Category: ホワイトペーパー
How Modeling & Simulation is Addressing the Immunogenicity Challenge: An academic nicety is now a drug development and regulatory differentiator
Learn how modeling and simulation can help drug developers overcome the immunogenicity challenge, a major hurdle for biologics development and regulatory approval.
How Drug Developers can Navigate the Inflation Reduction Act of 2022
Learn how the IRA will impact how new drugs are marketed and why negotiating pricing while preparing for lower reimbursements can be challenging for pharmaceutical companies.
Drug interactions with therapeutic proteins, regulatory expectations and modeling and simulation approaches
The eCTD Submission Process: Tips and Tricks for Drug Development Success
欧州における希少疾病治療へのアクセスを促進する
Axendia: コストではなく価値に報いることで医療成果を改善
希少疾患治療薬開発の課題と機会
This whitepaper reflects on some of these challenges and opportunities in rare diseases drug development.
Innovations in Drug and Medical
Device Value Communications:
Optimizing Local Payer Engagement
医薬品開発候補化合物に対する信頼性の高いバイオマーカー戦略プランに不可欠な要素
This white paper will explain why the inclusion and assessment of biomarkers in drug development can also inform many decisions.