントのリスクを伴います。; SSRI、アセチルコリンエステラーゼ阻害薬、メマンチン、鎮痛薬、抗けいれん薬は、様々な有効性と副作用プロファイルを示します。; ハロペリドールは、副作用リスクが高いため緊急時に使用されます。リスペリドン、アリピプラゾール、クエチアピンは、特定の適応症を持つ代替薬を提供します。

結論:

  • 患者の症状、併存疾患、虚弱性を考慮した個別化された薬理学的管理が重要です。; 有害事象を軽減するために、薬剤は最も効果的な用量で最も短い期間使用する必要があります。