Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and …

T Gronde, CA Uyl-de Groot, T Pieters - PloS one, 2017 - journals.plos.org
Context Recent public outcry has highlighted the rising cost of prescription drugs worldwide,
which in several disease areas outpaces other health care expenditures and results in a …

[HTML][HTML] Developing new immunosuppression for the next generation of transplant recipients: the path forward

MD Stegall, RE Morris, RR Alloway… - American Journal of …, 2016 - Elsevier
The development of new immunosuppressive drugs has slowed markedly over the past
several years, and the outlook that improved therapy will be available to the next generation …

A comprehensive CHO SWATH-MS spectral library for robust quantitative profiling of 10,000 proteins

KH Sim, LCY Liu, HT Tan, K Tan, D Ng, W Zhang… - Scientific Data, 2020 - nature.com
Sequential window acquisition of all theoretical fragment-ion spectra (SWATH) is a data-
independent acquisition (DIA) strategy that requires a specific spectral library to generate …

Chromatography assisted in-vitro refolding and purification of recombinant peptibody: Recombinant Romiplostim a case study

S Rana, S Ughade, R Kumthekar… - International Journal of …, 2023 - Elsevier
In-vitro protein refolding is one of the key rate-limiting unit operations in manufacturing of
fusion proteins such as peptibodies expressed using E. coli. Dilution-assisted refolding is …

A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs

MJ Zeukeng, E Seoane-Vazquez… - European journal of clinical …, 2018 - Springer
Introduction This study compared the characteristics of new human drugs approved by the
Food and Drug Administration (FDA), the European Medicine Agency (EMA), and …

Accessibility of cancer drugs in Switzerland: time from approval to pricing decision between 2009 and 2018

KN Vokinger, UJ Muehlematter - Health Policy, 2020 - Elsevier
Background Approved drugs must be included on the so-called “special list”(SL) by the
Federal Office for Public Health (FOPH) to be reimbursed by the social health insurance in …

The EU Clinical Trials Regulation: key priorities, purposes and aims and the implications for public health

ML Flear - Journal of Medical Ethics, 2016 - jme.bmj.com
The replacement of the European Union (EU) Clinical Trials Directive by the new Clinical
Trials Regulation (CTR), which entered into force on 16 June 2014 but will not apply before …

[PDF][PDF] Drug review differences across the United States and the European Union

MM Sifuentes, A Giuffrida - Pharmaceut Reg Affairs, 2015 - researchgate.net
Given the globalization of the pharmaceutical industry, harmonizing the drug regulatory
environment of the United States (US) and European Union (EU) is becoming increasingly …

Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs

KN Vokinger, AS Kesselheim - Health Policy, 2019 - Elsevier
Background Successful first-generation drugs can be converted with small alterations to"
second-generation drugs," which are cheaper to develop and may pose less financial risk …

[图书][B] The Future of Pharmaceuticals: A Nonlinear Analysis

SK Niazi - 2022 - taylorfrancis.com
Before now, biological systems could only be expressed in terms of linear relationships,
however, as knowledge grows and new techniques of analysis on biological systems is …