Signal Detection in Pharmacovigilance: Emerging Methodologies and Clinical Implications

Sat, 01 Aug 2026 00:00:00 +0000

Pharmacovigilance plays a pivotal role in the global healthcare landscape, offering crucial insights to maintain and improve the safety and efficacy of medicines by continuously detecting, assessing, understanding and preventing adverse drug reactions (ADRs). Signal detection, an integral aspect of pharmacovigilance, refers to the detection of previously unrecognized or partially documented safety issues early in the life of a drug. Historically, spontaneous reporting systems, coupled with disproportionate analysis techniques, were indispensable to drug safety surveillance, but suffered from major drawbacks such as underreporting, reporting biases, and lack of sufficient information. However, the use of Artificial Intelligence (AI), machine learning, natural language processing, big data analysis, and real-world evidence (RWE) has provided unprecedented capabilities for safety signal discovery and verification, thus paving the way for efficient identification and verification of potentially harmful drugs. Subsequent to the detection of an initial safety signal, thorough validation, risk assessment, and subsequent regulatory review of its clinical relevance are mandatory to ensure adequate regulatory action and decision-making based on scientific evidence. This article discusses the basic principles, novel approaches, regulations, and prospects of signal detection and its contribution to global health and patient safety.

Formulation and Characterization of Polyherbal Cream for Wound Healing and Antimicrobial Activity

Tue, 15 Sep 2026 00:00:00 +0000

The current study used natural herbal elements like Tridax procumbens, neem (Azadirachta indica), turmeric (Curcuma longa), and turpentine oil to create and assess a polyherbal cream with antibacterial and wound-healing properties. Due to their medicinal efficacy, safety, affordability, and low side effects as compared to synthetic formulations, herbal medications are frequently used. The chosen herbs are widely recognized for their wound-healing, antibacterial, anti-inflammatory, and antioxidant qualities. The plant materials were gathered, verified, dried, and extracted using appropriate extraction techniques such as maceration and Soxhlet extraction.

Three distinct concentrations of herbal extracts were combined with excipients such as glycerine, cocoa butter, liquid paraffin, borax, methyl paraben, and rose water to create three formulations (F1, F2, and F3) of polyherbal cream. Numerous physicochemical characteristics, including color, odor, texture, homogeneity, pH, spreadability, washability, phase separation, irritancy, and thermal stability, were assessed for the prepared creams. All of the formulations’ pH values were found to be within the permitted range for skin application, indicating good skin compatibility. Because of the herbal ingredients’ synergistic action, the formulations’ antibacterial activity showed efficient suppression of microorganisms that infect wounds. Improved tissue regeneration, less inflammation, and quicker epithelialization were seen in the wound healing study.

Out of all the formulations, F2 demonstrated greater antibacterial and wound healing activity as well as improved stability, spreadability, and uniformity. The irritancy investigation found no evidence of skin irritation or allergic responses, indicating that the formulation is safe for topical use.

Journal of Advances in Bio- pharmaceutics and Pharmacovigilance (e-ISSN: 2583-8202)

Signal Detection in Pharmacovigilance: Emerging Methodologies and Clinical Implications

Formulation and Characterization of Polyherbal Cream for Wound Healing and Antimicrobial Activity