BEBAC  Ing. Helmut Schütz

Website Redesign


Since mid-2008 FDA is redesigning their Internet Archive website. Starting with June 2009 most links to guidances are broken without automatic redirect to new URIs (even FDA’s search-page sometimes leads to a nonexisting resource)…

Documents by title, date, old, and new resources. Click on the heading to sort (JavaScript required):

title date old URL new URL
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
SUPAC-IR Questions and Answers about SUPAC-IR Guidance
1995/11 ?
SUPAC-MR: Modified Release Solid Oral Dosage Forms 1997/09 1214fnl.pdf UCM070640.pdf
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations 1997/09 1306fnl.pdf ucm070239.pdf
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products 1998/05 1397fnl.pdf UCM072008.pdf
Nonsterile Semisolid Dosage Forms
Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
1997/05 1447fnl.pdf ucm070930.pdf
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling 1998/05 1449fnl.pdf ucm072127.pdf
Population Pharmacokinetics 1999/02 1852fnl.pdf ucm072137.pdf
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products 1998/11 1970dft.pdf ucm072114.pdf
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act 1998/06 2576fnl.pdf ucm079342.pdf
In Vivo Drug Metabolism/Drug Interaction Studies — Study Design, Data Analysis, and Recommendations for Dosing and Labeling 1999/11 2635fnl.pdf ucm072119.pdf
Changes to an Approved NDA or ANDA 2004/04 2766fnl.pdf ucm077097.pdf
Statistical Approaches to Establishing Bioequivalence 2001/01 3616fnl.pdf ucm070244.pdf
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System 2000/08 3618fnl.pdf ucm070246.pdf
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling 2003/05 3625fnl.pdf ucm072123.pdf
Bioanalytical Method Validation 2001/05 4252fnl.pdf ucm070107.pdf
Food-Effect Bioavailability and Fed Bioequivalence Studies 2002/12 5194fnl.pdf ucm070241.pdf
Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications 2003/04 5341fnl.pdf ucm072109.pdf
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations 2003/03 5356fnl.pdf ucm070124.pdf
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
Statistical Information for In Vitro Bioequivalence Data
2003/04 5383DFT.pdf
Handling and Retention of BA and BE Testing Samples 2004/05 5522fnl.pdf ucm072869.pdf
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers 2005/07 5541fnl.pdf UCM078932.pdf
Part 11, Electronic Records; Electronic Signatures — Scope and Application 2003/03 5667fnl.pdf
Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling 2006/09 6695dft.pdf ucm072101.pdf
Bioequivalence Recommendations for Specific Products 2007/05 6772dft.pdf ucm072872.pdf
Computerized Systems Used in Clinical Investigations 2007/05 7359fnl.pdf UCM070266.pdf
Submission of Summary Bioequivalence Data for ANDAs 2009/04 8363dft.pdf UCM134846.pdf
Formatting of Bioequivalence Summary Tables 2007/01 DBE_tables.pdf
Critical Path Opportunities for Generic Drugs 2007/05 generic.html ucm077250.htm
General Principles of Software Validation; Final Guidance for Industry and FDA Staff 2002/01 938.pdf ucm085371.pdf
Review of Bioequivalence Studies with Clinical Endpoints in ANDAs 2006/12 5210.4R.pdf ucm079585.pdf
Procedures for Review of Bioequivalence Study Protocols 2006/07 5210-6.rev.pdf ucm079770.pdf
Inspections of Clinical Facilities and Analytical Laboratories Conducting Bioequivalence Studies Submitted in ANDAs 2000/12 5210-7.pdf ucm079772.pdf
Guideline for the Monitoring of Clinical Investigations 1998/11 clinguid.pdf ucm135075.htm
Institutional Review Boards 1997/09 irb-cp7348-809.pdf UCM133768.pdf
Computerized Systems Used In Clinical Trials 1999/04 ffinalcct.PDF
Sponsors, Contract Research Organizations and Monitors 2001/02 48-810.pdf UCM133770.pdf
Clinical Investigators 2008/12 48_811.pdf UCM133773.pdf
GLP Final Rule (1978) 1978/12 78fr-glpfinalrule.pdf UCM133728.pdf
GLP Proposed Rule (1984) 1984/10 84proposedrule.htm UCM133729.pdf
GLP Final Rule (1987) 1987/09 87fr-glpamendment.pdf
GLP Questions and Answers (1981, 1999, 2007) 2007/07 81GLP-qanda.pdf
Reviewer Guidance – Validation of Chromatographic Methods 1994/11 cmc3.pdf UCM134409.pdf
CGMP for Phase 1 Investigational Drugs 2008/07 GMP Phase1IND61608.pdf ucm070273.pdf