DPQR: What is PQRI?
...Drug Substance, Drug Product, Biopharmaceutics, Science Management, and Novel Approaches for.....drug development and evaluation. PQRI will conduct research to develop science based..
http://www.fda.gov/cder/dpqr/what.htm (score=100)

Drug Master Files Guidance
...A Type II DMF should, in general, be limited to a single drug intermediate, drug substance, drug product, or type.....Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug.....Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug..
http://www.fda.gov/cder/guidance/dmf.htm (score=82)

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...It is possible that information for more than one drug substance, drug product, or indication.....section's numbering, making it clear that the data are for an additional drug substance.....content of the new drug application submission. To avoid generating and compiling..
http://www.fda.gov/cder/guidance/4539O.PDF (score=62)

/a/content.11865
...For the patent referenced above, provide the following information on the drug substance, drug.....1 Does the patent claim the drug substance that is the active ingredient in the drug.....This patent declaration form is required to be submitted to the Food and Drug..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542a.pdf (score=45)

Drug Master Files
...Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug.....Drug Substance: The current Guideline for Drug Substances cited in the DMF Guideline is in the.....Type II DMFs may be submitted in the format for "Drug substance" in the "Guidance for..
http://www.fda.gov/cder/dmf/index.htm (score=45)

/a/content.17993
...Open Public Hearing, Orally Inhaled and Nasal Drug Products: Overview of ITFG/IPAC-RS.....changes of drug substance, drug product specifications, 25.. changes of drug product components.....raw materials and active drug substance manufacture. 20.. Findings of this team were that there..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t1.pdf (score=44)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process material.....a different drug substance or different drug product manufacturing site will not be distributed..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=44)

M4: Organization of the CTD
...It is possible that information for more than one drug substance, drug product, or indication.....FDA has guidance regarding the format and content of the new drug application submission.....drug substance, drug product, or indication. For example, for an additional indication, repeat..
http://www.fda.gov/cder/guidance/4539O.htm (score=44)

Guidance for Industry: M4: The Organization of the CTD
...It is possible that information for more than one drug substance, drug product, or indication.....section's numbering, making it clear that the data are for an additional drug substance.....content of the new drug application submission. To avoid generating and compiling..
http://www.fda.gov/cber/gdlns/m4ctd.pdf (score=44)

...drug substance, drug product, biopharmaceutics, science management, and novel approaches for.....Drug Manufacturers Association, National Pharmaceutical Alliance, Parenteral Drug.....drug substance and drug product, (3) enhance review consistency and efficiency, and (4..
http://www.fda.gov/OHRMS/DOCKETS/98fr/021800b.txt (score=44)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process material.....a different drug substance or different drug product manufacturing site will not be distributed..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=44)

Preventable Adverse Drug Reactions: A focus on drug interactions
...1 To reliably detect the toxic effects of a drug with a 1 in 20,000 adverse drug reaction frequency, the new drug.....In addition to the drug-drug interactions just reviewed, drug-disease interactions can.....substance (drug or food as we will see later) that inhibits the enzyme. So if two drugs..
http://www.fda.gov/cder/drug/drugReactions/default.htm (score=28)

...These regulations require documentation of the drug substance, drug product, placebo, labeling.....one in which the components or ingredients and composition of the drug substance and drug.....Batch-to-batch consistency should be demonstrated for the botanical drug substance and drug..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=27)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug Substance.....Production of a drug substance, whether by synthesis, fermentation, or isolation, usually.....the NDA for the new drug substance, as well as the limits for impurities, should be based on..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=27)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....drug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q.....recommends that the drug substance information be included in a master file or incorporated in..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=27)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....drug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q.....recommends that the drug substance information be included in a master file or incorporated in..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=27)

...If the patent claims an approved method of using the approved drug product to administer.....Drug Substance (Active Ingredient) Complete all items in this section if the patent claims the.....1 Does the patent claim the drug substance that is the active ingredient in the | |drug product..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542a.doc (score=27)

Drug Master Files
...An agent for DMF purposes is not the same as an agent for the purposes of the Drug Listing.....Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug.....Drug Substance: The current Guideline for Drug Substances cited in the DMF Guideline is in the..
http://www.fda.gov/cder/dmf/ (score=26)

WAIS Document Retrieval
...For the impurity test, the discrimination may be established by spiking drug substance or drug.....For example, where a titration is adopted to assay the drug substance for release, the.....It may be demonstrated directly on the drug substance (by dilution of a standard stock solution..
http://www.fda.gov/cder/guidance/ichq2b.htm (score=26)

Guidance for Industry: Q3A Impurities in New Drug Substances
...with raw materials that could contribute to the impurity profile of the new drug substance, and.....the response factors of a drug substance and the relevant impurity are not close, this practice.....A tabulation should be provided that links the specific new drug substance batch to each safety..
http://www.fda.gov/cber/gdlns/ichq3a.pdf (score=26)

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