Regulatory Toxicology and Pharmacology

1

Suspected herbal hepatotoxicity: The pharmacovigilance dilemma with disputed and obsolete evaluation methods

Teschke, Rolf, Frenzel, Christian, Schulze, Johannes, Eickhoff, Axel

Journal:

Year:

2012

Language:

english

File:

PDF, 138 KB

english, 2012

2

Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: Was causality adequately ascertained?

Stammschulte, Thomas, Gundert-Remy, Ursula

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 129 KB

english, 2012

3

An updated inhalation unit risk factor for arsenic and inorganic arsenic compounds based on a combined analysis of epidemiology studies

Erraguntla, Neeraja K., Sielken, Robert L., Valdez-Flores, Ciriaco, Grant, Roberta L.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 292 KB

english, 2012

4

Asbestos exposure from the overhaul of a Pratt & Whitney R2800 engine

Mlynarek, S.P., Van Orden, D.R.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 383 KB

english, 2012

5

Cancer mode of action, weight of evidence, and proposed cancer reference value for hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)

Sweeney, Lisa M., Okolica, Michelle R., Gut, Chester P., Gargas, Michael L.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 574 KB

english, 2012

6

Arsenic exposure and tobacco consumption: Biomarkers and risk assessment

Marano, Kristin M., Naufal, Ziad S., Kathman, Steven J., Bodnar, Joy A., Borgerding, Michael F., Wilson, Cody L.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 489 KB

english, 2012

7

Cadmium exposure and tobacco consumption: Biomarkers and risk assessment

Marano, Kristin M., Naufal, Ziad S., Kathman, Steven J., Bodnar, Joy A., Borgerding, Michael F., Garner, Charles D., Wilson, Cody L.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 561 KB

english, 2012

8

Application of scientific criteria to food allergens of public health importance

Chung, Y.J., Ronsmans, S., Crevel, R.W.R., Houben, G.F., Rona, R.J., Ward, R., Baka, A.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 392 KB

english, 2012

9

A four-week repeated study of intravenous toxicity of recombinant human interleukin-2 in Sprague–Dawley rats

Lee, Mi Ju, Park, Sun Hee, Kim, Myoung Jun, Kim, Hye-Jin, Li, Yinghua, Ko, Kyeoung-Nam, Kim, Duyeol, Lee, Yong-Hoon, Kim, Sun-Hee, Jang, Ho-Song, Baik, Yeongjun, Lee, Sunghee, Kang, Jin Seok, Kang, Jo

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 1.34 MB

english, 2012

10

13-Week oral toxicity study of oil derived from squid (Todarodes pacificus) in Sprague-Dawley rats

Park, Joung-Hyun, Musa-Veloso, Kathy, Lynch, Barry, Leslie, Heather, Koo, Kyo-Hwan, Kim, Seon-Bong, Kang, Suk-Nam

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 259 KB

english, 2012

11

Comparison of bioequivalence study regulatory requirements for human and veterinary drugs

Grabowski, Tomasz, Marczak, Monika, Jaroszewski, Jerzy Jan, Whitmire, Monica

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 299 KB

english, 2012

12

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 5: 8-Day randomized clinical trial in Japan

Tricker, Anthony R., Kanada, Shigeto, Takada, Kohji, Leroy, Claire Martin, Lindner, Dirk, Schorp, Matthias K., Dempsey, Ruth

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 363 KB

english, 2012

13

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 2: Smoke chemistry and in vitro toxicological evaluation using smoking regimens reflecting human puffing behavior

Zenzen, Volker, Diekmann, Joerg, Gerstenberg, Birgit, Weber, Susanne, Wittke, Sandra, Schorp, Matthias K.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 1.05 MB

english, 2012

14

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 8: Nicotine bridging – Estimating smoke constituent exposure by their relationships to both nicotine levels in mainstream cigarette smoke and in smokers

Urban, H.-Jörg, Tricker, Anthony R., Leyden, Donald E., Forte, Natasa, Zenzen, Volker, Feuersenger, Astrid, Assink, Mareike, Kallischnigg, Gerd, Schorp, Matthias K.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 1.22 MB

english, 2012

15

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 7: A one-month, randomized, ambulatory, controlled clinical study in Poland

Martin Leroy, Claire, Jarus-Dziedzic, Katarzyna, Ancerewicz, Jacek, Lindner, Dirk, Kulesza, Agnieszka, Magnette, John

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 365 KB

english, 2012

16

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 6: 6-day randomized clinical trial of a menthol cigarette in Japan

Tricker, Anthony R., Kanada, Shigeto, Takada, Kohji, Martin Leroy, Claire, Lindner, Dirk, Schorp, Matthias K., Dempsey, Ruth

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 374 KB

english, 2012

17

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 1: Non-clinical and clinical insights

Schorp, Matthias K., Tricker, Anthony R., Dempsey, Ruth

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 424 KB

english, 2012

18

Nanoparticle iron medicinal products – Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies

Borchard, Gerrit, Flühmann, Beat, Mühlebach, Stefan

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 339 KB

english, 2012

19

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 3: Eight-day randomized clinical trial in the UK

