Tag: CMC

Managing Bioavailability Risks During IND/NDA Filings: A Practical Guide Pharmaceutical professionals are increasingly facing challenges in overcoming bioavailability risks when preparing for IND/NDA filings. Bioavailability is a crucial aspect of…

Strengthening Data Packages to Address Unexplained Dissolution Variability in Early Development Dissolution variability can be a significant hurdle during the early stages of pharmaceutical formulation development. When dissolution rates differ…

Addressing Early Development Bioavailability Risks Through a Data Package Enhancement Playbook In the competitive landscape of pharmaceutical research and drug development, bioavailability risk flagged during early development stages poses substantial…

Managing Late Identification of Excipient Incompatibility During Regulatory Review In the intricate landscape of pharmaceutical manufacturing and quality assurance, the late identification of excipient incompatibility can pose significant risks to…

Addressing Missing QbD Elements in Regulatory Reviews for Formulation Data The formulation development phase is critical in ensuring the quality and efficacy of pharmaceutical products. However, missing Quality by Design…

Dissolution Variability During Tech Transfer: A Practical Guide to Reformulating Strategies Dissolution variability can be a critical issue during the tech transfer of pharmaceutical products, particularly affecting bioavailability, product quality,…

Managing Scalability Risks in Prototype Scale-Up Preparations Scaling up a prototype during the formulation development process can expose critical vulnerabilities that impact product quality and compliance with regulatory requirements. Inconsistent…

Strengthening Data Packages for Scale-Up: Addressing Non-Scalable Prototypes In the complex world of pharmaceutical manufacturing, encountering a prototype that is not scalable during scale-up preparation poses significant challenges. As a…

Addressing Unexplained Dissolution Variability During Scale-Up Preparation Dissolution variability during scale-up preparation presents a significant hurdle in pharmaceutical development, potentially leading to late-stage reformulation and delayed time-to-market. This playbook equips…

Mitigating Bioavailability Risks During IND/NDA Filings: An Actionable Playbook In the highly regulated world of pharmaceutical development, bioavailability risks can jeopardize the success of drug applications such as Investigational New…

Addressing Bioavailability Risks During Tech Transfer: A Comprehensive Playbook Transferring processes between manufacturing sites or introducing new formulations presents inherent bioavailability risks that can affect product quality and patient outcomes.…

Addressing Late-Identified Excipient Incompatibilities During Regulatory Reviews In the dynamic landscape of pharmaceutical formulation development, identifying excipient incompatibilities late in the regulatory review process can pose significant risks to product…