Greater Certainty in Drug Development

Certara Presents: A Two-Part Webinar Series on the Changing Regulatory Landscape in the EU.&nbsp; Stay ahead of the curve with this exclusive two-part webinar series designed for regulatory affairs professionals, compliance officers, and industry leaders navigating the ever-evolving landscape of EU regulations. Don’t miss this opportunity to gain critical knowledge and strategies to ensure your &hellip; <a href="https://www.certara.com/webinar/joint-advice-on-fda-ema-compliance-aligning-with-evolving-eu-regulations/">Continued</a>

The bioequivalence (BE) test is a test in which the manufacturer compares the bioavailability of other same-component drugs, and if certain criteria are met, it is judged that &#8220;biologically equivalent&#8221; or &#8220;the drug effect is equal&#8221;. If a drug is biologically equivalent and therapeutic equivalent, it can be replaced by one another if the clinical &hellip; <a href="https://www.certara.com/webinar/ivivc-toolkit-how-to-optimize-drug-formulation-korean-webinar/">Continued</a>

Model Informed Drug Development (MIDD) is a critical component in the drug development process and regulatory review. It is frequently utilized as part of a Clinical Pharmacology strategy to inform clinical trial design, including dose selection. Physiologically Based Pharmacokinetic (PBPK) modeling, a well-established element of MIDD, has traditionally been employed to assess drug-drug interactions (DDIs), &hellip; <a href="https://www.certara.com/webinar/physiologically-based-pharmacokinetic-pbpk-applications-in-model-informed-drug-development-midd-do-you-know-the-current-landscape-of-regulatory-acceptance/">Continued</a>

In a long-awaited development, Italy’s Medicines Agency, AIFA, underwent transformative changes on January 30th, 2024. Following the appointment of President Giovanni Nisticò, these have become fully operational.    This has been a recurrent topic of discussion, with talks of merging the Scientific Technical Advisory Committee (CTS) and the Price and Reimbursement Committee (CPR). However, the COVID-19 … Continued

Since its inception in 1997, the Clinical Data Interchange Standards Consortium (CDISC) has developed and supported globally adopted data standards to improve clinical trial efficiency. Clinical data standards are now recognized as playing a vital role in the entire end-to-end clinical trial process. Standardization allows for faster, better quality and less costly drug discovery.  One … Continued

Over the last decade, our industry has become familiar with Clinical Data Interchange Standards Consortium (CDISC) standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SEND, SDTM, and ADaM.  This blog shines a spotlight on the lesser-known Operational Data Model … Continued