Concepedia

Regulatory Filing Strategy

Regulatory Filing Strategy is a strategic framework within regulatory science that specifies the systematic approach and sequence for submitting regulatory dossiers to health authorities, distinguished by its integration of regulatory, clinical, and market access considerations to optimize approval timelines and compliance.

8

Publications

260

Citations

54

Authors

18

Institutions

Publications per year

2017–2026

5

Parents

Publications

8

Oligonucleotide Sequence Mapping of Large Therapeutic mRNAs via Parallel Ribonuclease Digestions and LC-MS/MS

Tao Jiang, Ningxi Yu, Jaeah Kim et al. · Analytical Chemistry · 2019 · 78 citations

, , +11

A comprehensive study on regulatory requirements for development and filing of generic drugs globally

Shweta Handoo, Deepak Khera, SusantaKumar Sahu et al. · International Journal of Pharmaceutical Investigation · 2012 · 69 citations · Full text

, , +17

Comparison of fluticasone furoate and fluticasone propionate for the treatment of Japanese cedar pollinosis

Kimihiro Okubo, Mitsuyoshi Nakashima, Noboru Miyake et al. · Allergy and Asthma Proceedings · 2009 · 32 citations

, , +17

Development of a Green and Sustainable Manufacturing Process for Gefapixant Citrate (MK-7264) Part 4: Formylation–Cyclization as a Flow–Batch Process Leads to Significant Improvements in Process Mass Intensity (PMI) and CO Generated versus the Batch–Batch Process

Douglas A. L. Otte, Kallol Basu, Lisa Jellett et al. · Organic Process Research & Development · 2020 · 20 citations

, , +14

Utilization of risk-based predictive stability within regulatory submissions; industry’s experience

Megan McMahon, Helen Elizabeth Williams, Elke Debie et al. · AAPS Open · 2020 · 20 citations · Full text

, , +11

1–5 of 8

Authors

54

  1. KO
    Kimihiro Okubo

    Nippon Medical School, Japan

    1 publications · 32 citations

    1

    h-index

  2. RB
    Robert Bujalski

    University of Alberta, Canada

    1 publications · 20 citations

    1

    h-index

  3. NY
    Ningxi Yu

    University of Cincinnati, United States

    1 publications · 78 citations

    1

    h-index

  4. JN
    Jarod Nappi

    Merck & Co., Inc., Rahway, NJ, USA (United States), United States

    1 publications · 20 citations

    1

    h-index

  5. DD
    David Donoghue

    Merck & Co., Inc., Rahway, NJ, USA (United States), United States

    1 publications · 20 citations

    1

    h-index

1–5 of 54

Institutions

18

  1. Merck & Co., Inc., Rahway, NJ, USA (United States)

    Rahway, United States

    2 h-index

    14 publications

    280 citations

  2. Pfizer (United States)

    New York, United States

    2 h-index

    7 publications

    116 citations

  3. Jubilant Life Sciences (India)

    Noida, India

    1 h-index

    3 publications

    207 citations

  4. Nippon Medical School

    Tokyo, Japan

    1 h-index

    1 publications

    32 citations

  5. Eli Lilly (United States)

    Indianapolis, United States

    1 h-index

    1 publications

    20 citations

  6. Utkal University

    Bhubaneswar, India

    1 h-index

    1 publications

    69 citations

  7. Biogen (United States)

    Cambridge, United States

    1 h-index

    1 publications

    20 citations

  8. University of Technology and Management

    Shillong, India

    1 h-index

    2 publications

    138 citations

1–8 of 18

Venues

  1. Organic Process Research & Development

    2 publications · 36 citations

    2

    h-index

  2. AAPS Open

    1 publications · 20 citations

    2

    h-index

  3. 1

    h-index

  4. 1

    h-index

  5. Allergy and Asthma Proceedings

    1 publications · 32 citations

    1

    h-index

1–5