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The Naranjo Algorithm, developed in 1981 by Naranjo et al., is a structured, questionnaire-based tool used to assess the probability that a drug caused an adverse drug reaction (ADR). It is widely used in pharmacovigilance and clinical research to standardize causality assessment. Structure of the Naranjo Algorithm The Naranjo algorithm consists of 10 questions, each […]
Introduction to Causality assessment Causality assessment is a critical process in pharmacovigilance aimed at determining whether a specific drug is responsible for an observed adverse drug reaction (ADR). It helps in identifying the strength of the relationship between drug exposure and the adverse event. Causality assessment is complex, as multiple factors like the patient’s condition, […]
Introduction to Adverse Drug Reactions Adverse Drug Reactions (ADRs) are an essential aspect of drug safety monitoring and are critical for ensuring the safe use of medicines. According to the World Health Organization (WHO), an ADR is defined as any unintended, harmful reaction to a drug administered at normal doses for prevention, diagnosis, or treatment. […]
Aim: Determination of Erythrocyte Sedimentation Rate (ESR) References: 1. Bull, B. S., & Brecher, G. (2005). Clinical Hematology: Principles, Procedures, Correlations. Lippincott Williams & Wilkins. 2. Lewis, S. M., Bain, B. J., & Bates, I. (2006). Dacie and Lewis Practical Haematology. Churchill Livingstone. 3. International Committee for Standardization in Haematology (ICSH) Guidelines for ESR measurement. […]
Aim: Determination of pA₂ Value of Prazosin Using Rat Anococcygeus Muscle (Schild Plot Method) References 1. Arunlakshana, O., & Schild, H.O. (1959). Some quantitative uses of drug antagonists. British Journal of Pharmacology and Chemotherapy, 14(1), 48-58. 2. Ghosh, M.N. (2008). Fundamentals of Experimental Pharmacology (6th ed.). Hilton & Company. 3. Rang, H.P., Dale, M.M., Ritter, […]
Aim: Bioassay of Serotonin Using Rat Fundus Strip by Three-Point Bioassay References 1. Ghosh, M.N. (2008). Fundamentals of Experimental Pharmacology (6th ed.). Hilton & Company. 2. Rang, H.P., Dale, M.M., Ritter, J.M., & Flower, R.J. (2015). Rang & Dale’s Pharmacology (8th ed.). Churchill Livingstone. 3. Schild, H.O. (1947). The bioassay of serotonin on the rat […]
1. In-Process Quality Control (IPQC) Tests for Capsules In-process quality control tests are performed during different stages of manufacturing to monitor the product and ensure consistency. These tests help in identifying and correcting deviations before the final product stage. 1.1 Weight Variation Test Purpose: To ensure consistent dosage of the active pharmaceutical ingredient (API) in […]
Hard gelatin capsules are a popular solid dosage form, consisting of two parts: a body and a cap. These capsules are primarily composed of gelatin, which acts as the capsule shell, providing an efficient medium for delivering powdered, granulated, or semi-solid drugs. Filling of Hard Gelatin Capsules The filling process for hard gelatin capsules can […]
Capsule Sizes: Capsules are a common dosage form in pharmaceuticals, offering flexibility for delivering various active ingredients. Capsules come in a range of sizes to accommodate different dosages, allowing pharmaceutical manufacturers to select the best option based on the volume and weight of the formulation. Understanding capsule sizes is essential for proper dosage and patient […]
Hard Gelatin Capsules: Capsules are a popular and versatile dosage form for delivering medications, dietary supplements, and other substances orally. They are small, cylindrical, and often filled with powder, granules, semi-solids, or liquids, designed to encapsulate the active ingredients. Capsules are primarily classified into two types: hard gelatin capsules and soft gelatin capsules. This note […]
