In the pharmaceutical arena, post-marketing surveillance PMS) plays a fundamental role in monitoring adverse effects and ensuring public health. Additionally, owing to the current data-driven world our blog explores the application of Quantitative Structure-Activity Relationship (QSAR) in post-marketing safety surveillance, with a specific focus on the role of regulatory vendors.
In European Union's (EU) Clinical Trial Regulation (CTR) emerges as a transformative force, reshaping life sciences companies' approach and conduction of clinical trials. Clinical Trial Regulation aims to streamline and harmonize the regulatory processes governing clinical trials across EU member states. Its overarching goal is to enhance efficiency, ensure patient safety, and foster transparency in the realm of clinical research.
The rise of biopharmaceuticals has been nothing short of a revolution in the life sciences arena. These complex, large-molecule drugs have transformed the healthcare landscape, offering targeted and effective treatments for an array of diseases. As biopharmaceuticals continue to surge, the United States Food and Drug Administration (US FDA) plays a pivotal role in ensuring their safety and efficacy.
The landscape of drug discovery and development is experiencing a profound transformation, driven by the emergence of precision medicine. In this evolving paradigm, Quantitative Structure-Activity Relationship (QSAR) modeling emerges as a potent tool that has the potential to revolutionize the pharmaceutical industry. It is no longer just about discovering drugs; it is about crafting treatments as unique as the individuals they serve.
In the pharmaceutical arena, the assurance of patient safety is of prime importance. Moreover, the ICH guidelines highlight patient safety by upholding a harmonized approach to be followed by countries/ regions. One such pivotal guideline is ‘ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk’ which is detailed in the blog ahead. Furthermore, the blog uncovers its implications for the pharmaceutical landscape, and glimpses into the future it heralds for drug safety.
In the dynamic landscape of pharmaceutical development, the journey to ensure the equivalence of generic drugs to their reference counterparts is guided by rigorous scientific scrutiny. Bioequivalence studies stand at the forefront of this process, wielding the power to determine whether a generic drug performs on par with its innovator version. F-value stands to be the focal point in such an endeavor, a statistical parameter that holds the key to unraveling the intricacies of bioequivalence assessment.
Staying compliant with regulations is essential, and it is becoming increasingly difficult for organizations as Regulatory expectations continue to evolve and are sometimes specific to Regulatory Medical Writing or particular programs. This is often challenging for organizations with relatively less Regulatory experience that they have gathered from occasional submissions and for those working on entirely new therapeutic areas with innovative treatment modalities and approaches, including novel delivery technologies.
In the rapidly evolving fields of clinical research and Regulatory Affairs, the integration of advanced technologies is crucial for improving efficacy and safety documentation in Clinical Study Reports (CSR). Quantitative Structure-Activity Relationship (QSAR) is one of the leading technologies in CSR generation and processing. Global life sciences companies have implemented QSAR for its efficacy and usability. For more information on QSAR and how it can help achieve compliance in CSR, reach out to a specialist.
Health-based Exposure Limits (HBEL), also referred to as Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) values, are used to calculate Maximum Allowable Carryover (MAC/MACO) or Maximum Safe Carryover (MSC) limits in pharmaceutical cleaning validation. Similarly, Occupational Exposure Limit (OEL) values help ensure that the airborne concentration of pharmaceuticals is within acceptable limits so that workers are safe in manufacturing settings.
Regulatory writing essentially means developing various Regulatory documents for submission to Health Authorities (HAs). The documents must follow the relevant guidelines and convey the essential information accurately, transparently, and clearly to reviewers. Regulatory medical writers play a significant role in preparing documents and ensuring that they are accurate, concise, and compliant with the prevalent standards. This blog explores the key roles of medical writing and the qualities that need to be present in a medical writer.