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Statistical evaluation methods of in vitro studies for bioequivalence for orally inhaled and nasal drug products
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Ying GENG1, Quan YANG2, Jun ZHANG3, Rui WANG1, Ying ZHOU1, Jing ZHENG1, Bao-ming NING1, *, Ning-yi WEI1, *
Acta Pharmaceutica Sinica | 2021, 56(10) : 2630 - 2641
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Acta Pharmaceutica Sinica | 2021, 56(10): 2630-2641
• Special Reports: Inhalation Drug Delivery System •
Statistical evaluation methods of in vitro studies for bioequivalence for orally inhaled and nasal drug products
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Ying GENG1, Quan YANG2, Jun ZHANG3, Rui WANG1, Ying ZHOU1, Jing ZHENG1, Bao-ming NING1, *, Ning-yi WEI1, *
Affiliations
  • 1. National Institutes for Food and Drug Control, Beijing 102629, China
  • 2. Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., Beijing 100000, China
  • 3. Chinese Pharmacopoeia Commission, Beijing 100061, China
Published: 2021-10-12 doi: 10.16438/j.0513-4870.2021-0640
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This article systematically reviews the background and regulatory requirements of bioequivalence of orally inhaled and nasal drug products (OINDPs), as well as the basic regulatory requirements for the assessment by the guidelines and guidance issued in China, the United States, and the European Union. Detailed statistical evaluation method considerations and calculations of the US FDA population bioequivalence (PBE) method were presented for the evaluation of in vitro bioequivalence (IVBE) for OINDPs. Using the example described in the FDA Draft Guidance for budesonide inhalation suspension, the PBE analysis statistical parameters were calculated via the R programming, and the results were compared with that in the guidelines. Moreover, pseudo-code for the PBE calculation program was provided. This paper aims to provide guidance and references for the research and development of new drug, as well as pharmaceutical quality control, and development of generic medicinal products for OINDPs.

orally inhaled and nasal drug product  /  bioequivalence  /  in vitro bioequivalence  /  population bioequivalence  /  pseudo-code of calculation program  /  budesonide inhalation suspension
Ying GENG, Quan YANG, Jun ZHANG, Rui WANG, Ying ZHOU, Jing ZHENG, Bao-ming NING, Ning-yi WEI. Statistical evaluation methods of in vitro studies for bioequivalence for orally inhaled and nasal drug products[J]. Acta Pharmaceutica Sinica, 2021 , 56 (10) : 2630 -2641 . DOI: 10.16438/j.0513-4870.2021-0640
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Article Info
doi: 10.16438/j.0513-4870.2021-0640
  • Receive Date：2021-04-27
  • Online Date：2025-12-18
  • Published：2021-10-12
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History
  • Received：2021-04-27
  • Revised：2021-07-15
Affiliations
    1. National Institutes for Food and Drug Control, Beijing 102629, China
    2. Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., Beijing 100000, China
    3. Chinese Pharmacopoeia Commission, Beijing 100061, China
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表12种不同金属材料的力学参数
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Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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