MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation.....establish a set of criteria to which a drug substance or drug product should conform using..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Submission of an Investigational New Drug Application to OGD
...If a multiple-dose study is to be conducted on a controlled release drug..product on which no single dose study has been.....The study involves a cytotoxic drug product. An IND is required to conduct a bioavailability or.....The maximum single or total daily dose in a single dose study in normal..subjects or patients exceeds that..
http://www.fda.gov/cder/mapp/5240-4.pdf (score=55)

...For a BE determination of an oral product with a long half-life drug, a nonreplicate, single-dose, crossover study can.....Systemic exposure patterns reflect both release of the drug substance from the drug product and a series of possible.....Single-Dose/Multiple-Dose Studies Instances where multiple-dose studies can be useful are..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=54)

Federal Register: August 14, 1997 (Volume 62, Number 157
...A citizen petition claiming that a particular drug product is not subject to the new drug.....It is particularly important to increase the dose very gradually in patients with myxedema.....A citizen petition that contends that a particular drug product is not subject to the new drug..
http://www.fda.gov/cder/fedreg/fr14au97-83.htm (score=54)

...No extensive dose range and dose adjustment studies with this drug product in normal and special populations have been.....This drug product has been used to measure deoxyglucose metabolism in a variety of tissues, e.g.....Optimal visual and contrast quality for imaging times and sequences vary with dose..
http://www.fda.gov/ohrms/dockets/dockets/98d0266/ref0001l.doc (score=54)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...A fixed-dose combination product is one in which two or more separate drug ingredients are combined in a.....This evaluation provides the link between the new combination drug product and the drug.....The optimal study design would be a randomized, single-dose, two-way crossover, in which..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=53)

/a/content.30891
...rate and extent of drug absorption, its pharmacokinetics, 16.. pharmacodynamics, and the.....product for the first time without doing in vivo testing, 25.. and the answer to that is.....Now, if you don't want to go along the dose axis, 5.. you can go vertically. In other..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t2.pdf (score=49)

Guidance for Industry
...would not significantly increase the risk associated with the labeled use of a drug.....Because effectiveness is often related to dose, a dose close to the maximal tolerated dose.....3 New Drug, Antibiotic, and Biologic Drug Product Regulations, Federal Register, March 19..
http://www.fda.gov/cder/guidance/6036fnl.pdf (score=45)

Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug...
...associated with the labeled use of a drug product and the study could be conducted without an.....This same dose usually becomes the recommended dose in labeling when the new cancer drug is approved with the knowledge that the dose.....Studies of high-dose therapy in cancer patients are likely to be considered exempt if the..
http://www.fda.gov/cber/gdlns/indcancer.htm (score=44)

Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug...
...increase the risk associated with the labeled use of a drug product and the study could be.....Because effectiveness is often related to dose, a dose close to the maximal tolerated dose.....3 New Drug, Antibiotic, and Biologic Drug Product Regulations, Federal Register, March 19..
http://www.fda.gov/cber/gdlns/indcancer.pdf (score=44)

...Adverse reaction reports associated with a generic OTC ibuprofen drug product marketed under an.....Comparison of an Anti-Inflammatory Dose of Ibuprofen, An Analgesic Dose of Ibuprofen, and Acetaminophen in the Treatment.....The March 17, 1999, standardized format and content requirements final rule for OTC drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/082102a.htm (score=43)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...To qualify for these statutory exemptions, a compounded drug product must satisfy several.....Metered dose inhalers are sophisticated drug delivery systems that require extensive.....One requirement is that the drug product may only be compounded if we have not identified it..
http://www.fda.gov/cder/fdama/difconc.htm (score=42)

...The guidance reflects the Agency's current recommendations regarding the integration of dose-counting mechanisms into MDI.....This would prevent the patient from discarding an inhaler unnecessarily or using the.....Department of Health and Human Services Food and Drug Administration Center for Drug..
http://www.fda.gov/cder/guidance/5308FNL.doc (score=41)

Untitled Document
...It is your responsibility to ensure adherence to each requirement of the Federal Food.....drug product containers, closures, in-process materials, labelin g, and drug products conform.....a) Yellow fever single dose unit lot dose unit lot UA071AA did not meet specifications for..
http://www.fda.gov/foi/warning_letters/g4240d.htm (score=41)

...If you are using as an inactive 5 ingredient a product that is marketed as a finished 6 drug.....A parenthetical explains 13 that finished dosage form includes unit dose 14 containers, multiple dose containers and.....Well, FDA does recognize that 6 for investigational drugs, the drug product, the 7 production..
http://www.fda.gov/cder/regulatory/pet/0521pet.doc (score=40)

Guidance for Industry
...oral inhalation integrate a dose-counting device into the development of their MDI drug product.Dose.....integrate a dose counter into their product as soon as feasible, although the integration.....This guidance is intended to assist manufacturers who are developing or plan to develop..
http://www.fda.gov/cder/guidance/5308FNL.pdf (score=39)

MedWatch - November 2002 Safety-Related Drug Labeling Changes
...The reconstituted drug product should be inspected visually for particulate matter and.....Alternative Infusion Preparation Methods, Preparation of 70-mg Day 1 loading dose from two.....Alternative Infusion Preparation Methods Preparation of 70-mg Day 1 loading dose from two..
http://www.fda.gov/medwatch/SAFETY/2002/nov02.htm (score=39)

Draft Guidance for Industry: Nonclinical Studies for Development of...
...Studies that include the to-be-marketed formulation of the drug product are preferred, if this.....One-month repeat dose toxicology studies should be performed in both a rodent species and.....Three-month repeat dose toxicology studies should be performed in both a rodent species..
http://www.fda.gov/cber/gdlns/dvpexcp.htm (score=38)

Guidance for Industry: Nonclinical Studies for Developmenet of...
...concentrations as the reference listed drug product, with the exception of buffers.....dose(MTD) or the MFD. 6 For cases in which a new excipient is being developed in relation.....proposed new excipients in drug products and to establish permissible and safe limits for..
http://www.fda.gov/cber/gdlns/dvpexcp.pdf (score=38)

FDA APPROVES FIRST NDA FOR LEVOTHYROXINE SODIUM
...The dose of levothyroxine for replacement or supplemental therapy in patients with.....FDA today approved the first NDA for the thyroid hormone replacement drug, levothyroxine.....These problems have resulted in product recalls and have the potential to cause serious..
http://www.fda.gov/bbs/topics/ANSWERS/ANS01029.html (score=37)

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