Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...Virus or DNA preparations used as preventive vaccines are not covered by this document.....See"Guideline on validation of the limulus amebocyte lysate test as an end-product.....which are used in addition to the cells may be categorized as excipients, additional..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=100)
MDI and DPI Drug Products
...An alternative approach may be used if such approach satisfies the requirements of the.....stability test storage conditions. Additional studies should be performed to characterize.....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=99)
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...Justification for an in-process test that is used in lieu of a drug substance test should.....same principles for evaluating solid state form can be used, when appropriate, for other.....solvent on an isolated intermediate may be sufficient to satisfy a test listed in the drug..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=97)
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...Justification for an in-process test that is used in lieu of a drug substance test should.....same principles for evaluating solid state form can be used, when appropriate, for other.....solvent on an isolated intermediate may be sufficient to satisfy a test listed in the drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=93)
GLOSSARY OF COMPUTERIZED SYSTEM AND SOFTWARE DEVELOPMENT TERMINOLOGY
...A software tool used to test requirements in design specifications for both consistency and.....A software tool used to perform calculations or determine accuracy of computer manipulated.....Tools that test the validity of assertions as the program is executing or tools that..
http://www.fda.gov/ora/inspect_ref/igs/gloss.html (score=91)
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...used at too low a dose or whether the apparently less well-tolerated treatment has been.....happened to patients if they had not received the test treatment or if they had received a.....may also be used with the primary objective of comparing the efficacy and/or safety of the..
http://www.fda.gov/cder/guidance/4155fnl.pdf (score=83)
Points to Consider on the Characterization of Cell Lines Used to Produce...
...Nonreplicating viruses, used as vectors for gene therapy, may be tested in the usual cell.....If performed by the supplier, indicate if you receive detailed test results or summary.....toxicity or interference in assays used to determine the virus titer, as these components..
http://www.fda.gov/cber/gdlns/ptccell.pdf (score=115)
PET Drug Products … Current Good Manufacturing Practice (CGMP)
...used if such approach satisfies the requirements of the applicable statutes and.....of false-positive results arises in the sampling and transfer of the test aliquot from the.....If the result of any BET exceeds the acceptance limit, or if a sterility test is positive..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=99)
PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
...Validation of the LAL Test as an End-Product Endotoxin Test for Human and Animal.....commonly used in conjunction with mAb for ex vivo manipulations of cellular products.....Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin..
http://www.fda.gov/cber/gdlns/ptc_mab.pdf (score=99)
PET Drug Products - Current Good Manufacturing Practice (CGMP)
...If a USP analytical test method is used, it should be verified that the method works under the actual.....An alternative approach may be used if such approach satisfies the requirements of the.....A reaction-based identity test for O 18 water is the production of F 18 by nuclear..
http://www.fda.gov/cder/guidance/4259dft.htm (score=95)
...For complex biological mixtures, the lots of test antigen and/or inhibitors used for direct binding tests should be.....See also "Guidelines on Validation of the LAL Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs.....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=95)
...The choice of cells used in the test is governed by the species of origin of the cell bank to be.....An alternative approach may be used if such approach satisfies the requirements of the.....unprocessed bulk may be toxic in test cell cultures, whereas partially processed bulk may..
http://www.fda.gov/cber/gdlns/virsafe.txt (score=93)
BIOTECHNOLOGY INSPECTION GUIDE
...Various forms of the LAL test include a gel clot test, a colormetric test, a chromogenic test, and a turbidimetric.....The same criteria used for acceptance of the natural product should be used for the.....The LAL test is easier, quicker, less costly and much more sensitive that the rabbit test..
http://www.fda.gov/ora/inspect_ref/igs/biotech.html (score=91)
Guidance for Industry: Manufacturing, Processing, or Holding Active...
...adulterated if the methods used in, or the facilities or controls used for, its manufacture,processing, packing, or holding do.....Deviations from written specifications, standards,sampling plans, test procedures, or.....solvents, if the solvent is specifically used for cleaning and is not a solvent used in..
http://www.fda.gov/cder/guidance/1289dft.pdf (score=91)
GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
...An alternative approach may be used if such..approach satisfies the requirements of the.....criteria that are numerical limits, ranges, or other criteria for the test described. 1842.....31 Procedures should be used to reconcile the quantities of labels issued, used, 854.. and..
http://www.fda.gov/cder/guidance/4011dft.pdf (score=88)
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.....4 Not necessary if positive by retrovirus infectivity test.5 As appropriate for cell lines.....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=86)
Blood Product Inspections
...Test methods used for ABO, Rh and antibody screening, which are different from the manufacturer's.....A typical ELISA test such as that used for the detection of antibody to HIV utilizes beads or microtiter.....Reagents used in microplate test systems should be recommended for this use by the manufacturer's package..
http://www.fda.gov/ora/inspect_ref/igs/blood.html (score=85)
Substance
...individual batches of the drug substance used in animal and clinical testing, Drug.....intermediate(s) or steps in the process to test, and the kind of testing required, are the.....testing used to monitor its identity, strength, quality, and purity. A description of the..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=82)
...However, active studies pose special difficulties in interpretation and should be used only when a placebo cannot be used and.....We recommend that this test be performed for crude extracts from natural sources.....An alternative approach may be used if such approach satisfies the requirements of the..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=80)
stability guidance -draft
...and the test methods used to monitor the stability of the drug substance and preliminary.....and the test methods used to monitor the stability of the drug product packaged in the.....acceptance criteria of such parameters, and the test methodology used to assess such..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=76)
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