Zobrazeno 1 - 7
of 7
pro vyhledávání: '"Daiva Shetty"'
Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies
Autor:
Lewis J. Fermaglich, Johnny Young, Eunjung Esther Chuh, Ru Chen, Julia Lee, Carol Y. Kim, Daiva Shetty, Teena Thomas, Ying Fan
Publikováno v:
Therapeutic innovationregulatory science. 53(1)
The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications (ANDAs) with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion (I/S/A) stud
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::11678c7bb6742766d421e45f09e91046
https://pubmed.ncbi.nlm.nih.gov/29719976
https://pubmed.ncbi.nlm.nih.gov/29719976
Autor:
Lesley-Anne Furlong, Elena Braithwaite, Daiva Shetty, James Osterhout, Sree Rayavarapu, John R. Peters, Robert T. Dorsam
Publikováno v:
Toxicological sciences : an official journal of the Society of Toxicology. 146(1)
This review highlights general toxicology concerns caused by formulation differences between generic and innovator drugs. It underscores the importance of a scientific, clinically oriented, evidence-based comparative safety evaluation procedure for g
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2039c0382f02162036b52f0c15cce23d
https://pubmed.ncbi.nlm.nih.gov/26101235
https://pubmed.ncbi.nlm.nih.gov/26101235
Autor:
John Bacher, Stephen C. Piscitelli, Neelam Giri, Erwin Feuerstein, Daiva Shetty, Corina E. Gonzalez, Andreas H. Groll, Ibrahim Al-Mohsen, Tin Sein, Thomas J. Walsh
Publikováno v:
Antimicrobial Agents and Chemotherapy. 42:2399-2404
The activity of the pradimicin derivative BMS 181184 was evaluated in a model of invasive pulmonary aspergillosis in persistently neutropenic rabbits and compared with that of amphotericin B deoxycholate. BMS 181184 at total daily doses of 50 and 150
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c39bfca670a2f93afb3421fff7120aa8
https://doi.org/10.1128/aac.42.9.2399
https://doi.org/10.1128/aac.42.9.2399
Publikováno v:
The Pediatric Infectious Disease Journal. 16:216-221
Background. Aspergillosis is an uncommon yet serious opportunistic infection in patients with AIDS. It has been extensively reported in HIV-infected adult patients. To our knowledge there are no studies that describe the epidemiology, clinical manife
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7a36e721741f2676ec93e2a5bc709d3f
https://doi.org/10.1097/00006454-199702000-00010
https://doi.org/10.1097/00006454-199702000-00010
Publikováno v:
Journal of the American Pharmacists Association : JAPhA. 49(5)
Objective To inform the health care community about nonprescription drug labeling and consumer studies unique and integral to the nonprescription drug development process. Summary Data from consumer studies are essential for many nonprescription drug
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::33bd5e08a3371afdac0f3891e2fa82cb
https://pubmed.ncbi.nlm.nih.gov/19748876
https://pubmed.ncbi.nlm.nih.gov/19748876
Autor:
Corina E. Gonzalez, Thomas J. Walsh, Linda L. Lewis, Brigitta U. Mueller, Daiva Shetty, Philip A. Pizzo
Publikováno v:
The Pediatric infectious disease journal. 15(9)
Cryptococcosis is a common opportunistic infection in adults with AIDS. Few cases of cryptococcosis complicating pediatric AIDS have been reported. To our knowledge there are no studies that describe the epidemiology, clinical manifestations and outc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8438e38a921a493f6d00d1eb490e7b7b
https://pubmed.ncbi.nlm.nih.gov/9154559
https://pubmed.ncbi.nlm.nih.gov/9154559
Autor:
Joanne Peter, Emmanuel Roilides, Daiva Shetty, Corina E. Gonzalez, Helen Katsifa, Thomas J. Walsh, Caron A. Lyman
Publikováno v:
International Journal of Infectious Diseases. 6:S49
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2d67e8075337372fcc85ced485510245
https://doi.org/10.1016/s1201-9712(02)90282-1
https://doi.org/10.1016/s1201-9712(02)90282-1