Pharmaceutical Statistics

Cover image for Vol. 17 Issue 1

Edited By: David Morgan, John Scott and Jørgen Seldrup

Impact Factor: 1.276

ISI Journal Citation Reports © Ranking: 2016: 46/124 (Statistics & Probability); 210/257 (Pharmacology & Pharmacy)

Online ISSN: 1539-1612

Viewpoint Papers


Statistical issues in first-in-human studies on BIA 10-2474: Neglected comparison of protocol against practice
Shelia M. Bird, Rosemary A. Bailey, Andrew P. Grieve, Stephen Senn

Adaptive paediatric investigation plans, a small step to improve regulatory decision making in drug development for children?
Peter Bauer and Franz König

On the need for increased rigour and care in the conduct and interpretation of network meta-analyses in drug development
Kevin Carroll and Robert Hemmings

Idle thoughts of a ‘well-calibrated’ Bayesian in clinical drug development
Andrew P. Grieve

Estimands: discussion points from the PSI estimands and sensitivity expert group
Alan Phillips, Juan Abellan-Andres, Andersen Soren, Frank Bretz, Chrissie Fletcher, Lesley France, Andrew Garrett, Raymond Harris, Magnus Kjaer, Oliver Keene, David Morgan, Michael O'Kelly and James Roger

On the need for increased rigour and care in the conduct and interpretation of network meta-analyses in drug development
Kevin Carroll and Robert Hemmings

Viewpoint: model selection uncertainty, pre-specification, and model averaging
Björn Bornkamp

R&D productivity rides again?
Dennis Lendrem, Stephen J. Senn, B. Clare Lendrem and John D. Isaacs

Multiplicity and replicability: two sides of the same coin
Frank Bretz and Peter H. Westfall

The shrinking or disappearing observed treatment effect
Christy Chuang-Stein and Simon Kirby

Drug development: EU paediatric legislation, the European Medicines Agency and its Paediatric Committee—adolescents’ melanoma as a paradigm
Klaus Rose and Stephen Senn

European Federation of Statisticians in the Pharmaceutical Industry's position on access to clinical trial data
Christine Fletcher, Stefan Driessen, Hans Ulrich Burger, Christoph Gerlinger, Egbert Biesheuvel and on behalf of the EFSPI

Multiplicity: discussion points from the Statisticians in the Pharmaceutical Industry multiplicity expert group
Alan Phillips, Chrissie Fletcher, Gary Atkinson, Eddie Channon, Abdel Douiri, Thomas Jaki, Jeff Maca, David Morgan, James Henry Roger, and Paul Terrill

Strong control over multiple endpoints: are we adding value to the assessment of medicines?
Andrew Stone, and Christy Chuang-Stein

Viewpoint: observations on scaled average bioequivalence
Scott D. Patterson, and Byron Jones

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