Abstracted Scientific Content
An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms
Author(s): Alfredo García Arieta, PhD, Clare Rodrigues
Page: 146-8
Submitted: 14 May 2021; Revised: 14 May 2021; Accepted: 3 June 2021; Published online first: 10 June 2021 Medicines regulatory authorities aim to address rising healthcare costs and promote access… Read More »
Repurposing non-oncology drugs for cancer treatment
Submitted: 15 March 2021; Revised: 17 March 2021; Accepted: 18 March 2021; Published online first: 24 March 2021 Cancer is one of the leading causes of mortality in the world… Read More »
Escalating prices of generic drugs targeted by US anti-gouging legislation
Submitted: 29 January 2019; Revised: 4 February 2019; Accepted: 5 February 2019; Published online first: 14 February 2019 Generic prescription drug prices have been escalating rapidly in the US. In… Read More »
Regulatory requirements for the acceptance of foreign comparator products in the participants of the International Generic Drug Regulators Programme
Submitted: 4 March 2019; Revised: 25 April 2019; Accepted: 27 April 2019; Published online first: 30 April 2019 The availability of quality generic drug products plays an increasingly important role… Read More »
US generic prescription drug markets 2004‒2016
Submitted: 6 December 2018; Revised: 12 December 2018; Accepted: 14 December 2018; Published online first: 19 December 2018 Generic drugs are currently central to disease treatment in the US. However,… Read More »
How does generic drug policy affect market prices?
Submitted: 21 November 2018; Revised: 22 November 2018; Accepted: 28 November 2018; Published online first: 4 December 2018 A study published by the World Health Organization (WHO) compares the effect… Read More »
EU risk-sharing agreements between 2000−2015
Submitted: 20 June 2018; Revised: 14 August 2018; Accepted: 18 August 2018; Published online first: 31 August 2018 The ageing population, longer life expectancies, and the increasing cost of drugs… Read More »
A call for coherence in EU legislation to promote generics
Submitted: 6 May 2018; Revised: 7 May 2018; Accepted: 8 May 2018; Published online first: 18 May 2018 Data and market exclusivity for originator medicines in the European Union (EU)… Read More »
Barriers to generics policy reform: a US case study
Submitted: 29 December 2017; Revised: 5 January 2018; Accepted: 12 January 2018; Published online first: 19 January 2018 A recent comparison of generic drug markets [1] explores the history of… Read More »
A comparison of European and US generic drug markets
Submitted: 19 June 2017; Revised: 5 September 2017; Accepted: 6 September 2017; Published online first: 19 September 2017 Introduction Comparative research on the European and US generic drug markets based… Read More »