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Fotolabilność substancji leczniczych – przegląd aktualnych badań i strategie postepowania

100%

Jamrógiewicz M. , Karczewska-Kaliszak A. , Milewska K.

Farmacja Polska

2019

tom 75

nr 10

575-583

The main procedure for stability testing of Active Pharmaceutical Ingredients (API) and medicinal products is described in the guidelines of the International Council for the Harmonization of Technical Requirements for Human Drugs (ICH). However, these guidelines do not contain specific procedures and methodologies that must be followed in stress testing, especially photostability tests. On the basis of the latest, current research reports which have been published, as well as scientific literature this article provide current information about photolabile medicinal compounds, the structure and properties of their degradation products, as well as various strategies of proceedings. The ICH Q1B guidelines cover two main types of tests, namely 'forced degradation' and 'confirmatory' tests for medicinal products and medical devices and supplements. Forced degradation studies are used to explain the mechanisms of photodegradation and to develop procedures for the proper production, packaging, storage, clinical / production use of the active pharmaceutical ingredient and the final product. These studies are also aimed at developing an appropriate analytical method capable of visualizing potential changes occurring in the medicinal product or demonstrating the specificity of an already existing method. The "confirm" test, as the name suggests, is intended to confirm that the recommended storage conditions and packaging of the medicine are adequate and sufficient to protect the medicinal product. Light exposure for confirmatory testing roughly reflects exposure to typical ultraviolet and visible light for 3 months in case of a medicinal product without protective packaging in a pharmacy, warehouse or home (in the United States / Northern Europe). Therefore, for geographical locations with a greater number of hours and greater sunlight intensity, this period is much shorter. Such test guidelines are determined depending on the geographical location (zone) of the country in which they take place. People believe that product they use and eat are safety while most of the society are convinced that current guidelines concerning quality evaluation of medicinal products are unified and concentrate on verification of stability through determination by particular tests. The purpose of this review is to discuss with criticism all current recommendations referring to the photostability tests performed for pharmaceutical industry mostly connected with human life as pharmacy. The estimation of all existing and obligatory requirements with their gaps are discussed.

Podstawowa procedura przeprowadzania badań trwałości substancji leczniczych i produktów leczniczych opisana jest w wytycznych Międzynarodowej Rady Harmonizacji Wymagań Technicznych dla Leków Stosowanych u Ludzi, tzn. ICH (ang. International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). Wytyczne te nie zawierają jednak szczegółowych procedur i metodologii eksperymentalnej, których należy przestrzegać podczas przeprowadzania testów stresowych, zwłaszcza dotyczących fotostabilności. Na podstawie najnowszego piśmiennictwa naukowego, w pracy przedstawiono testy i różnorodne badania, które dostarczają informacji o fotolabilnych substancjach leczniczych, strukturze i właściwościach produktów ich degradacji, a także różnych strategiach postępowania.

Assessment of CT for the categorization of hemorrhagic stroke (HS) and cerebral amyloid angiopathy hemorrhage (CAAH): A review

71%

Sudarshan V. K. , Raghavendra U. , Gudigar A. , Ciaccio E. J. , Vijayananthan A. , Sahathevan R. , Acharya U. R.

Biocybernetics and Biomedical Engineering

2022

tom Vol. 42, no. 3

888--901

The management of intracerebral hemorrhage (ICH) requires prompt diagnostic assessment and recognition. Accurate localization and categorization of ICH-type is crucial. There are two main categories of ICH: 1) hemorrhagic stroke (HS), which occurs in the deeper or subcortical regions of the brain, where the arterial network tapers to fine end-arteries, and, 2) cerebral amyloid angiopathy hemorrhage (CAAH), which occurs at the superficial or cortical-subcortical region of the grey and white matter junction. Computed tomography (CT) and magnetic resonance imaging (MRI) are the most used imaging tools in diagnosing ICH. However, availability, time, and cost often prevent emergent MRI use. Therefore, CT remains the primary tool in the diagnosis of ICH. The assessment of imaging studies is time-dependent, and a radiologist should do a detailed diagnostic evaluation. Human error can occur in a pressured clinical setting, even for highly trained medical professionals. Assisted or automated computer-aided analysis of CT/MRI may help to reduce the assessment time, improve the diagnostic accuracy, better differentiate between types of ICH, and reduce the risk of human errors. This review evaluates CT and MRI’s role in distinguishing between the two varieties of ICH-HS and CAAH. It focuses on how CT could be utilized as the preferred diagnostic tool. In addition, we discuss the role of automation using machine learning (ML) and the role or advantages of ML in the automated assessment of CT for the detection and classification of HS and CAAH. We have included our observations for future research and the requirements for further evaluation.