Literature DB >> 31552605

Comment on: "Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments".

Ravi Jandhyala1.   

Abstract

Entities:  

Year:  2019        PMID： 31552605     DOI： 10.1007/s40264-019-00862-x

Source DB:  PubMed          Journal:  Drug Saf        ISSN： 0114-5916            Impact factor:   5.606


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  3 in total

Review 1.  Observational research methods. Research design II: cohort, cross sectional, and case-control studies.

Authors:  C J Mann
Journal:  Emerg Med J       Date:  2003-01       Impact factor: 2.740

2.  Patient Registries: An Underused Resource for Medicines Evaluation : Operational proposals for increasing the use of patient registries in regulatory assessments.

Authors:  Patricia McGettigan; Carla Alonso Olmo; Kelly Plueschke; Mireia Castillon; Daniel Nogueras Zondag; Priya Bahri; Xavier Kurz; Peter G M Mol
Journal:  Drug Saf       Date:  2019-11       Impact factor: 5.606

Review 3.  Methods for the synthesis of qualitative research: a critical review.

Authors:  Elaine Barnett-Page; James Thomas
Journal:  BMC Med Res Methodol       Date:  2009-08-11       Impact factor: 4.615
  3 in total
  3 in total

1.  Authors' Reply to Ravi Jandhyala's Comment on "Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments".

Authors:  Patricia McGettigan; Carla Alonso Olmo; Kelly Plueschke; Mireia Castillon; Daniel Zondag; Priya Bahri; Xavier Kurz; Peter G M Mol
Journal:  Drug Saf       Date:  2019-12       Impact factor: 5.606

2.  The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency.

Authors:  Ravi Jandhyala
Journal:  J Pharm Policy Pract       Date:  2022-05-04

3.  The international X-linked hypophosphataemia (XLH) registry (NCT03193476): rationale for and description of an international, observational study.

Authors:  Raja Padidela; Ola Nilsson; Outi Makitie; Signe Beck-Nielsen; Gema Ariceta; Dirk Schnabel; Maria Luisa Brandi; Annemieke Boot; Elena Levtchenko; Michael Smyth; Ravi Jandhyala; Zulf Mughal
Journal:  Orphanet J Rare Dis       Date:  2020-06-30       Impact factor: 4.123
  3 in total

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