Results 121 to 130 of about 790,096 (261)

A Bayesian Adaptive Design for Assessing Treatment Effect Consistency in Bridging Studies

Statistics in Medicine, Volume 45, Issue 23-24, October 2026.
ABSTRACT Bridging studies serve as an efficient approach to evaluate the applicability of findings from an original study to a new population. We propose a Bayesian adaptive design for bridging studies with time‐to‐event endpoints, aiming to assess the consistency of treatment effects with those observed in the original study. The design adopts a group
Xinyi He, Dan Zhao, Zhaoyang Teng, Hua Liu, Ying Yuan   +4 more
wiley   +1 more source

EU Enlargement, Parallel Trade and Price Competition in Pharmaceuticals - What’s to Blame? Derogation or Perception? [PDF]

Given the cost of trade and availability of pharmaceuticals, the driving force for parallel trade is the price difference between the source (exporting) and the destination (importing) country.
Granlund, David, Yesim Köksal, Miyase
core  

Review on lipegfilgrastim

International Journal of Nanomedicine, 2015
Maja Gasparic, Sophie LeymanTeva Pharmaceuticals Europe BV, European Headquarters, Amsterdam, the NetherlandsHaving read the original Hoggatt et al article1 and the corrigendum published online on August 27, 2015,2 we do not consider the description of ...
Gasparic M, Leyman S
doaj  

Evolution of Biosimilar Medicines on the Romanian Pharmaceutical Market

Acta Pharmaceutica Hungarica, 2021
Emese Sipos, Emőke Rédai, Ibolya Fülöp   +2 more
openaire   +1 more source

Net Present Value Impact of FDA’s Phase 3 Waivers on Monoclonal Antibody Biosimilar Development

Biologics: Targets & Therapy
Ranjit Ranbhor,1 Priyanka Kulkarni2 1Business Development, Portfolio and Patents, Odin Pharmaceuticals LLC, Somerset, NJ, USA; 2Feliciano School of Business, Montclair State University, Montclair, NJ, USACorrespondence: Ranjit Ranbhor, Business ...
Ranbhor R, Kulkarni P
doaj  

Incidence of febrile neutropenia during chemotherapy among patients with nonmyeloid cancer receiving filgrastim vs a filgrastim biosimilar

ClinicoEconomics and Outcomes Research, 2018
Lee S Schwartzberg,1,2 Lincy S Lal,3 Sanjeev Balu,4 Kim Campbell,4 Lee Brekke,3 Caitlin Elliott,3 Stephanie Korrer3 1West Cancer Center, Memphis, TN, USA; 2Division of Hematology and Oncology, University of Tennessee, Memphis, TN, USA; 3Health Economics ...
Schwartzberg LS, Lal LS, Balu S, Campbell K, Brekke L, Elliott C, Korrer S   +6 more
doaj  

A PHARMACEUTICAL GUIDE TO ADALIMUMAB BIOSIMILARS

FARMACIA, 2022
openaire   +1 more source

Impact of biosimilar medicinal products in the EU pharmaceutical market [PDF]

Clinical Therapeutics, 2015
A. Grozdanova, K. Ancevska Netkovska, Z. Sterjev, Z. Naumovska, A. Kapedanovska Nestorovska, L.j Suturkova   +5 more
openaire   +1 more source

Investments in Pharmaceuticals Before and After TRIPS [PDF]

We examine the relationship between patent protection for pharmaceuticals and investment in development of new drugs. Patent protection has increased around the world as a consequence of the TRIPS Agreement, which specifies minimum levels of intellectual
Margaret Kyle, Anita McGahan
core  

REGULATORY AND ANALYTICAL SCIENCE OF BIOSIMILARS: A PHARMACEUTICAL CHEMISTRY PERSPECTIVE

The development and approval of biosimilars represent a significant advancement in pharmaceutical science, offering cost-effective therapeutic alternatives to originator biologics. From a pharmaceutical chemistry perspective, the regulatory and analytical evaluation of biosimilars demands a rigorous, multidisciplinary approach to ensure comparable ...
openaire   +2 more sources