Manoj Rajadhyaksha

Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study

Mette Deleuran, Diamant Thaçi, Lisa A. Beck et al. · Journal of the American Academy of Dermatology · 2019 · 256 citations · Full text

Life Sciences, Dermatology, Pharmacotherapy +13

Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis

Margitta Worm, Eric L. Simpson, Diamant Thaçi et al. · JAMA Dermatology · 2019 · 206 citations · Full text

Life Sciences, Dermatology, Pharmacotherapy +10

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Steven P. Piccoli, Devangi Mehta, Alessandra Vitaliti et al. · Bioanalysis · 2019 · 95 citations · Full text

Pharmacy, Biomedical Sciences, Biopharmaceutics +13

Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies

Zhandong Don Zhong, Adrienne Clements‐Egan, Boris Gorovits et al. · The AAPS Journal · 2017 · 84 citations · Full text

Pharmacy, Pharmaceutics, Pharmacokinetics +17

2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( <u>Part 3</u> –Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene &amp; Cell Therapy and Vaccine Assays)

Bart Corsaro, Tong‐Yuan Yang, Rocio Murphy et al. · Bioanalysis · 2021 · 61 citations · Full text

Veterinary Medicine, Biomedical Sciences, Immunology +17