Stagewise, group sequential experimental designs for quantal responses. One-sample and two-sample comparisons

Feder, Paul I.; Olson, Carl; Hobson, David W.; Matthews, Monte; Joiner, R.L.

doi:10.1016/s0149-7634(05)80104-6

Cited by 29 publications

(20 citation statements)

References 5 publications

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“…Based upon the results of the SSWP, a 14-day oral toxicity study will be performed to determine the effects of repeated daily dosing with either sodium or potassium periodate. The acute toxicity of sodium periodate and potassium periodate will be assessed using the SSWP method (Feder et al, 1991a, Feder et al, 1991b. This method proceeds in stages in which groups of rats are dosed and the responses observed and used in determining the doses and animal numbers used in the next stage of dosing.…”

Section: Methodsmentioning

confidence: 99%

“…Experimental data generated during the course of this study were recorded by hand and tabulated, summarized, and/or statistically analyzed using Data from the SSWP were analyzed according to the methods of Feder et al (Feder et al, 1991a;Feder et al, 1991b) to determine the LD 50 , 95% confidence interval, and slope of the dose response curve. The ALD was determined as the lowest dose which was lethal where two successively higher doses were lethal and three lower doses were not lethal.…”

Section: Data Collection and Statistical Analysesmentioning

confidence: 99%

“…The acute toxicity of sodium periodate and potassium periodate was assessed using the Sequential Stage-Wise Probit (SSWP) method Feder et al, 1991a;Feder et al, 1991b). This method proceeds in rounds in which groups of rats are dosed and the responses observed and used in determining the doses and number of animal used in the next round of dosing.…”

Section: Acute Studymentioning

confidence: 99%

“…Personnel and the procedures they perform will be documented at the time of necropsy. Data from the SSWP will be analyzed according to the methods of Feder et al (Feder et al, 1991a, Feder et al, 1991b to determine the LD 50 , 95% confidence interval, and slope of the dose response curve. The ALD, as determined in section V.1.1., will be compared to the LD 50 from the SSWP to estimate, if necessary, an adjustment factor between fasted and fed rats for use in determining doses for the subacute study.…”

Section: V123 Body Weight and Food Consumptionmentioning

confidence: 99%

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Acute and Subacute Oral Toxicity of Periodate in Rats

Lent¹,

Crouse²

2014

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Subacute administration of sodium periodate via oral gavage resulted in a cascade of effects that were secondary to kidney toxicity. Decreased mass of ovaries and epididymides and testicular degeneration were observed in sodium periodate groups with signs of kidney toxicity. These groups also exhibited decreased T3 and T4 in the presence of decreased TSH, a pattern associated with uremia. Sodium periodate exposed rats exhibited both activation of the innate immune system and lymphocyte depletion; however, the pattern of effects was more indicative of a stress leukogram. Effects on the thymus and spleen in the absence of adrenal hyperplasia suggest more direct effects on the immune system. Decreased body mass observed in high dose groups was associated with gross and histopathologic findings in the gastrointestinal tract and may be related to effects on absorption. Increased cholesterol was identified as the critical endpoint and was used to derive the BMDL10s of 17.2 and 33.7 mg/kg-day for females and males, respectively. oral toxicity, explosives, insensitive munitions, sodium periodate, thyroid, uremia REPORT DOCUMENTATION PAGEThe public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services, Directorate for Information , 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. REPORT DATE (DD-MM-YYYY)2. REPORT TYPE 3. DATES COVERED (From -To) 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT NUMBER SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR'S ACRONYM(S) SPONSOR/MONITOR'S REPORT NUMBER(S)12 Good Laboratory Pract ice Compliance StatementThe study described in this report was conducted in compliance with Title 40, Code of Federal Regulations (CFR), Part 792, Good Laboratory Practice Standards, except for the following:1. The test article characterization (purity) was conducted by the manufacturer and it is not known whether the testing was done in compl iance with the above regulation.2. The concentrations of the test article dosing suspensions/solutions for the acute portion of the study were not verified analytically in accordance with Good Laboratory Practice Standards. The a...

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Section: Methodsmentioning

confidence: 99%

Section: Data Collection and Statistical Analysesmentioning

confidence: 99%

Section: Acute Studymentioning

confidence: 99%

Section: V123 Body Weight and Food Consumptionmentioning

confidence: 99%

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Acute and Subacute Oral Toxicity of Periodate in Rats

Lent¹,

Crouse²

2014

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“…Agent Toxicity Studies: VR was injected s.c. in the nape of the neck using a dose volume of 1 ml/kg. A lethality dose-response curve was generated in sequential stages using the stage-wise adaptive approach described by Feder et al (1991aFeder et al ( , 1991bFeder et al ( , 1991c. In each stage 1-2 animals were allocated to each of 4-5 agent challenge levels selected to span the predicted range of lethality from 0-100%.…”

Section: Methodsmentioning

confidence: 99%

Proceedings of the 2001 ECBC Scientific Conference on Chemical and Biological Defense Research, 6-8 March 2001, Marriott's Hunt Valley Inn, Hunt Valley, MD

Berg¹

2001

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Polylactide implants and bacterial contamination: An animal study

Mainil‐Varlet¹,

Hauke²,

Maquet³

et al. 2000

J. Biomed. Mater. Res.

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Although bioresorbable aliphatic polyesters derived from lactic acid are now used clinically as sutures, bone-fracture fixation devices and sustained-release drug-delivery systems, very little is known about their behavior in the infected environment. The aim of the present study was to compare the resistance to infection of two polylactide implants with different degradation characteristics, and to evaluate the influence of a bacterial challenge on their mechanical and physicochemical properties. Various quantities of a beta-haemolyzing strain of Staphylococus aureus (V 8189-94) were inoculated into the medullary cavity of rabbit tibiae, and an extruded polylactide rod composed of either P(L)LA (Poly(L-Lactide)) or P(L/DL)LA (Poly(L/DL-Lactide)) was then inserted. Animals were sacrificed four weeks after surgery. The tibiae and implants were removed under sterile conditions and evaluated microbiologically by culturing. The severity of infection was graded according to positive colony-forming units in the bone. The mechanical properties of the retrieved implants were assessed by 4-point bending and shear tests, performed in compliance with the ASTM D790 standard and their physicochemical characteristics also were characterized. P(L)LA and P(L/DL)LA implants were equally resistant to local infection, their mechanical and physicochemical properties being unaffected by bacterial challenge. Hence, once an infection has become established, the release of bactericidal/bacteriostatic by-products during implant degradation does not appear to affect its natural course. The release of bactericidal/bacteriostatic degradation products at the implantation site is unlikely to affect the natural course of an established infection.

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Stagewise, group sequential experimental designs for quantal responses. One-sample and two-sample comparisons

Cited by 29 publications

References 5 publications

Acute and Subacute Oral Toxicity of Periodate in Rats

Acute and Subacute Oral Toxicity of Periodate in Rats

Proceedings of the 2001 ECBC Scientific Conference on Chemical and Biological Defense Research, 6-8 March 2001, Marriott's Hunt Valley Inn, Hunt Valley, MD

Polylactide implants and bacterial contamination: An animal study

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