Zobrazeno 1 - 10
of 22
pro vyhledávání: '"Anne M Wolka"'
Publikováno v:
Therapeutic Innovation & Regulatory Science. 50:342-346
In 2012, the International Conference on Harmonisation (ICH) E2C (R1) guideline for periodic safety update reporting (PSUR) for medicines was revised. Several new concepts that expanded the scope of the report were added, including a new section focu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6a10266d7eb4ce20c239621510b78107
https://doi.org/10.1177/2168479015609650
https://doi.org/10.1177/2168479015609650
Publikováno v:
Pharmaceutical Medicine. 30:79-85
Late-stage attrition of pharmaceutical products has downsides for both patients participating in clinical trials and sponsor companies. This manuscript presents an outline for a structured qualitative benefit-risk assessment process that sponsors can
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7321194aec29932fc1cee65f450ee87f
https://doi.org/10.1007/s40290-015-0132-4
https://doi.org/10.1007/s40290-015-0132-4
Autor:
Anne M. Wolka, Christine Radawski, Kristin Bullok, JuAn Wang, Rebecca Noel, Margaret R. Warner
Publikováno v:
Therapeutic innovationregulatory science. 50(1)
The main responsibility of regulators and industry is to ensure the benefit-risk balance of pharmaceutical products is positive for the intended patient populations. In recent decades, regulators and industry have taken steps to systematize benefit-r
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d4fb5b33a192cc1854072749fddb61ee
https://pubmed.ncbi.nlm.nih.gov/30236009
https://pubmed.ncbi.nlm.nih.gov/30236009
Autor:
Rebecca Noel, Anne M. Wolka, F. Reed Johnson, Debra L. Michaels, Marilyn Metcalf, Meredith Smith, Tarek A. Hammad, Bennett Levitan
Publikováno v:
Therapeutic innovationregulatory science. 50(5)
Benefit-risk assessment is the foundation for decision making throughout the life cycle of medical products. Because patients are the beneficiaries of the efficacy of medical treatments and also bear their possible risks, their perspectives and judgm
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b39fc4adb50f56e06febd73f1b38fb5e
https://pubmed.ncbi.nlm.nih.gov/30231755
https://pubmed.ncbi.nlm.nih.gov/30231755
Publikováno v:
Therapeutic innovationregulatory science. 50(6)
A recent publication from Eli Lilly and Company provided guidance on incorporation of a structured benefit-risk assessment framework into Section 2.5.6 of the Clinical Overview of marketing authorization applications. Because a template alone cannot
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3c145b5a94bd03e6dc02918db602d75f
https://pubmed.ncbi.nlm.nih.gov/30231743
https://pubmed.ncbi.nlm.nih.gov/30231743
Publikováno v:
Therapeutic innovationregulatory science. 49(3)
Background: The complexity of drug risk information often exceeds patients’ abilities to understand and effectively act on it. Methods: The authors evaluated a layperson-focused European Union Risk Management Plan Public Summary and revised it to i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eec65be1e2ac319d3d27bec426ad2c5e
https://pubmed.ncbi.nlm.nih.gov/30222406
https://pubmed.ncbi.nlm.nih.gov/30222406
Autor:
Anne M. Wolka, Shelby D. Reed, Michael Siegel, F. Reed Johnson, Greg Anglin, Angelyn O. Fairchild, Rebecca Noel
Publikováno v:
Therapeutic innovationregulatory science. 52(4)
Formal incorporation of patients' perspectives is becoming increasingly important in medical product development and decision making. This article shares practical advice regarding how patient advocacy organizations, the pharmaceutical industry, and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b95973abcd55fbc7dd23e298b00c62b7
https://pubmed.ncbi.nlm.nih.gov/29714550
https://pubmed.ncbi.nlm.nih.gov/29714550
Autor:
Jose G. González, Melanie Chan, Markolf Hanefeld, Anne M. Wolka, Marilyn K. Boardman, David Russell-Jones, Robert M. Cuddihy, Ajay Kumar
Publikováno v:
Diabetes Care
OBJECTIVE To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes. RE
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2283ece58fea5fe9067b30e8894ae2fe
https://doi.org/10.2337/dc11-1107
https://doi.org/10.2337/dc11-1107
Autor:
Lloyd Paul, Aiello, Louis, Vignati, Matthew J, Sheetz, Xin, Zhi, Aniz, Girach, Matthew D, Davis, Anne M, Wolka, Nazila, Shahri, Roy C, Milton, Lucy H Y, Young
Publikováno v:
Retina. 31:2084-2094
To evaluate efficacy, safety, and causes of vision loss among 813 patients (1,392 eyes) with moderately severe to very severe nonproliferative diabetic retinopathy from the Protein Kinase C β Inhibitor-Diabetic Retinopathy Study and Protein Kinase C
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fd5049640a59ab38df642dce4202c202
https://doi.org/10.1097/iae.0b013e3182111669
https://doi.org/10.1097/iae.0b013e3182111669
Autor:
Vladimir Kopernicky, Steven Watts, Sidney Glina, Ignacio Moncada, Gerald B. Brock, Anne M. Wolka, Lei Xu
Publikováno v:
Urology. 73:756-761
OBJECTIVES To identify the patient demographic factors, comorbidities, and concomitant medications associated with a change in the likelihood of tadalafil-associated adverse events (AEs) in men with erectile dysfunction. METHODS Pooled safety data we
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9bf8f2e06b2e96250cdac0baa1e49c14
https://doi.org/10.1016/j.urology.2008.10.058
https://doi.org/10.1016/j.urology.2008.10.058