Concepedia

Lifecycle Evidence Generation

Lifecycle Evidence Generation is a systematic framework within regulatory science that orchestrates the continuous collection, analysis, and integration of clinical and real-world evidence from pre-approval development through post-market surveillance to substantiate the sustained safety and effectiveness of therapeutics approved via accelerated pathways.

10

Publications

428

Citations

55

Authors

45

Institutions

Publications per year

2017–2026

8

Parents

Publications

10

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

Sajan Khosla, Robert S. White, Jesús Medina et al. · F1000Research · 2018 · 111 citations · Full text

, , +17

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

Sajan Khosla, Robert S. White, Jesús Medina et al. · F1000Research · 2018 · 55 citations · Full text

, , +17

Designing medical technology for resilience: integrating health economics and human factors approaches

Simone Borsci, Ijeoma Uchegbu, Peter Buckle et al. · Expert Review of Medical Devices · 2017 · 51 citations

, , +17

A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions

Bruce M. Psaty, Eric M. Meslin, Alasdair Breckenridge · JAMA · 2012 · 40 citations

, , +9

What makes public health studies ethical? Dissolving the boundary between research and practice

Donald J. Willison, Nancy Ondrusek, Angus Dawson et al. · BMC Medical Ethics · 2014 · 37 citations · Full text

, , +14

1–5 of 10

Authors

55

  1. SK
    Sajan Khosla

    AstraZeneca (United Kingdom), United Kingdom

    3 publications · 192 citations

    3

    h-index

  2. GM
    Gary Male

    AstraZeneca (United States), United States

    2 publications · 166 citations

    2

    h-index

  3. CE
    Cathy Emmas

    AstraZeneca (United Kingdom), United Kingdom

    2 publications · 166 citations

    2

    h-index

  4. RS
    Robert S. White

    Cornell University, United States

    2 publications · 166 citations

    2

    h-index

  5. SL
    Sandra Leonard

    AstraZeneca (United Kingdom), United Kingdom

    2 publications · 166 citations

    2

    h-index

1–5 of 55

Institutions

45

  1. AstraZeneca (United Kingdom)

    Cambridge, United Kingdom

    3 h-index

    4 publications

    218 citations

  2. AstraZeneca (Brazil)

    São Paulo, Brazil

    2 h-index

    2 publications

    166 citations

  3. AstraZeneca (United States)

    Wilmington, United States

    2 h-index

    4 publications

    332 citations

  4. AstraZeneca (Sweden)

    Södertälje, Sweden

    2 h-index

    2 publications

    166 citations

  5. AstraZeneca (Germany)

    Wedel, Germany

    2 h-index

    2 publications

    166 citations

  6. AstraZeneca (Spain)

    Madrid, Spain

    2 h-index

    2 publications

    166 citations

  7. AstraZeneca (Japan)

    Osaka, Japan

    2 h-index

    4 publications

    332 citations

  8. Oxford Instruments (United Kingdom)

    Abingdon, United Kingdom

    2 h-index

    4 publications

    332 citations

1–8 of 45

Venues

  1. F1000Research

    2 publications · 166 citations

    2

    h-index

  2. Journal of Development Effectiveness

    1 publications · 24 citations

    1

    h-index

  3. JAMA

    1 publications · 40 citations

    1

    h-index

  4. Expert Review of Medical Devices

    1 publications · 51 citations

    1

    h-index

  5. Biologicals

    1 publications · 33 citations

    1

    h-index

1–5