Tricker, Anthony R., Stewart, Adrian J., Leroy, Claire Martin, Lindner, Dirk, Schorp, Matthias K., Dempsey, Ruth

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 668 KB

english, 2012

20

Establishing a total allowable concentration of o-toluidine in drinking water incorporating early lifestage exposure and susceptibility

Caroline English, J., Bhat, Virunya S., Ball, Gwendolyn L., McLellan, Clifton J.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 522 KB

english, 2012

21

Implications of estimates of residential organophosphate exposure from dialkylphosphates (DAPs) and their relevance to risk

Krieger, R.I., Chen, L., Ginevan, M., Watkins, D., Cochran, R.C., Driver, J.H., Ross, J.H.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 177 KB

english, 2012

22

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 4: Eight-day randomized clinical trial in Korea

Tricker, Anthony R., Jang, In-Jin, Martin Leroy, Claire, Lindner, Dirk, Dempsey, Ruth

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 325 KB

english, 2012

23

Corrigendum to ‘‘Putting the parts together: Combining in vitro methods to test for skin sensitizing potentials” [Regul. Toxicol. Pharmacol. 63 (2012) 489–504]

Bauch, Caroline, Kolle, Susanne N., Ramirez, Tzutzuy, Eltze, Tobias, Fabian, Eric, Mehling, Annette, Teubner, Wera, van Ravenzwaay, Bennard, Landsiedel, Robert

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 121 KB

english, 2012

24

What is a food and what is a medicinal product in the European Union? Use of the benchmark dose (BMD) methodology to define a threshold for “pharmacological action”

Lachenmeier, Dirk W., Steffen, Christian, el-Atma, Oliver, Maixner, Sibylle, Löbell-Behrends, Sigrid, Kohl-Himmelseher, Matthias

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 477 KB

english, 2012

25

NEPA, EPA and risk assessment: Has EPA lost its way?

Calabrese, Edward J.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 132 KB

english, 2012

26

Alkaline earth silicate wools – A new generation of high temperature insulation

Brown, Robert C., Harrison, Paul T.C.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 269 KB

english, 2012

27

An assessment of the skin sensitisation hazard of a group of polyfunctional silicones using a weight of evidence approach

Petry, Thomas, Bosch, Axel, Coste, Xavier, Dupuis, Valérie, Eigler, Dorothea, Germain, Pierre

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 677 KB

english, 2012

28

Cover 2–Editorial Board

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 31 KB

english, 2012

29

Cover 2–Editorial Board

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 31 KB

english, 2012

31

Volume 64; Issue 2

Regulatory Toxicology and Pharmacology

Suspected herbal hepatotoxicity: The pharmacovigilance dilemma with disputed and obsolete evaluation methods

Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: Was causality adequately ascertained?

An updated inhalation unit risk factor for arsenic and inorganic arsenic compounds based on a combined analysis of epidemiology studies

Asbestos exposure from the overhaul of a Pratt & Whitney R2800 engine

Cancer mode of action, weight of evidence, and proposed cancer reference value for hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)

Arsenic exposure and tobacco consumption: Biomarkers and risk assessment

Cadmium exposure and tobacco consumption: Biomarkers and risk assessment

Application of scientific criteria to food allergens of public health importance

A four-week repeated study of intravenous toxicity of recombinant human interleukin-2 in Sprague–Dawley rats

13-Week oral toxicity study of oil derived from squid (Todarodes pacificus) in Sprague-Dawley rats

Comparison of bioequivalence study regulatory requirements for human and veterinary drugs

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 5: 8-Day randomized clinical trial in Japan

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 2: Smoke chemistry and in vitro toxicological evaluation using smoking regimens reflecting human puffing behavior

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 8: Nicotine bridging – Estimating smoke constituent exposure by their relationships to both nicotine levels in mainstream cigarette smoke and in smokers

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 7: A one-month, randomized, ambulatory, controlled clinical study in Poland

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 6: 6-day randomized clinical trial of a menthol cigarette in Japan

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 1: Non-clinical and clinical insights

Nanoparticle iron medicinal products – Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 3: Eight-day randomized clinical trial in the UK

Establishing a total allowable concentration of o-toluidine in drinking water incorporating early lifestage exposure and susceptibility

Implications of estimates of residential organophosphate exposure from dialkylphosphates (DAPs) and their relevance to risk

Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 4: Eight-day randomized clinical trial in Korea

Corrigendum to ‘‘Putting the parts together: Combining in vitro methods to test for skin sensitizing potentials” [Regul. Toxicol. Pharmacol. 63 (2012) 489–504]

What is a food and what is a medicinal product in the European Union? Use of the benchmark dose (BMD) methodology to define a threshold for “pharmacological action”

NEPA, EPA and risk assessment: Has EPA lost its way?

Alkaline earth silicate wools – A new generation of high temperature insulation

An assessment of the skin sensitisation hazard of a group of polyfunctional silicones using a weight of evidence approach

Cover 2–Editorial Board

Table of Contents

Cover 2–Editorial Board

Table of Contents