In November 2022, the NMPA CDE issued four technical guidelines for bioequivalence study of specific varieties.
The Center for Drug Evaluation issued four technical guidelines for bioequivalence studies of specific varieties which are amphotericin B liposome for injection, tadalafil tablets, loratadine tablets and propofol fumarate and tenofovir disoproxil tablets, respectively.
Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and PK/PD parameters. These studies are often done for generic drugs or when a formulation of a drug is changed during development.
About the Four Technical Guidelines:
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.
- 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.
- 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”.
National Medical Products Administration
Notice of the Center for Drug Review (available in Chinese)
Amphotericin B liposome for injection (available in Chinese)
Tadalafil tablets (available in Chinese)
Loratadine tablets (available in Chinese)
Ropofol fumarate and tenofovir disoproxil tablets (available in Chinese)
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