Zobrazeno 1 - 10
of 21
pro vyhledávání: '"Bruce D. Naumann"'
Autor:
Bruce D Naumann, Susan Arnold
Publikováno v:
Toxicology and Industrial Health. 35:614-625
Guidance for managing potential dermal exposures has historically been qualitative in nature, for example, in the form of a DSEN notation. We propose a method that can provide quantitative guidance on how to establish and use surface wipe limits for
Autor:
Qingyu Meng, Mark G. Robson, Edward V. Sargent, Jun Yan Hong, Bruce D. Naumann, Jessica Vestel
Publikováno v:
Human and Ecological Risk Assessment: An International Journal. 23:879-894
The presence of synthetic glucocorticosteroids (GCs) in surface water and their potential endocrine disruption (ED) activity at environmental concentrations has not been fully investigated. Synthetic GCs may interfere with endogenous receptors within
Autor:
Robert G. Sussman, Ester Lovsin Barle, Eileen P. Hayes, Alison M. Pecquet, Lance R. Molnar, Bruce D. Naumann, Patricia A. Weideman, Bryan K. Shipp, Michael J. Olson, Robert A. Jolly, Ellen C. Faria
Publikováno v:
Regulatory Toxicology and Pharmacology. 79:S19-S27
This manuscript centers on communication with key stakeholders of the concepts and program goals involved in the application of health-based pharmaceutical cleaning limits. Implementation of health-based cleaning limits, as distinct from other standa
Autor:
Lance R. Molnar, Ellen C. Faria, Ester Lovsin Barle, Joel P. Bercu, Alison M. Pecquet, Michael J. Olson, Bryan K. Shipp, Robert G. Sussman, Robert A. Jolly, Bruce D. Naumann, Reena Sandhu, Eileen P. Hayes, Patricia A. Weideman
Publikováno v:
Regulatory Toxicology and Pharmacology. 79:S39-S47
A European Union (EU) regulatory guideline came into effect for all new pharmaceutical products on June 1st, 2015, and for all existing pharmaceutical products on December 1st, 2015. This guideline centers around the use of the Acceptable Daily Expos
Autor:
Robert G. Sussman, Tracy A. Kimmel, Allan W. Ader, Bruce D. Naumann, Patricia A. Weideman, Anthony R. Schatz
Publikováno v:
Regulatory Toxicology and Pharmacology. 79:S11-S18
Historically, pharmaceutical industry regulatory guidelines have assigned certain active pharmaceutical ingredients (APIs) to various categories of concern, such as “cytotoxic”, “hormones”, and “steroids”. These categories have been used
Autor:
Anthony J. Streeter, John F. Reichard, Alison M. Pecquet, Reena Sandhu, Bruce D. Naumann, M. Andrew Maier, Patricia A. Weideman, Thomas Pfister, Edward V. Sargent
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 79
The purpose of this paper is to describe the use of toxicokinetic (TK) and toxicodynamic (TD) data in setting acceptable daily exposure (ADE) values and occupational exposure limits (OELs). Use of TK data can provide a more robust exposure limit base
Autor:
Christopher Seaman, Patricia A. Weideman, Robert G. Sussman, Claudia Sehner, Thomas Pfister, Bruce D. Naumann
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 79
Acceptable daily exposures (ADEs) are established to determine the quantity of one drug substance that can contaminate another drug product without causing harm to the patient. An important part in setting an ADE for a drug substance, after identific
Publikováno v:
Journal of Occupational and Environmental Hygiene
The uncertainty factor concept is integrated into health risk assessments for all aspects of public health practice, including by most organizations that derive occupational exposure limits. The use of uncertainty factors is predicated on the assumpt
Publikováno v:
Regulatory Toxicology and Pharmacology. 43:1-9
A scientific rationale is provided for estimating acceptable daily intake values (ADIs) for compounds with limited or no toxicity information to support pharmaceutical manufacturing operations. These ADIs are based on application of the "thresholds o
Publikováno v:
Human and Ecological Risk Assessment: An International Journal. 10:99-111
Timolol maleate is a non-selective beta-adrenergic blocking agent currently used primarily to reduce intraocular pressure in the treatment of glaucoma. It also produces effects on the heart and bronchial smooth muscle and all of these effects are of