Ba&BE Required for some dosage forms:

Bioavailability and/ or Bioequivalent study is required for the following:
  • According to the pharmaceutical dosage forms.
    • Tablets except (antacids, chewable tablet, soluble tablet, tablets which have more than two active constituents, tablets containing vitamins or multi vitamins).
    • Capsules except (vitamins containing capsules and those have a number of active ingredients).
    • Suppositories, except (those with local effects).
    • Oral suspension except (antacid and those with local effect).
    • Creams and Ointments which have systemic effect like nitroglycerine cream.
    • Oily and suspension injection.
    • Transdermal patches.
  • According to the pharmaceutical dosage forms.
    • Tablets except (antacids, chewable tablet, soluble tablet, tablets which have more than two active constituents, tablets containing vitamins or multi vitamins).
    • Capsules except (vitamins containing capsules and those have a number of active ingredients).
    • Suppositories, except (those with local effects).
    • Oral suspension except (antacid and those with local effect).
    • Creams and Ointments which have systemic effect like nitroglycerine cream.
    • Oily and suspension injection.
    • Transdermal patches.
  • According to the pharmacological action (tablets and capsules)
  • Cardiovascular drug;
      • Positive inotropic drugs (Digoxine).
      • Diuretics.
      • Antiarrythmic.
      • Beta blockers.
      • Antihypertensive drugs.
      • Nitrates and Calcium channel blockers.
      • Sympathomimetics.
      • Anticoagulants.
      • Fibrinolytics.
      • Anti- fibrinolytics and Haemostatics.
      • Lipid lowering drugs.
    • Central nervous system drugs;
      • Hypnotics and tranquilizers.
      • Psychoses drugs.
      • Anti depressants.
      • CNS stimulants.
      • Drugs for Nausea and Vertigo.
      • Parkinsonism drugs.
    • Anti infective drugs; All oral antibiotics.
    • Endocrine system drugs;
      • Drugs for Diabetes.
      • Thyroid and Anti-thyroid drugs.
      • Corticosteroids.
      • Sex Hormones.
      • Hypothalamic and Pituitary hormones.
      • Drugs affecting bone metabolism.
    • Immunosuppressant;
      • Cytotoxic drugs.
      • Drugs affecting immune response.