Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in ensuring patient safety and optimizing the benefits of pharmaceutical products throughout their lifecycle. Here’s a detailed note on pharmacovigilance: 1. Overview …
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Clinical trial phase: Definition, Objectives and Phases
The clinical trial phase is a crucial stage in drug development where investigational drugs are tested in human subjects to assess their safety, efficacy, and optimal dosage regimens. These trials are conducted in a series of phases, each designed to address specific research objectives and regulatory requirements. Here’s a detailed …
Preclinical evaluation phase
The preclinical evaluation phase is a critical stage in drug development that occurs before testing in human subjects. It involves a comprehensive assessment of the safety, pharmacokinetics, pharmacodynamics, and toxicology of a potential drug candidate using in vitro and in vivo models. Here’s a detailed note on the preclinical evaluation …
Drug Discovery and Clinical Evaluation of New Drugs
Drug discovery is a complex and multifaceted process aimed at identifying and developing new pharmaceutical compounds for the treatment of various diseases. It involves a series of steps, each with its own challenges and considerations. Here’s a detailed note on the drug discovery phase: 1. Target Identification and Validation …
Drug Interactions: Introduction, Mechanism, etc
Drug interactions occur when two or more drugs interact with each other, altering their pharmacological effects, leading to either potentiation or diminution of therapeutic effects or causing adverse reactions. These interactions can occur via pharmacokinetic or pharmacodynamic mechanisms. 1. Pharmacokinetic Drug Interactions Pharmacokinetic drug interactions occur when one drug affects …
Adverse Drug Reactions (ADRs)
Adverse Drug Reactions (ADRs) refer to unintended and harmful reactions that occur in response to the administration of medications at normal therapeutic doses. These reactions can manifest in various forms, ranging from mild discomfort to severe adverse effects, and they can occur immediately after drug intake or after prolonged use. …
Factors Modifying Drug Action: Definition and Factors affecting
The action of a drug within the body can be influenced by various factors that modify its pharmacokinetics (absorption, distribution, metabolism, excretion) and pharmacodynamics (interaction with target receptors or enzymes). Understanding these factors is crucial for optimizing drug therapy and ensuring patient safety. Physiological Factors – Age: Age-related changes in …
Combined Effects of Drugs: Definition, Types and Examples
The combined effects of drugs, also known as drug interactions, occur when two or more drugs are taken together, altering their individual effects on the body. These interactions can lead to enhanced therapeutic effects, diminished efficacy, or an increased risk of adverse reactions. Understanding drug interactions is crucial for healthcare …
Therapeutic Index (TI): Definition, Concept, Interpretation and Calculation
The therapeutic index (TI), also known as the therapeutic window, is a critical pharmacological parameter used to assess the safety and efficacy of a drug. It quantifies the relative safety of a medication by comparing the dose required to produce therapeutic effects with the dose that causes toxicity. In this …
Dose-Response Relationship: Understanding How Much is Too Much
The dose-response relationship is a fundamental concept in toxicology, pharmacology, and many other scientific fields. It describes the relationship between the amount of a substance (the dose) an organism is exposed to and the resulting effect (the response). By understanding this relationship, scientists can determine safe and effective doses of …
