March 97 Medical Bulletin
...The drug is contained in a paste that is applied directly to the ulcers four times a day.....A label change for this product has been made that includes the total drug content (100 mg/5 mL.....Block Drug Company Inc. of Jersey City, New Jersey, manufactures amlexanox under the trade..
http://www.fda.gov/medbull/mar97/articles.htm (score=100)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....The guidance sets forth information that should be provided to ensure continuing drug..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=61)

...I guess what concerns me is how do you really know, when you go from drug to drug and person to.....If we look at all the secondary parameters with the exception of the dermal content, we.....When you really think about it and you look at all the steps here, in an oral drug the drug is in..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3804t2.htm (score=60)

...The amount of acceptable variation in drug content should be evaluated in the context of the.....Such controls represent a diversion of effort away from assurance of adequate drug product quality, drug.....and /or as the potency as indicated by appropriate laboratory tests such as weight and..
http://www.fda.gov/ohrms/dockets/dockets/03N0059/03n-0059-c00001-vol1.doc (score=59)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The moisture content in the micronized material should be tightly controlled for drug.....This test is useful for detection of large particles and agglomerates of the drug substance, can define morphology of drug.....Conversely, portions of the immediate container's content cannot be removed from a..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=58)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The moisture content in the micronized material should be tightly controlled for drug.....This test is useful for detection of large particles and agglomerates of the drug substance, can define morphology of drug.....Conversely, portions of the immediate container's content cannot be removed from a..
http://www.fda.gov/cder/guidance/2180dft.htm (score=58)

Orange Book Preface
...The strength of parenteral drugs products is defined as the total drug content of the container.....The Prescription Drug Product, OTC Drug Product and Discontinued Drug Product sections may be searched by.....content is not a consideration, pharmaceutical alternatives with the same total amount of..
http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm (score=58)

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...for nasal sprays,identity of the drug substance, spray pattern, osmolality, and net.....in the drug substance or drug product specification and is individually listed and limited.....indirectly by determining concentration and actual net content, if justified.A suitable..
http://www.fda.gov/cder/guidance/4234fnl.pdf (score=58)

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...When each drug is administered intravenously, the steady-state volume of distribution is 1.....Patients taking drugs associated with drug-induced methemoglobinemia such as sulfonamides.....recovered in the urine as metabolites or parent drug. The systemic clearance is 10 to 20..
http://www.fda.gov/cder/foi/label/2000/19941S11LBL.PDF (score=58)

News Along the Pike August 2000
...We take pride in making the right deci- were adverse to a newly approved drug, pride and.....In addition to drug content unifor- with the American Association of Phar- will discuss the.....cal Document for the Registration of Pharma- content in the same format to the regulatory..
http://www.fda.gov/cder/pike/aug2000.pdf (score=58)

ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...desired product, a product-related substance, microbial limits, volume in container.....either the drug substance or drug product. product, which may occur during storage, a drug substance should.....procedures and acceptance criteria which, stability of drug substance and drug product. A qualitative..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=58)

News Along the Pike, July 2000
...In addition to drug content uniformity in the final product, blending operations can also.....The lectures covered DNA and RNA biotechnology and its application in drug discovery, drug development and.....Manufacturers following a final M-4 guidance will be able to submit the same content in..
http://www.fda.gov/cder/pike/aug2000.htm (score=58)

PET Drug Applications - Content and Format for NDAs and ANDAs
...Sample formats for the content and format of the chemistry sections for each PET drug are.....As discussed in the previous section, an applicant can submit an ANDA to the FDA for a drug product that is the same as a.....The content and format sections provide all the information required in the submission of..
http://www.fda.gov/cder/guidance/3453dft.htm (score=58)

/a/content.10805
...Use of any drug in pregnancy, during lactation or in women of..childbearing age requires.....from the sugar-coated tablets, but the drug content remains unchanged. ACTION..Tranylcypromine.....In combination with cheese or other foods with a high tyramine content.. Hypertensive..
http://www.fda.gov/cder/foi/label/2001/12342s51lbl.pdf (score=58)

Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products -...
...In addition, the potential effect of micronization processes on the levels of amorphous content and foreign particulates in the.....for nasal sprays, identity of the drug substance, spray pattern, osmolality, and net.....A specific identification test or tests should be used to verify the identity of the drug substance in the drug..
http://www.fda.gov/cder/guidance/4234fnl.htm (score=58)

Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical...
...drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise.....coating integrity/durability, drug content/uniformity), incomplete in vitro pharmacokinetics.....the drug substance was subject to drug GMPs while the drug-device combination product was subject to the quality system..
http://www.fda.gov/oc/combination/workshop070803.html (score=58)

Guidance for Industry: Nonsterile Semisolid Dosage Forms
...Aliquots removed from the receptor phase can be analyzed for drug content by high pressure.....This guidance provides recommendations to pharmaceutical sponsors of new drug applications.....dissolved in one phase, although occasionally the drug is not fully soluble in the system..
http://www.fda.gov/cder/guidance/1447fnl.pdf (score=58)

...The drug content of the test product cannot differ from that of the reference listed product by.....Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane.....Systemic exposure patterns reflect both release of the drug substance from the drug product and a series of..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=58)

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...increased risk for bleeding because of drug-drug interactions and effects on platelets. Aspirin.....Hemodialysis and peritoneal dialysis can be performed to reduce the body drug content. In.....Drug Interactions..No pharmacokinetic drug-drug interaction studies were conducted with..
http://www.fda.gov/cder/foi/label/1999/20884lbl.PDF (score=58)

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...increased risk for bleeding because of drug-drug interactions and effects on platelets. Aspirin.....Hemodialysis and peritoneal dialysis can be performed to reduce the body drug content. In.....Drug Interactions..No pharmacokinetic drug-drug interaction studies were conducted with..
http://www.fda.gov/cder/foi/label/1999/20884lbl.pdf (score=58)

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