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Clinical Trials: Overview01:11

Clinical Trials: Overview

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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 Regulation01:25

Drug Regulation

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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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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

369
Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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High-throughput Quantitative Real-time RT-PCR Assay for Determining Expression Profiles of Types I and III Interferon Subtypes
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米国食品医薬品局 (Food and Drug Administration) の加速承認を受けた薬物の承認前および承認後の試験の特徴

Huseyin Naci1, Katelyn R Smalley1, Aaron S Kesselheim2

  • 1LSE Health, Department of Health Policy, London School of Economics and Political Science, London, England.

JAMA
|August 16, 2017
PubMed
まとめ

米国食品医薬品局 (FDA) は,2009年から2013年の間に22の薬剤に加速承認を与えた. 承認後の試験は多くの薬剤の有効性を確認したが,しばしば承認前の試験に似た代替措置に頼った.

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科学分野:

  • 医薬品開発と規制科学
  • 臨床試験の設計と方法論
  • 腫瘍学と重症疾患の治療薬

背景:

  • 加速された承認は 代替エンドポイントに基づいて 深刻な疾患の薬が患者に早く届くことを可能にします
  • 初期承認後の臨床効果を検証するために,確認試験が義務付けられています.
  • これらの試験の特徴は,加速承認経路の有効性を理解するために不可欠です.

研究 の 目的:

  • 薬剤の事前承認と確認臨床試験の特徴を分析する.
  • FDAが要求する承認後の試験の成果とタイミングを評価する.

主な方法:

  • 2009年から2013年にかけて承認された医薬品のFDA文書のレビュー
  • 予備承認および確認試験の設計,エンドポイント,および結果に関するデータの抽出
  • 規制決定の分析と要件を満たすまでの時間

主要な成果:

  • 2009年から2013年にかけて,22の薬剤が24の指標 (19のがん) のための加速承認を受けました.
  • 確認試験では,事前承認試験と同様の代替手段が用いられることが多く,42%が有効性を確認した.
  • 承認後の試験では,有意な遅延と効果の証明の失敗が認められ,5年以上経過した後に確認を待った8つの指標が示されました.

結論:

  • 薬剤の迅速承認の有効性は 承認から数年後に確認される.
  • 予備承認と確認試験は,代替措置への依存を含むデザインの類似性を共有しています.
  • 加速された承認経路は,実証された臨床的利益を確保するために,市場公開後の強力な監視を必要とします.