Amphotericin B liposome for injection:

• Amphotericin B is encapsulated in liposomes and free (unencapsulated) amphotericin B is available in the circulation.
• The main clinical use is for the treatment of treatment of invasive fungal diseases and for the treatment of visceral leishmaniasis.
• Liposomal bioequivalence studies with amphotericin B for injection should conform to this guideline.
• The principles should also refer to the Guidelines for the Evaluation of Chemical Drugs with Pharmacokinetic Parameters as Endpoints.

Tadalafil tablets

• Used for the treatment of erectile dysfunction (ED)
• Benign Prostatic Hyperplasia (BPH).
• The main component is tadalafil.
• Human bioequivalence studies of tadalafil tablets should be in accordance with these guidelines
• Bioequivalence and other relevant guidelines should be referred to.
• The requirements of these guidelines should also be referred to.

   Loratadine tablets

• They are used clinically for the relief of symptoms associated with allergic rhinitis, such as sneezing, runny nose, itchy nose, nasal congestion, and itching and burning sensations in the eyes.
• Relief from signs and symptoms of chronic hives, itching and other allergic skin diseases.
• The main ingredient is loratadine, whose active metabolite is decarboxyethoxy loratadine.
• The bioequivalence study of loratadine tablets should be in accordance with these guidelines.

Ropofol fumarate and tenofovir disoproxil tablets

• They are used to treat chronic hepatitis B in adults and adolescents (aged 12 years and older, with a minimum weight of 35 kg).
• The bioequivalence study of tenofovir disoproxil fumarate tablets should be in accordance with this guideline.
• Bioequivalence should conform to the Guideline and should also refer to “Evaluation of pharmacokinetic parameters of chemical drugs”.