Barbara Schug’s Post

Expert in Pharmacology and Biopharmaceutics

Exciting News: BfArM shortens #CTIS assessment times for national clinical trial applications! I was really happy to see that #BfArM has shortened the assessment times for all national #clinical #trials to 26 days, for mononational, monocentric trials even shorter timelines are possible. This is of utmost importance for all those studies run solely in Germany and of course it is of tremendous importance for all monocentric phase-I-studies in Germany. Look it up yourself: https://lnkd.in/eS-G8zZs

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Dr. Klaus Hellmann

Chief Veterinary Officer by Argenta, founder of KLIFOVET, part of the ArgentaGroup

Indeed a big step forward. Just the opposite what we currently see in animal health.

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Arslan Malik

Proposal Writer Clinical Trial Services at RQM+

Thank you for the post! It is great news since in this time trials need to be executed at a faster pace.

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Barbara Schug

Expert in Pharmacology and Biopharmaceutics
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Excellent oversight tool!
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Barbara Schug

Expert in Pharmacology and Biopharmaceutics
3w
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Thank you for the inspiring ideas and analysis - good to have you on board!

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Barbara Schug

Expert in Pharmacology and Biopharmaceutics
1mo
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What a pity that I cannot be there. I wish you all a marvellous meeting Greetings from the PQRI meeting in Rockville
AGAH e. V. Arbeitsgemeinschaft für Angewandte Humanpharmakologie

303 followers
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The #AGAH annual meeting is in full swing! It is always wonderful to experience #conferences like this! We love this awesome mixture of interesting scientific presentations and lively discussions between experts of various fields. This is the event to meet colleagues and like-minded people to spend a few days discussing the latest pharmacology news.
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Barbara Schug

Expert in Pharmacology and Biopharmaceutics
1mo
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6th GBHI meeting in Rockville was exciting and interesting until the last session EMA published the new draft of the Orally Inhaled Drug Products guideline exactly 5 days prior to the meeting Therefore, discussions were extremely interesting and challenging. Several aspects provoked a lot of discussions, as the stepwise approach of EMA is very much different to the “Weight of Evidence Approach” of FDA. In general, there were conflicting positions in terms of the option to approve OIPs based of in-vitro data only and whether AUC0-30 is acceptable as only primary endpoint in PK trials. However, it seems that at least FDA as well as EMA favour the overall concept of charcoal block studies for those APIs which exhibit relevant GI absorption. Furthermore, there was general consensus, that clinical endpoint studies and PD endpoint studies suffer from a lack of discriminating potential – in line with the EMA guideline draft. So – obviously a lot of potential for harmonisation of OIP requirements - maybe much more than origially expected. It was an honour for me to close the conference with greetings from EUFEPS board represented by the president Maria Blanco-Prieto and the BABP network lead Erem Bilensoy and with the statement that EUFEPS would be pleased to host the 7th GBHI conference next time in Amsterdam. #OIP, #FDA, #EMA, #GBHI
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Barbara Schug

Expert in Pharmacology and Biopharmaceutics
1mo
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2nd day of 6th GBHI starts with the session on partial AUC for bioequivalence demonstration Led by Mehul Mehta from #FDA and Jan Welink from MEB representing #EMA the discussion is very broad covering IR and MR formulations. The conference report will be interesting ...
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Barbara Schug

Expert in Pharmacology and Biopharmaceutics
1mo Edited
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I am really happy that my colleagues bring these topics forward: Digital endpoints as well as decentralised / virtual studies are important tools also for early phase trials. Ruwen Böhm, Annika Dax and Stephan Herrmann are real experts and it is extremely valuable that they share their knowledge and experience. Enjoy the conference and I am really disappointed that I cannot participate. However, the 6th #GBHI conference in Rockville, where I am currently, is also worth the trip!
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