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US 2011/0085984 A1Published application
Drug Product and Process for Making
OwnerJames M. Frincke, Armando Garsdinventors
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Abstract
The invention provides a drug product for treating radiation exposure comprising, a drug in a dosage form; and packaging for the drug together with a package insert or label that includes information about the drug's efficacy, where the information about the drug's efficacy is obtained at least in part from methods described in the disclosure.
Claims19
A method to obtain a drug product comprising
- (i) exposing mammals, wherein the mammals are not humans or rodents, to a whole body radiation dose of at least about an LD10 to obtain exposed subjects;
- (ii) obtaining exposed treated subjects by administering a drug candidate to at least some of the exposed subjects and obtaining exposed placebo subjects by administering a suitable placebo to at least some of the exposed subjects, wherein neither the exposed treated subjects nor the exposed placebo subjects are provided with any other ameliorative treatment other than analgesics to treat pain if needed;
- (iii) measuring the survival rate of the exposed treated subjects to obtain a treatment survival rate and measuring the survival rate of the exposed placebo subjects to obtain a placebo survival rate, whereby at least some of the information in the package insert or label about the drug candidate's efficacy was obtained;
- and
- (iv) submitting the information of step (iii) to a regulatory agency, wherein the drug product is for treating radiation exposure or acute radiation syndrome and the drug product comprises a drug in a dosage form, packaging for the drug and a package insert or label, whereby at least some the information in the package insert or label about the drug's effect on survival after exposure to the biological insult, efficacy, mechanism of action, patient population, dosage, dose regimen, route of administration or toxicity was obtained.
2 more elements
A drug product for treating radiation exposure or acute radiation syndrome comprising, (a) a drug in a dosage form;
- and (b) packaging for the drug together with a package insert or label that includes information about the drug's efficacy, wherein the efficacy information was obtained at least in part from a method that comprises (i) exposing mammals, wherein the mammals are not humans or rodents, to a whole body radiation dose of at least about an LD30 to obtain exposed subjects;
- (ii) obtaining exposed treated subjects by administering the drug to at least some of the exposed subjects and obtaining exposed placebo subjects by administering a suitable placebo to at least some of the exposed subjects, wherein neither the exposed treated subjects nor the exposed placebo subjects are provided with any other ameliorative treatment other than analgesics to treat pain if needed;
- and (iii) measuring the survival rate of the exposed treated subjects to obtain a treatment survival rate and measuring the survival rate of the exposed placebo subjects to obtain a placebo survival rate, whereby at least some of the information in the package insert or label about the drug's efficacy was obtained, wherein the package insert or label indicates that the drug product is for treating radiation exposure or acute radiation syndrome and the drug product is approved for sale to treat radiation exposure or acute radiation syndrome.
A method to identify a surrogate marker for the lethality of a biological insult comprising,
- (i) exposing mammals having one or more measured baseline bioparameters to a biological insult of at least about an LD30 to obtain exposed subjects, wherein the mammals are not humans or rodents and wherein the exposed subjects are not provided with any other ameliorative treatment other than analgesics to treat pain if needed;
- (ii) measuring the bioparameters of the exposed subjects on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or more days, with measurements beginning on the same day that the exposed subjects were exposed to the biological insult or beginning within about 1-30 days after the mammals were exposed to the biological insult, whereby a surrogate marker for lethality is obtained.
Dependencies are inferred from the claim text.