In the following, we would like to update you on current changes in the regulatory framework (OECD, ICH and others), inform you on upcoming congresses (including where you can meet us in person) and add information on the company and recent novelties.

“In our own case”

Meet us in Cologne

The 47th Annual Meeting of the European Teratology Society and the 17th European Congress of Toxicologic Pathology are moving closer and will be held in parallel Sept 17-20 at the Maternushaus in Cologne. It would be a great opportunity to meet personally with Prof. Robert Klopfleisch and Dr. Geertje Lewin, to discuss questions and projects, share
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Changes in Company Management

Lars Mecklenburg,  co-founder of PRECLINICAL SCIENCE, has decided to discontinue consulting. Lars will no longer accept new clients but will be available for existing clients regarding previous projects. His reponsibilities around pathology have been transferred to Robert Klopfleisch and his duties around preclinical drug development projects have been taken over by Roman Föll and Geertje
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Alternative Advances in Zoological and Medical Terminology

The discovery and detailed scientific description of new zoological and medical entities is a slow and work intensive process. After the scientific description of the genus Rhinogradientia (by Gerolf Steiner, 1961) and the species Steinlaus (Petrophaga lorioti, 1976), finally the medical world now faces the first detailed work on etiology, epidemiology, clinical symptoms and treatment
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Dates / Congresses

2022 ETS ReproTox Education Course

As already in 2021, the European Teratology Society is offering a certified (DGPT, RSB) education Course in Reproductive Toxicology in February 2022. The online course will incorporate basic physiology, specific organ development, guideline requirements and study designs, new science developments and much more. For registration, please visit the society’s website at
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EUROTOX 2020 postponed

Yesterday, the decision was made by the EUROTOX Executive Committee to postpone to 2021, the EUROTOX 2020 Copenhagen congress scheduled to take place September 6-9. This was not a decision taken lightly, and a number of options were investigated and discussed in conjunction with the Local Organising Committee (LOC) in Denmark, and the PCO, K.I.T.
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FMP at the 5th German PharmTox Summit

Dear colleagues, in about a month, the 5th German PharmTox Summit will be held March 2-5th in Leipzig. It will be our pleasure to meet with colleagues and have time for networking. Furthermore, we will present a poster summarizing new approaches in QSAR analyses for potentially mutagenic impurities in pharmeucitals and medical devices from our
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Legislative change

New implementation or update of OECD Guidelines

Over the last 3 months, a variety of OECD guidelines for in vitro toxicity testing has been newly implemented or updated. The current versions can be downloaded via the PDF link. OECD 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method  PDF OECD 432: In Vitro 3T3 NRU Phototoxicity Test  PDF OECD 439: In Vitro
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New EMA Draft Guideline for Environmental Risk Assessment of Medicinal Products

At the end of 2018, the European Medicines Agency published the new draft Guideline on the environmental risk assessment of medicinal products for human use  for public consultation. Deadline for comments will be 30 June 2019.
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Nonclinical Safety Testing Guideline S11

ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) issued the first draft of guideline S11 on Nonclinical Safety Testing in Support of Development of Pediatric Medicines in September 2018.
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Worth knowing from the authorities

Products for parenteral diet in preterm babies – need of light protection

The following warning was recently issued by the Drug Commission of the German Medical Association concerning parenteral diet in preterm babies. Due to the immaturity of the intestinal tract and immune system, liver metabolism and detoxifying mechanisms, parenteral diet has to be protected from light during storage and treatment. Otherwise these drugs, containing amino acids
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EFSA Dietary Reference Values

The European Food Safety Authority published their “Dietary Reference Values for Nutrients” in a Summary Report. Dietary reference values (DRVs) is an umbrella term for the complete set of nutrient reference values which include population reference intakes (PRIs), the average requirements (ARs), adequate intakes (AIs) and reference intake (RIs) ranges for macronutrients. In 2005, the European
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BfS Annual Report 2017/18 published

The Federal Office for Radiation Protection (BfS) issued its Annual Report 2017/2018, including updates on prevention of UV-associated diseases, on the situation of radiation protection for patients in medicine and on occupational radiation protection.     
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From the science community

Analysis of Plant Toxins

The German Society of Toxicology just issued an urgent request for their members. Please consider and reply: Liebe GT-Mitglieder,der operativ/analytische Bereich der ATF Köln  (Analytische Task Force bei der Feuerwehr Köln) hat uns kontaktiert und bittet um Mithilfe unserer Gesellschaft für Toxikologie. Die Aufgabe der ATF ist  die Unterstützung insb. des Rettungsdienstes und der Feuerwehren, im  Einzelfall auch von
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New Breakthrough in Orphan Disease Diagnostics?

Any disease affecting fewer than 5 people in 10,000 in the EU is considered rare or an “Orphan Disease”. Although this might appear small, it translates into approximately 246,000 people. Most patients suffer from even rarer diseases affecting 1 person in 100,000 or more. Approximately 5,000-8,000 distinct rare diseases affect 6-8% of the EU population
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Dysgeusia after drug treatment

A not so uncommon side effect after drug treatment are changes in taste (dysgeusia) or loss of taste (ageusia). A wide range of drugs may cause these this sensual alteration, including but not limited to anticholinergic drugs, anti-diabetics, sedativa, antibiotics, dopamine receptor antagonists and certain anti-hypertensive drugs. Examples Hypogeusia: Amphotericin B, Carbamazepin, Cisplatin, Diltiazem, Carboplatin, Levodopa,
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