PK/PD Drug and Disease Modeling and Simulation

Quantifying Drug, Disease, and Trial Information to Aid Efficient Drug Development

For almost 20 years, our pharmacometricians have combined insight and innovation to build quantitative models of the interactions between the human body, drug effects, and diseases. Our team develops models that are fit-for-purpose and meet strategic objectives, are aligned with regulatory authority requirements and expectations, and are updated and adjusted based on program evolution.

Here are some of the approaches that we have used to support hundreds of drug approvals in a range of therapeutic areas in recent years:

  • Drug models—PopPK, exposure-response models, concentration QT models, etc—describe the exposure-response relationship for both drug efficacy and safety
  • Disease progression models describe the relationship between biomarkers and clinical outcomes, time course of disease and placebo effects; we have particularly deep experience in tumor growth modeling and viral kinetic modeling
  • Trial models are used to determine the effect of inclusion/exclusion criteria, drug adherence, and protocol deviations on the probability of trial success

As a member of your development team, we leverage the wide range of Certara’s model-informed drug development (MIDD) capabilities to answer key technical, regulatory, and commercial challenges.

Pharmacometrics Strategy Aligned to Development Cycle and Regulatory Goals

適切に設計されたファーマコメトリクスに基づく申請戦略は複数の目標に対して適用されます。まず、ファーマコメトリクス戦略に基づいて、開発計画における要件の優先順位を決定し、いつどのようにそれらに対応するかについて詳細に定義します。次に、戦略的ロードマップを策定することで、確実に目的に沿った試験および解析の方向性を示し、開発計画に付加価値を与えます。最後に、頑健性の高い戦略を構築することで、規制当局・共同開発パートナー・利害関係者との良好な関係性を促進します。

前臨床

  • Support first-in-human (FIH) designs by bridging pre-clinical PK/PD data and predecessor compounds
  • 安全性および有効性評価を目的とした動物からヒトデータへのトランスレーション (橋渡し)
  • 心臓安全性リスクの評価
  • 曝露-安全性、曝露-応答、および曝露-活性の関係性を同定
  • PBPK モデルの活用により薬物間相互作用 (DDI) に関する見解を早期に提示
  • FIH 投与量選択の根拠を提示

第Ⅰ相試験から PoC 試験

  • Clinical pharmacology quantitative PK/PD evaluation
  • Support PoC designs by modeling the time-course of disease, the compound effect, and the effect of patient variables; evaluate PoC success criteria
  • Support strategies to evaluate Proof-of-Mechanism
  • Support conduct of clinical pharmacology programs through quantitative pharmacology services (data management, non-compartmental analysis, clinical study report contributions)
  • 薬物代謝に関するコンサルティング (薬物間および薬物-食物間相互作用の最適化など)

Proof-of-Concept through pre-NDA activities

  • 第Ⅰ相 PK/PD データおよび既存医薬品を組み合わせたブリッジングによる用量および投与レジメン選択の試験を支援
  • 適応症間のブリッジングに基づく新規適応症への展開を支援
  • 文献データを活用した包括的な安全性・有効性評価を通して、競合品に対する相対的な有効性および/または安全性を定義
  • Develop and implement strategic modeling and simulation plans that are integrated into the clinical development plan
  • Develop criteria for interim analysis—evaluate innovative designs
  • 薬物間相互作用などの安全性リスクを評価
  • 代替製剤を最適化
  • Comparison to competitor compounds—comparative effectiveness
  • 母集団薬物動態 (PK) および曝露-応答解析を目的とした試験デザイン
  • 規制当局との協議を支援

登録申請業務

  • 用量設定の根拠提示
  • 母集団 PK 解析
  • 曝露-応答解析
  • 規制当局の照会事項への対応を支援
  • 登録申請文書における、臨床薬理およびファーマコメトリクスに関連する項目の文書作成

市販後 (調査)

  • Comprehensive safety/efficacy evaluation, including comparison of double-blind and open-label trials
  • 情報の公開戦略を支援
  • HEOR modeling
  • Market access—value strategy

その他

  • Special populations—support pediatric and orphan drug trial designs
  • Special populations—hepatic and renal impairment, co-morbidities
  • Special populations—PK/PD bridging to Asian and other ethnic populations
  • IVIVC (In Vitro-In Vivo Correlation)
  • OTC 医薬品、ジェネリック医薬品
  • グローバルヘルス

Contact us to learn how we can provide you with a reliable, reproducible and predictable decision support system, inform and optimize your drug’s label, and understand all dimensions of your drug’s efficacy and safety profile.

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