Welcome to Panopharma.com!

Biopharma Companies

• Biotech Co. List with profiles
• Biotech Co. List with investor Links

FDA Regulations:

Biopharmaceutics - FDA Guidance Document

• Bioanalytical Method Validation [HTML] or [PDF] (Issued 5/2001, Posted 5/22/2001)
• Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations [Word] or [PDF] (Issued 3/2003, Posted 3/19/2003)
• Cholestyramine Powder in Vitro Bioequivalence (Intermin Guidance)
• Clozapine Tablets in Vivo Bioequivalence and in Vitro Dissolution Testing (Issued 11/15/1996, Reposted 10/15/1998)
• Corticosteroids, Dermatologic (topical) In Vivo (Issued 6/2/1995, Posted 3/6/1998)
• Dissolution Testing of Immediate Release Solid Oral Dosage Forms or WordPerfect 6.x Version (Issued 8/1997, Posted 8/25/1997)
• Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (Issued 9/1997, Posted 9/26/1997)
• Food-Effect Bioavailability and Fed Bioequivalence Studies [Word] or [PDF] (Issued 12/2002, Posted 1/30/2003) 
• Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro  (Issued 6/27/1989, Posted 3/2/1998)
• Phenytoin/Phenytion Sodium (capsules, tablets, suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing  (Issued 3/4/1994, Posted 3/2/1998)
• Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing  (Revised 6/6/1994, Posted 6/22/1998)
• Statistical Approaches to Establishing Bioequivalence [HTML] or [PDF] (Issued 2/2001, Posted 2/1/2001)
• Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.  Optional Format: PDF. (Issued 8/2000, Posted 8/31/2000)

Biopharmaceutics (Draft) - FDA Guidance Document

• Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action [Word] or [PDF] (Posted 4/2/2003)
  • Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data  (Posted 4/11/2003)
• Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing [Word] or [PDF] (Posted 12/29/2003)
• Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence [HTML] or [PDF] (Issued 3/6/2000, Posted 3/6/2000)
• Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 8/2002, Posted 8/6/2002)