Month: March 2024

What & How (AI) Artificial-Intelligence used in medicine (Pharmaceuticals)in 2024

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What & How (AI) Artificial-Intelligence used in medicine (Pharmaceuticals)in 2024 Artificial-intelligence: What is (AI) artificial intelligence in medicine in 2024. Artificial intelligence (AI) in medicine refers to the use of advanced computational techniques to analyze medical data, make predictions, assist in diagnosis, develop treatment plans, and improve overall patient care. It encompasses various AI technologies …

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Amazing Application of Artificial Intelligence (AI) in the pharmaceutical industries-2024

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Amazing application of artificial intelligence (AI) in the 2024 pharmaceutical industries Amazing application of artificial intelligence in pharma, throughout our journey, humanity has traversed a vast terrain in pursuit of understanding AI. Since the dawn of digitalization, mainstream media has portrayed artificial intelligence as a complex entity poised to tackle the existential challenges of human …

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What is Bioavailability and Bioequivalence Study 2024

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What is Bioavailability and Bioequivalence Study? What is Bioavailability and Bioequivalence Study? Bioavailability refers to the proportion of a drug from a given dose that enters the bloodstream and the speed at which it reaches systemic circulation. Assessing bioavailability involves measuring drug concentrations in plasma or blood following standardized administration protocols, documented over time. These …

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How to Estimate of pharmacokinetic parameters (CDISC) using Microsoft Excel 2019-estimation

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Estimate of pharmacokinetic parameters. From non-Compartmental data using -Microsoft Excel-24 Estimate of pharmacokinetic parameters (CDISC) using Microsoft Excel-estimation , Pharmacokinetic parameters, such as clearance (CL) and volume of distribution (V), represent constants that vary based on the model used, illustrating the relationship between drug input (dose, dosing interval, dosing time, sampling times) and output (drug …

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Overview of Statistical Concepts-Bioequivalence Pharmacokinetics-24

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Overview of statistical concepts-Bioequivalence Pharmacokinetics INTRODUCTION Overview-of-statistical-concepts-bioequivalence, Current global regulatory agencies mandate that the final assessment of an oral medication\’s quality relies on its in vitro dissolution behavior, along with in vivo bioavailability and/or bioequivalence evaluations. The latter hinges on the assumption that the drug concentration in systemic circulation equates to its concentration at the …

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What is Drug products approval System Regulatory affairs in 2024

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What is Drug products approval System Regulatory affairs in 2024 Authorization in drug products Drug products approval system Regulatory affairs, A medicinal product, whether intended for human or veterinary use, must obtain a valid Marketing Authorisation (MA) before it can be legally sold and supplied in the market. The entity holding the Marketing Authorisation, known …

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How eCTD 4.0 implementation in Regulatory Affairs

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How eCTD 4.0 implementation in Regulatory Affairs eCTD 4.0 – The electronic Common Technical Document (eCTD) is standardized guideline for submitting regulatory information to health authorities (HAs). It streamlines the process of electronically implementing the Common Technical Document (CTD). An eCTD comprises individual PDF documents organized hierarchically according to the CTD structure. Additionally, it features …

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