Guidance In the Manufacture and Clinical Evaluation of In Vitro Tests to...
...Specificity and Sensitivity Studies for Test Kits with a Proposed Labeling for Screening.....appropriate test samples are obtained for all donations included in a pool and..that all.....of the proposed claim for clinical utility and the clinical studies that will be performed..
http://www.fda.gov/cber/gdlns/hivnas.pdf (score=100)

stability guidance -draft
...should be assayed for the chemical content of the preservatives at all appropriate test.....Testing for extractables/leachables on stability studies may be appropriate in situations.....The stability studies for sterile drug products should include data from a sterility test..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=99)

MDI and DPI Drug Products
...For MDI and DPI drug products, certain studies should be performed to determine.....stability test storage conditions. Additional studies should be performed to characterize.....discuss significant departures from the approaches outlined in this guidance with the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=95)

FDA NCI Workshop on Tumor Vaccines
...range which might be appropriate for future studies, 8.. and also to get some sense of the.....test the ability of fibrocytes to prime naive T- 18.. cells in vivo, fibrocytes were.....and/or target antigen distribution studies, 23.. whichever is appropriate for the..
http://www.fda.gov/cber/minutes/tumor121098.pdf (score=92)

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...5 question of independent replication, in both of the studies, 6 the 2-milligram dose had.....15 are trying to test a medication in agitated patients. 16 Another factor that goes on is.....8 hour didn't seem appropriate. What we can tell you is that, 9 for the slide that you did..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3685t2.pdf (score=91)

...The use of BE studies with clinical trial endpoints can be appropriate to demonstrate BE for orally administered drug products when.....In BE studies, an applicant compares the systemic exposure profile of a test drug product.....BE studies with food focus on demonstrating comparable BA between test and reference..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=91)

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...in a defined way as part of the same trial that studies the test treatment, and over the.....Each type of control group is appropriate in some circumstances, but none is usable or.....Comparative dose-response studies, in which there are several doses of both test and..
http://www.fda.gov/cder/guidance/4155fnl.pdf (score=88)

PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...If no appropriate anti-mAb antibody test is available,a properly validated test system should be developed by the.....Virus clearance studies should be supported by appropriate statistical analysis.....and to identify potential clinical utility of the test to be further explored in later..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=92)

...If no appropriate anti-mAb antibody test is available, a properly validated test system should be developed by the.....Statistics Virus clearance studies should be supported by appropriate statistical analysis.....Reproductive and developmental studies including teratogenicity in an appropriate animal..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=91)

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...process test and the drug substance test, the acceptance criterion for the in-process test.....dissolution or bioavailability of the drug product, and further studies on the drug.....apply the content recommendations in this guidance, as scientifically appropriate, and/or..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=91)

...Test substance concentrations for in vitro studies should span a broad range, covering and exceeding the anticipated maximal.....The following criteria should be considered in selecting the most appropriate test systems.....5 Follow-up studies Follow-up studies are intended to provide greater depth of understanding or additional..
http://www.fda.gov/cder/guidance/5533dft.doc (score=90)

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...process test and the drug substance test, the acceptance criterion for the in-process test.....dissolution or bioavailability of the drug product, and further studies on the drug.....apply the content recommendations in this guidance, as scientifically appropriate, and/or..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=90)

ICH S7B Guideline Step 2 Revision: The Nonclinical Evaluation of the...
...The following criteria should be considered in selecting the most appropriate test systems.....studies should be considered to facilitate ranking the potency of the test substance in.....Pharmacodynamic studies, Toxicology/safety studies, Pharmacokinetic studies, including plasma levels of parent..
http://www.fda.gov/cber/gdlns/ichqt.htm (score=89)

Workshop on Use of Radiolabeled Platelets for Assessment or In Vivo...
...between radiolabeled studies and in vitro studies, whereas for new storage media or extension beyond 7 days.....reinfused on the day of reinfusion of the test platelets, the same concept as in the.....don't think it's appropriate for us to ask companies, personally, to go looking at..
http://www.fda.gov/cber/minutes/radioplt050304.pdf (score=88)

ICH: Guidance on Viral Safety Eveluation of Biotechnology Products Derived...
...4 Not necessary if positive by retrovirus infectivity test.5 As appropriate for cell lines which are.....bioburden of the unprocessed bulk, clearance studies are listed in Table A­1. arrived as.....6 For the first WCB, this test should be performed on cells at the limit of in vitro cell..
http://www.fda.gov/cber/gdlns/virsafe.pdf (score=88)

...In certain instances, it may be more appropriate to test a mixture consisting of both intact and.....Limitations of Viral Clearance Studies Viral clearance studies are useful for contributing to the assurance that.....In addition to clearance studies for viruses known to be present, studies to characterize the ability to remove and/or inactivate..
http://www.fda.gov/cber/gdlns/virsafe.txt (score=87)

...dissolution for solid oral dosage forms, sterility for parenterals, animal safety test for parenterals, when.....However, additional nonclinical studies may be appropriate to adequately characterize the.....Draft protocols for carcinogenicity studies should be submitted to the appropriate review..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=87)

Document
...The studies included antiperspirant-treated axilla to rate of ..in sweat production.....definition test, there was at least a 20- the last antiperspirant application. controlled.....appropriate effectiveness data and an .. aluminum in the blood enters the brain, VerDate..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=86)

Guidance for Industry: Phrmacogenomic Data Submissions
...defines nonclinical laboratory studies as "in vivo or in vitro experiments in which test.....many pharmacogenomic results are not well enough established scientifically to be.....The term does not include studies utilizing human subjects or clinical studies or field..
http://www.fda.gov/cber/gdlns/pharmdtasub.pdf (score=86)

...The term does not include basic exploratory studies carried out to determine whether a.....If you cannot identify the appropriate FDA staff, call the appropriate number listed on.....The term does not include studies utilizing human subjects or clinical studies or field..
http://www.fda.gov/cder/guidance/5900dft.doc (score=86)

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