How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum.

Purpose: A discussion forum was hosted by the Association for Applied Human Pharmacology (AGAH e.V.) to critically debate how to interpret and optimise the Investigator's Brochure (IB) for meaningful risk assessment of early clinical trials.

Unintended drug exposure during pregnancy in clinical trials - a survey in early drug development.

Purpose: To collect information on unintended drug exposure during pregnancy in early clinical drug development.

Materials And Methods: Questionnaire mailed in autumn 2015 to members of human pharmacology societies in Europe for anonymous responses via the online tool SurveyMonkey.

Results: 53 of the ~ 700 addressees participated in the survey.

European Federation for Exploratory Medicines Development Lyon Conference 2019: The Changing Landscape of Early Medicines Development-Be Prepared.

The second biennial conference of the European Federation for Exploratory Medicines Development (EUFEMED) was the result of a continued effort of EUFEMED to gather all stakeholders of exploratory clinical drug development to evaluate and discuss recent developments in the field. The conference focused on how the landscape around early clinical development is changing and how clinical pharmacologists might prepare for these changes. A preconference workshop gave consideration to the impact that modeling and simulation, including physiology-based pharmacokinetic strategies, is having on the practice of clinical development.

The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum.

The European Federation for Exploratory Medicines Development (EUFEMED) organized a meeting in Leuven, Belgium entitled 'The new FIH EMA guideline: Disruptive or constructive?' to provide a forum for stakeholders to discuss the guideline's operational impact. The revised EMA Guideline on strategies to identify and mitigate risks for first-in-human (FIH) and early clinical trials with investigational products was published on 20 July 2017. The revision gave guidance on sentinel dosing/staggering of subjects within a multiple-ascending dose (MAD) clinical trial, permissible maximum exposure/investigation of supra-therapeutic doses and dose escalations above the no-observed adverse effect level.

Use of integrated clinical trial protocols - A survey in early medicines development .

Purpose: To collect information on the use of integrated protocols in early clinical medicines development.

Materials And Methods: The questionnaire was mailed in fall 2014 to members of human pharmacology societies in Europe for anonymous responses via the online tool SurveyMonkey.

Results: 97 respondents reported on 164 integrated protocols overall.

EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management.

The first formal conference of the EUropean Federation for Exploratory MEdicines Development (EUFEMED) held in London was the result of a collaborative effort of its founding associations: the Association for Applied Human Pharmacology (AGAH; Germany), the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI; UK), the Belgian Association of Phase-I Units (BAPU; Belgium), and Club Phase-I (France). The conference focused on innovation and risk management in early clinical drug development. Among other innovations, immunotherapy in oncology and inflammatory diseases were discussed as well as the importance of adaptive trial designs in early clinical drug development.

Who is a 'healthy subject'?-consensus results on pivotal eligibility criteria for clinical trials.

Introduction/methods: A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key eligibility criteria and stopping rules for clinical trials with healthy subjects, enrolling stakeholders from the pharmaceutical industry, contract research organisations, academia, ethics committees and competent authority.

Severe tardive dyskinesia in affective disorders: treatment with vitamin E and C.

Tardive dyskinesia caused by antipsychotic treatment is a severe problem not only in the management of schizophrenia, but also of affective disorders. Vitamin E monotherapy has been used in schizophrenic patients with tardive dyskinesia. Pharmacologists warn against high dosage of vitamin E because of its pro-oxidative effects on low-density lipoprotein with consecutive cardiac risks.