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US FDA |
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MY HOME PAGE
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Pharmacokinetics |
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Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (Issued 3/2003, Posted 3/19/2003) |
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Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003) |
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Statistical Approaches to Establishing Bioequivalence (Issued 2/2001, Posted 2/1/2001) |
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Handling and Retention of BA and BE Testing Samples (5/25/2004) |
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Extended Release Oral Dosage Forms: Development, Evaluation, and Application of
In Vitro/In Vivo Correlations (9/1997) |
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Bioanalytical Method Validation (5/2001) |
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Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV (10/17/2006) |
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Population Pharmacokinetics (Issued 2/1999, Posted 2/10/1999) |
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Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage
Forms Based on a Biopharmaceutics Classification System (Issued 8/2000, Posted 8/31/2000) |
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Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
(Posted 4/2/2003) |
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Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (11/2006) |
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Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro(8/1997) |
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Abbreviated New Drug Application (ANDA) Process for Generic Drugs |
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Applications covered by 505(b)(2) (Posted 12/7/1999) |
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180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (7/2003) |
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ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information (6/2007) |
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21- CFR |
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21 CFR PART 50 PROTECTION OF HUMAN SUBJECTS |
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21 CFR PART 54 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS |
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21 CFR PART 56 INSTITUTIONAL REVIEW BOARDS |
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21 CFR PART 60 PATENT TERM RESTORATION |
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21 CFR PART 314 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG |
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21 CFR PART 320 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS |
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US FDA AUDIT |
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So you have an US FDA Audit..... Check out the following guidelines. This will help you to prepare for the audit.
1. In Vivo Bioequivalence
2. Institutional Review Boards (IRB)
3. Clinical Investigators (CI)
4. Sponsors, Contract Research Organizations and Monitors |
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PHASE I CLINICAL TRIALS |
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Investigational New Drug (IND) Application Process |
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Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers (21/2005) |
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Exploratory IND Studies (12/2006) |
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Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (10/2000) |
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IRB |
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Guidance for Institutional Review Boards and Clinical Investigators 1998 Update |
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Waiver of IRB Requirements for Drug and Biological Product Studies !/2006) |
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Click here for other guidelines |
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E-mail : |
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[email protected] |
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