- Pharmacovigilance is a critical field in healthcare that focuses on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. A cornerstone of pharmacovigilance is causality assessment, which is the systematic evaluation of the evidence to determine whether a drug caused a particular adverse event.
Artificial Intelligence Revolution in Literature Surveillance
Traditionally, literature surveillance has been an effort-intensive process, requiring pharmacovigilance specialists to manually search, review, and analyze vast amounts of published/ unpublished data for potential adverse events (AEs) and safety-related information. However, Artificial Intelligence (AI), with its machine learning (ML) and natural language processing (NLP) capabilities, is changing the game.
Unlocking the Synergy: Digital Health Technologies and Regulatory Mastery in Clinical Investigations
The integration of Digital Health Technologies (DHTs) heralds a transformative era in the realm of clinical investigations. From computing platforms to wearables, these technologies redefine the landscape, offering an innovative lens for evaluating medical products. The blog acts as a compass for sponsors and investigators, and navigates the nuanced terrain of DHTs, underscoring their potential in remote data acquisition.
GCP/ GLP monitoring & audit – Ensuring the data quality & integrity
Good clinical practice (GCP) and good laboratory practice (GLP) are quality standards that ensure the safety, reliability, and integrity of clinical trials and laboratory studies. GCP and GLP monitoring and audit are essential activities to verify compliance with these standards and identify any gaps or issues that need improvement.
Importance of Regulated Bioanalysis in Clinical Research
Bioanalytical reports are essential documents that present the results of measuring drug concentrations, metabolites, biologics, and biomarkers in biological matrices (e.g., blood, serum, plasma, saliva, urine, CSF, or tissue), an essential aspect of therapeutic product development. They provide the basis for pharmacokinetic and toxicokinetic evaluations and support regulatory submissions. These essential documents demonstrate the quality and validity of the data obtained from measuring drug concentrations or biomarkers in biological samples.
Leveraging the marvel of QSAR in Post-Marketing Surveillance
Introduction
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.
Harnessing the Role of Regulatory Vendors in streamlining Clinical Trial Regulation (CTR)
Introduction
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.
Rise of Biopharmaceuticals: A US FDA's Perspective and the Crucial Role of Regulatory Vendors
Introduction
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.
Exploring QSAR in the Era of Precision Medicine & Drug Design
Introduction
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.
Comprehending ICH M7(R2) Guidance on DNA Reactive Impurities for Pharmaceuticals
Introduction
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.