Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC...
...The values for DEHP equivalent dose were used to derive TI/Dose ratios for aggregate.....values for the number of units transfused were used to calculate total DEHP dose, the.....derive appropriately protective TI/Dose ratios, upper-bound concentrations of DEHP were..
http://www.fda.gov/cdrh/ost/dehp-pvc.pdf (score=100)

MDI and DPI Drug Products
...An alternative approach may be used if such approach satisfies the requirements of the.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation.....and they are currently used by over 25 million Americans for a variety of diseases, such..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=97)

...The mathematical equations used to derive the estimates of the radiation dose and the.....The range of doses selected for study should include at least one dose that is equivalent to and one dose that is a multiple.....Plasma may be used instead of serum, provided that the anticoagulant used does not affect..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=92)

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...used at too low a dose or whether the apparently less well-tolerated treatment has been.....may also be used with the primary objective of comparing the efficacy and/or safety of the.....design that could unfairly favor one treatment are choice of dose or patient population..
http://www.fda.gov/cder/guidance/4155fnl.pdf (score=86)

Guidance for Industry: Developing Medical Imaging Drug and Biological...
...administered at a mass dose that is at the low end of the dose-response curve, dose.....A glossary of common terms used in diagnostic medical imaging is provided at the end of.....that is lower than if the dose selection had been based on the results of acute, single..
http://www.fda.gov/cber/gdlns/medimagesaf.pdf (score=73)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...The mathematical equations used to derive the estimates of the radiation dose and the.....higher estimate of the absorbed dose determined from either of these systems should be.....study should include at least one dose that is equivalent to and one dose that is a..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=96)

Guidance for Industry
...possible, the formulation that will be used for marketing should be used during phase 2.....We recommend that sponsors explore the consequences of both mass dose and radiation dose.....An alternative approach may be used if such approach satisfies the requirements of the..
http://www.fda.gov/cder/guidance/5742prt3.pdf (score=96)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...used if such approach satisfies the requirements of the applicable statutes and.....or lot, of a PET drug typically consists of one multiple-dose vial containing the PET drug.....or give erroneous or invalid test results when improperly used or maintained, is clean, G..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=96)

Liquid Chemical Sterilants
...Multiple dose levels of residue components should be used to construct a dose-response curve to which the.....Reuse life should only be used as the maximum number of days the germicide can be used.....minimum effective concentration endpoint from dose response studies and/or minimum..
http://www.fda.gov/cdrh/ode/lcgguide.html (score=96)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...Virus or DNA preparations used as preventive vaccines are not covered by this document.....A no-effect level dose, an overtly toxic dose, and several intermediate..doses should be determined, and.....which are used in addition to the cells may be categorized as excipients, additional..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=92)

PET Drug Products - Current Good Manufacturing Practice (CGMP)
...An alternative approach may be used if such approach satisfies the requirements of the.....Currently, a batch, or lot, of a PET drug typically consists of one multiple-dose vial.....Manufacturing practices are the methods, facilities, and controls used in the preparation..
http://www.fda.gov/cder/guidance/4259dft.htm (score=92)

CBER - Workshop on Development of Donor Screening Assays for West Nile Virus
...This could be 1 in 100,000 units, we don't know, but until a method is used extensively.....The first one is a UVA illuminator that delivers the required dose of UVA, and the second.....To validate pathogen inactivation using these systems, we have used full-sized therapeutic..
http://www.fda.gov/cber/minutes/wnv110502.htm (score=92)

Document
...drugs are used in hospitals, so bar codes errors involving radiopharmaceuticals, bar codes.....are the incremental costs above what the drug purchases to be in unit-dose form. have not.....Contract printers are commonly used for with bar codes for specified concerns, contracted..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=90)

...An alternative approach may be used if such approach satisfies the requirements of the.....Appendix 5 Calculation of Estimated Particles per Dose This is applicable to those viruses.....The approach used by manufacturers in their overall strategy for ensuring viral safety..
http://www.fda.gov/cber/gdlns/virsafe.txt (score=90)

ICH: Guidance on Viral Safety Eveluation of Biotechnology Products Derived...
...used in the context of the understanding of the biology of the virus and the nature of the.....particles per dose. studies for a production process are likely to.. the human tropism of.....EXAMPLES OF THE USE AND LIMITATIONS OF ASSAYS WHICH MAY BE USED TO TEST FOR VIRUS..
http://www.fda.gov/cber/gdlns/virsafe.pdf (score=84)

...Doses used should be chosen according to the principles outlined in the ICH guidances S1C.....However, active studies pose special difficulties in interpretation and should be used only when a placebo cannot be used and.....Repeat-Dose General Toxicity Studies The primary objective of long-term, repeat-dose..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=79)

CBER - Workshop on Standards for Inactivation and Clearance of Infectious...
...When a much larger dose was given, something that is like a clinical dose or maybe twice a clinical dose that might be.....Viral filters are being widely used now and they're now even being used in recombinant products and recombinant products just.....5 percent protein is the concentration of immunoglobulin that is manufactured and used..
http://www.fda.gov/cber/minutes/infcagnt1025.htm (score=75)

stability guidance -draft
...demonstrate that the closure used with a multiple-dose vial is capable of withstanding the.....approach may be used if such an approach satisfies the requirements of the applicable.....under refrigerator or freezer temperatures, or certain studies on metered dose inhalations..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=75)

640-PAIN RELIEF GUIDANCE - PANEL SUMMARY
...An alternative approach may be used if such approach satisfies the requirements of the.....Clinical trials of a medical treatment for arthritis pain include experimental dose.....More than 50 different drugs were used by the subjects and many took medications..
http://www.fda.gov/cdrh/ode/640.html (score=73)

...In cases where this approach is used, it will be important to show that the alteration has.....dose and route of product administration, frequency and duration of product administration.....Method of transgene introduction The methods used to introduce recombinant DNA into..
http://www.fda.gov/cber/gdlns/ptc_tga.txt (score=73)

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