Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0268596 (EMA)
 2,520 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges. Materials and Methods: The current valid guidelines of EMA, WHO, USFDA, BGTD/HC, ICH, and BRICS-TM were obtained from official websites and comparative qualitative review was performed. Results: The review revealed that Health Canada uses mAb specific guidelines from EMA or USFDA when necessary. The BRICS agencies (except Russia) have incorporated some or most of the WHO SBP TRS and related annexes in similar national biotechnological/biological guidelines; however, gaps or insufficient information have been identified. The Russian Federation has issued general product registration guideline/s with very brief information about mAbs. The TMMDA (Turkey) has published an updated biosimilar guideline which parallels those of the EMA and the ones from WHO; however, no mAb specific guidelines are published. COFEPRIS (Mexico) has published a biotechnological/biological product registration guideline with no information about mAb. The SAHPRA biosimilar guideline has an annex on mAbs which focuses on non-clinical and clinical aspects. The comparative evaluation of BRICS-TM agencies indicates a gap pertaining to clarification for physico-chemical characterization, manufacturing process, overages and compatibility requirements between biological substances and excipients specifically on mAbs. In vitro assay requirements seem quite aligned with those of WHO, whereas in vivo studies mostly have disparity in terms of necessity, type of studies as well as design and criteria. Clinical safety and efficacy studies are indicated in emerging regulatory agencies, however detailed information pertaining to design, size of populations, requirements for primary and secondary endpoints, clarity and evaluation criteria differ. In general, BRICS-TM agencies allow extrapolation of indications provided that pre-defined conditions are met. Interchangeability, switching and substitution of biosimilars are not defined in most of BRIC-TM guidelines whereas South Africa, by law, allows neither interchangeability nor substitution. Pediatric research remains questionable across BRICS-TM. Conclusions: EMA, USFDA guidelines are broadly aligned with WHO and in addition, they also contain specific requirements pertaining to their own region. BRICS-TM has considerably less defined mAb specific biosimilar development and comparability parameters in their published guidelines.
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PMID:Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines. 3036 54

In every developed and developing country, the major facing problem is heavy metals toxicity. Due to there is an increase in the heavy metals anthropogenic in day to day life by various factors, which are causing serious issues or harmful health hazardous for all types of living organisms. Moreover, they are present everywhere in the universe it causes the contamination of the food, dietary, and processed materials. Accordingly, the present review article further summarizes the studies related to the determination of lead as a toxic impurity with a total of 134 references in the period 2000 to 2018. In this write-up, emphasize the one of the highly toxic heavy metal element Lead (Pb) and it's toxicity in the animals, humans, plants, and aquatic systems. In addition, the purpose of this article is to evaluate the effectiveness of established analytical techniques and trends in analytical methods like AAS; ICP-OES; ICP-MS; ASV; X-ray fluorescence spectrometry, these techniques significantly applicable for the quantitative analysis of Pb in various sources. The various regulatory authorities for Pb throughout the globe like IOSH, EPA, EMA, and CDCSO. This reveals the need and scope of further research in the field of heavy metal toxicity and development of new analytical techniques in meeting the needs of the life scientists. The present comprehensive review is an attempt to transform the state of knowledge into the findings that may act as a guideline for all the interested groups at different levels.
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PMID:The toxicological effects of lead and its analytical trends: an update from 2000 to 2018. 3165 Aug 60