MDI and DPI Drug Products
...For MDI and DPI drug products, certain studies should be performed to determine.....establish a set of criteria to which a drug substance or drug product should conform using.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...will be performed, analytical procedures that will be used, and acceptance criteria that will be met.....tests, studies, analytical procedures, and acceptance criteria appropriate to assess the.....that you review the tests, studies, analytical procedures, and acceptance criteria in your..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=48)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...will be performed, analytical procedures that will be used, and acceptance criteria that will be met.....tests, studies, analytical procedures, and acceptance criteria appropriate to assess the.....that you review the tests, studies, analytical procedures, and acceptance criteria in your..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=46)

þÿ
...associated acceptance criteria depend on the route of administration of the drug product and the.....dissolution or bioavailability of the drug product, and further studies on the drug.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=57)

þÿ
...associated acceptance criteria depend on the route of administration of the drug product and the.....dissolution or bioavailability of the drug product, and further studies on the drug.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=56)

510(k) Submissions for Coagulation Instruments - Guidance for Industry and...
...When describing your acceptance criteria or summary data, we recommend that you include the slope.....system for in vitro coagulation studies is a device cons isting of one automated or semi.....Protocol and acceptance criteria for value assignment and validation, including any specific..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=49)

Draft Guidance: ICH Q5E: Comparability of Biotechnological/Biological...
...Based on this evaluation, acceptance criteria to define highly similar post-change product can be.....If a manufacturer can provide assurance of comparability through analytical studies alone, nonclinical or clinical studies with.....The comparison of the results to the predefined acceptance criteria allows an objective assessment of..
http://www.fda.gov/cber/gdlns/ichcompbio.htm (score=39)

Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA)...
...We may also request additional information if we need it to assess the adequacy of your acceptance.....The appropriateness of conducting accelerated stability studies is related to device.....3 If FDA makes a substantial equivalence determination based on acceptance criteria, the subject..
http://www.fda.gov/cdrh/ode/guidance/668.html (score=36)

6003dft.doc
...on this evaluation, acceptance criteria to define highly similar post-change product can.....knowledge from process development studies, small scale evaluation/validation studies, 331.....to assist in the design and conduct of studies used to collect the technical information..
http://www.fda.gov/cder/guidance/6003dft.pdf (score=36)

International Conference on Harmonisation; Draft Guidance on Q5E...
...on this evaluation, acceptance criteria to define highly similar post-change product can.....knowledge from process development studies, small scale evaluation/validation studies, 331.....to assist in the design and conduct of studies used to collect the technical information..
http://www.fda.gov/cber/gdlns/ichcompbio.pdf (score=36)

Assisted Reproduction Laser Systems - Class II Special Controls Guidance...
...statement that conformance assessment to specified acceptance criteria will be performed before the.....While, in general, clinical studies will not be needed for most assisted reproduction.....We may also request additional information if we need it to assess the adequacy of your acceptance..
http://www.fda.gov/cdrh/ode/guidance/1539.html (score=35)

...We recommend that you review the tests, studies, analytical procedures, and acceptance criteria in your approved comparability.....We recommend that you determine whether the tests, studies, analytical procedures, and acceptance criteria described in your.....We recommend that you specify each change and define the acceptance criteria for evaluating the..
http://www.fda.gov/cder/guidance/protcmc.doc (score=33)

ANDAs: Impurities in Drug Substances, Guidance Document
...If data are unavailable to qualify the proposed acceptance criteria of an impurity, studies to obtain such data may be needed.....In summary, the drug substance acceptance criteria should include, where applicable, acceptance.....Stability studies, chemical development studies, and routine batch analyses can be used to predict those impurities..
http://www.fda.gov/cder/guidance/2452fnl.htm (score=31)

ANDAs: Impurities in Drug Substances
...If data are unavailable to qualify the proposed acceptance criteria of an impurity, studies to obtain.....In other words, where there is no safety concern,impurity acceptance criteria should be based on data.....commercial process, as well as results of intentional degradation studies used to identify..
http://www.fda.gov/cder/guidance/2452fnl.pdf (score=31)

...This can be accomplished by examining and/or testing to ensure that the acceptance criteria are met.....When such studies have been conducted, data from the studies must be included in an IND for a botanical drug to assist FDA in its.....Nonclinical pharmacology and toxicology studies are useful in guiding early clinical studies and in predicting the potential toxicity..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=31)

stability guidance -draft
...such cases, alternate approaches, such as qualifying higher acceptance criteria for a.....long-term and accelerated stability studies and annual batches thereafter on long-term.....If the stability data under the ICH conditions fall outside the acceptance criteria while..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=28)

Guidance In the Manufacture and Clinical Evaluation of In Vitro Tests to...
...validation of coating methods including ratios used and acceptance criteria for the.....Specificity and Sensitivity Studies for Test Kits with a Proposed Labeling for Screening.....of the proposed claim for clinical utility and the clinical studies that will be performed..
http://www.fda.gov/cber/gdlns/hivnas.pdf (score=28)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...Assessment of stability typically includes assaying each active ingredient to meet acceptance.....For additional details about food-effect bioavailability studies and fed bioequivalence studies, see the guidance for.....Acceptance criteria for process impurities and degradants should be set based on manufacturing..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=27)

...Based on this evaluation, acceptance criteria to define highly similar post-change product can be.....If a manufacturer can provide assurance of comparability through analytical studies alone, nonclinical or clinical studies with.....The comparison of the results to the predefined acceptance criteria allows an objective assessment of..
http://www.fda.gov/cder/guidance/6003dft.doc (score=26)

Tamiflu NDA 21-246
...Reassess the acceptance criteria for degradants in the drug product specification when the.....Complete additional studies to evaluate the antibody responses to both wild-type and.....In additional studies, further evaluate the oseltamivir carboxylate pharmacokinetic..
http://www.fda.gov/cder/foi/appletter/2000/21246ltr.pdf (score=26)

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