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Клинические испытания лекарственных средств с участием детей – Добавление к ICH E11

  • 17 октября 2017
  • ICH E11, клинические испытания, клинические исследования, компьютерная симуляция, компьютерное моделирование, лекарственные формы для детей, педиатрическая популяция, разработка лекарственных препаратов, разработка лекарственных средств, экстраполяция,
On 6 October 2017, the European Medicines Agency (EMA) published revised version of ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population in the form of an addendum. This document will become effective on 28 February 2018. Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration
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(Q)SAR models – important tool of risk assessment to support practical implementation of ICH M7 guideline

  • 29 сентября 2017
  • (Q)SAR, GTIs, ICH M7, генотоксические примеси, квалификация примесей, КССА, мутагенные примеси, принципы валидации, прогнозирование мутагенности, тесты на мутагенность,
A general concept of qualification of impurities (or degradation products) is described in the ICH Q3A/B guidelines, whereby qualification is defined as the process of acquiring and evaluating data that establishes the biological safety of an individual impurity (or degradation product) or a given impurity (or degradation) profile at the level(s) specified. Therefore to limit
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Пересмотренные руководящие принципы первых клинических исследований на людях – FIH CTs (Part II)

  • 30 июля 2017
  • 1 фаза, FIH, IMP, интегрированный протокол клинического исследования, исследуемый препарат, начальные клинические испытания, первые исследования на людях, первые клинические испытания на людях, снижение риска,
On 25 July 2017, the European Medicines Agency (EMA) published revised version of Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. This revised document will become effective on 1 February 2018. We have already informed on our website about a draft of the revised guideline
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Первые клинические испытания на людях – FIH CTs (Part I)

  • 12 апреля 2017
  • 1 фаза, FIH, IMP, замена, интегрированный протокол клинического исследования, исследуемый препарат, концепция 3R, начальные клинические испытания, первые исследования на людях, первые клинические испытания на людях, снижение риска, сокращение, усовершенствование,
Clinical trials are essential for the development of medicines and without them patients cannot gain access to new potentially life-saving medicines. EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. EMA’s existing guideline, released in 2007, provides advice on first-in-human clinical trials, in particular on
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GMP and MAHs

  • 13 октября 2016
  • 2019/6, EU, GMP, MAH, regulation, владелец регистрационного удостоверения лекарственного препарата, держатель регистрационного удостоверения лекарственного препарата, НПП,
Update [18/11/2021] On 29 July 2021, the European Medicines Agency (EMA) published final version of Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders. This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies and it seeks to provide clarity as to what the various responsibilities are
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Recently, FDA has published a new technical specifications document entitled Quality Metrics Technical Conformance Guide. This Guide supplements and serves as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality Metrics and additionally provides recommendations about submission of information that will support the FDA’s calculation of quality metrics.
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On 29 April 2016, EMA published a new document entitled Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission. The new guideline will become effective on 1 November 2016. It should be noted that the need to develop guidance on process validation of biotechnology
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On 13 April 2016, EMA released for 6 months public consultation the Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. A new guidance is developed as a separate guidance document and will replace Decision trees for the selection of sterilisation methods (CPMP/QWP/054/98) and Decision trees for the selection
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On 19 January 2016, the European Medicines Agency published a new document entitled Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances. This document is intended to reflect the current experience concerning the definition of a New Active Substance (NAS) in
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On 28 July 2015, FDA published a draft guidance for industry entitled “Request for Quality Metrics”. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Quality metrics are used throughout the pharmaceutical industry to monitor
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