Results 91 to 100 of about 10,049 (144)

Assessment of United States Food and Drug Administration Approval of Cell and Gene Therapies. [PDF]

Clin Pharmacol Ther
Shahzad M, Elsallab M, Siebert M, Bourgeois FT.   +3 more
europepmc   +1 more source

Editorial: Pharmacoepidemiology and pharmacovigilance post-marketing drug safety studies

Frontiers in Pharmacology
Zakir Khan, Yusuf Karatas, Ahmet Akici, Maria Auxiliadora Parreiras Martins, Nafees Ahmad   +4 more
doaj   +1 more source

Real-World Imaging Data: Opportunities and Challenges. [PDF]

JMIR Med Inform
Wu J, de Araujo AL, Khozin S, Huisman M, Mastrodicasa D, Willemink MJ.   +5 more
europepmc   +1 more source

Exploring variables leading to major postmarketing label changes in leading regulatory authorities: a retrospective cohort study in Israel. [PDF]

BMJ Open
Vishkautzan A, Vexberg MH, Berkovitch M, Ashkenazi S, Weiss I, Hershkowitz R, Gorelik E, Maayan H, Ainbinder D, Steinmetz Y, Berar Yanay N, Schlissel O, Shulman K, Azem M, Yarom N, Gutgold N, Divinsky M, Gatt ME, Doron A, Boochnik S, Arcavi L, Trainin M, Marom E, Uziely B, Zevin S, Barchel D, Koren R, Kariv R, Wajntraub C, Hiayev S, Luxenburg O, Ganzel C, Shacham-Shmueli E.   +32 more
europepmc   +1 more source

Association of Guillain-Barré Syndrome With Nonavalent Human Papillomavirus Vaccine: A Postmarketing Drug Safety Study. [PDF]

Obstet Gynecol Int
González Mariño MA.
europepmc   +1 more source

Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology products. [PDF]

Oncologist
Xiong Y, Konicki R, Zirkelbach JF, Bi Y, Okusanya O, Shord S, Rahman NA, Booth B, Li Y, Liu J, Zhu H.   +10 more
europepmc   +1 more source

Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016-2024. [PDF]

Clin Trials
Li LY, Ramachandran R, Ross JS, Wallach JD.   +3 more
europepmc   +1 more source

Population Pharmacokinetic Modeling and Simulation to Support the Regulatory Submission of the Two-Injection Start Regimen with Aripiprazole Once-Monthly Long-Acting Injectable Intramuscular Administration in Japanese Patients with Schizophrenia or Bipolar I Disorder. [PDF]

J Clin Pharmacol
Yamasaki Y, Sasaki T, Martinecz A, Hasegawa M, Kuwahara K, Soga A, Yamada K, Katayama S, Maeda K, Ichimura T, Kawai Y.   +10 more
europepmc   +1 more source

Ocular toxicity associated with antibody-drug conjugates in cancer therapy: a comprehensive review. [PDF]

Front Immunol
Zhou J, Wang H, Xie H, Xu X, Xiao H.
europepmc   +1 more source

From Traditional Remedy to Evidence-Based Phytotherapeutic Agent: <i>Hedera helix</i> L. in Respiratory Medicine. [PDF]

Plants (Basel)
Pawłowska AM.
europepmc   +1 more source