Volume 94

Regulatory Toxicology and Pharmacology

Volume 94

1

An evaluation of the fixed concentration procedure for assessment of acute inhalation toxicity

Sewell, Fiona, Ragan, Ian, Indans, Ian, Marczylo, Tim, Stallard, Nigel, Griffiths, David, Holmes, Thomas, Smith, Paul, Horgan, Graham

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 1.05 MB

english, 2018

2

Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing

Ulrich, Peter, Blaich, Guenter, Baumann, Andreas, Fagg, Rajni, Hey, Adam, Kiessling, Andrea, Kronenberg, Sven, Lindecrona, Rikke Hvid, Mohl, Silke, Richter, Wolfgang F., Tibbitts, Jay, Crameri, Flavio

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 365 KB

english, 2018

3

Toxicity assessment of the extractables from multi-layer coextrusion poly ethylene bags exposed to pH=5 solution containing 4% benzyl alcohol and 0.1 M sodium acetate

Zhuang, Jingcong, Xing, Xuebin, Wang, Di, Du, Zhenxia, Wang, Jianfeng, Dong, Yan, Yu, Wenlian, Siyal, Sajid Hussain

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 1.03 MB

english, 2018

4

Food and feed safety of DAS-444Ø6-6 herbicide-tolerant soybean

Herman, Rod A., Ekmay, Ricardo D., Schafer, Barry W., Song, Ping, Fast, Brandon J., Papineni, Sabitha, Shan, Guomin, Juberg, Daland R.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 238 KB

english, 2018

5

Repeated dose 28-day oral toxicity study of a botanical composition composed of Morus alba and Acacia catechu in rats

Yimam, Mesfin, Jiao, Ping, Hong, Mei, Brownell, Lidia, Hyun-Jin Kim,, Lee, Young-Chul, Jia, Qi

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 378 KB

english, 2018

6

Status of acute systemic toxicity testing requirements and data uses by U.S. regulatory agencies

Strickland, Judy, Clippinger, Amy J., Brown, Jeffrey, Allen, David, Jacobs, Abigail, Matheson, Joanna, Lowit, Anna, Reinke, Emily N., Johnson, Mark S., Quinn, Michael J., Mattie, David, Fitzpatrick, S

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 355 KB

english, 2018

7

Interplay of gender, age and drug properties on reporting frequency of drug-induced liver injury

George, Nayana, Chen, Minjun, Yuen, Nancy, Hunt, Christine M., Suzuki, Ayako

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 769 KB

english, 2018

8

A comparison of fish pesticide metabolic pathways with those of the rat and goat

Kolanczyk, Richard C., Serrano, Jose A., Tapper, Mark A., Schmieder, Patricia K.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 3.09 MB

english, 2018

9

Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides

Bercu, J.P., Galloway, S.M., Parris, P., Teasdale, A., Masuda-Herrera, M., Dobo, K., Heard, P., Kenyon, M., Nicolette, J., Vock, E., Ku, W., Harvey, J., White, A., Glowienke, S., Martin, E.A., Custer,

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 314 KB

english, 2018

10

Biomonitoring Equivalents for interpretation of urinary iodine

Hays, Sean M., Poddalgoda, Devika, Macey, Kristin, Aylward, Lesa, Nong, Andy

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 299 KB

english, 2018

11

Toxicological evaluation of 3′-sialyllactose sodium salt

Kim, Daehee, Gurung, Rit Bahadur, Seo, Wonmin, Lee, Albert W., Woo, Jinsuk

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 271 KB

english, 2018

12

Developmental immunotoxicity is not associated with the consumption of transgenic Bt rice TT51 in rats

Hu, Jing, Liang, Chunlai, Zhang, Xiaopeng, Zhang, Qiannan, Cui, Wenming, Yu, Zhou

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 338 KB

english, 2018

13

Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review

Scherer, Gerhard

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 978 KB

english, 2018

14

A kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrates no evidence of a health risk from developmental toxicity

Labib, R., Bury, D., Boisleve, F., Eichenbaum, G., Girard, S., Naciff, J., Leal, M., Wong, J.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 1.52 MB

english, 2018

15

Assessing the safety of an Ephedrae Herba aqueous extract in rats: A repeat dose toxicity study

Han, Hyoung-Yun, Huh, Jung-Im, Han, So-Ri, Kang, Myung-Gyun, Yoon, Seokjoo, Han, Ji-Seok, Lee, Byoung-Seok, Kim, Jeong Ah, Min, Byung-Sun

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 699 KB

english, 2018

16

Mixture risk assessment of selected mainstream cigarette smoke constituents generated from low-yield cigarettes in South Korean smokers

Pack, Eun Chul, Jang, Dae Yong, Kim, Hyung Soo, Lee, Seung Ha, Kim, Hae Young, Song, Seok Ho, Cho, Hoon Sik, Kwon, Kyeng Hee, Park, Kun Ho, Lim, Kyung Min, Choi, Dal Woong

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 820 KB

english, 2018

17

Survival of Escherichia coli harboring nucleic acid-hydrolyzing 3D8 scFv during RNA virus infection

Park, Jung-Ho, Lee, Jae-Woo, Choi, Hoonsung, Jung, Sun Keun, Kim, Jeom Sun, Kim, Kyung-Woon, Oh, Keon Bong, Yang, Hyeon, Byun, Sung June

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 1.31 MB

english, 2018

18

Mechanism-informed read-across assessment of skin sensitizers based on SkinSensDB

Tung, Chun-Wei, Wang, Chia-Chi, Wang, Shan-Shan

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 640 KB

english, 2018

19

Providing context for phosphatidylethanol as a biomarker of alcohol consumption with a pharmacokinetic model

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 901 KB

english, 2018

20

Impact of exposure factor selection on deterministic consumer exposure assessment

Ban, Hyunkyung, Park, Ji Young, Lee, Daeyeop, Lee, Kiyoung

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 296 KB

english, 2018

21

Allergenic sensitization versus elicitation risk criteria for novel food proteins

Herman, Rod A., Ladics, Gregory S.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 150 KB

english, 2018

22

Nonclinical evaluation of immunological safety in Göttingen Minipigs: The CONFIRM initiative

Descotes, Jacques, Allais, Linda, Ancian, Philippe, Pedersen, Henrik Duelund, Friry-Santini, Claire, Iglesias, Antonio, Rubic-Schneider, Tina, Skaggs, Hollie, Vestbjerg, Peter

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 197 KB

english, 2018

23

Response to Letter to the Editor on our paper “Evaluation of radioisotopic and non-radioisotopic versions of local lymph node assays for subcategorization of skin sensitizers compliant to UN GHS rev 4” by Ha et al. (Submitted 25 Jun 2017)

Kyung-Min, Lim, Bae, SeungJin

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

Language:

english

File:

PDF, 1.25 MB

english, 2018

24

Editorial Board

Journal:

Regulatory Toxicology and Pharmacology

Year:

2018

File:

PDF, 37 KB

2018