PMID- 35094370
OWN - NLM
STAT- MEDLINE
DCOM- 20220519
LR  - 20230131
IS  - 2008-2231 (Electronic)
IS  - 1560-8115 (Print)
IS  - 1560-8115 (Linking)
VI  - 30
IP  - 1
DP  - 2022 Jun
TI  - Assessment of the predictive capability of modelling and simulation to determine 
      bioequivalence of inhaled drugs: A systematic review.
PG  - 229-243
LID - 10.1007/s40199-021-00423-7 [doi]
AB  - OBJECTIVES: There are a multitude of different modelling techniques that have 
      been used for inhaled drugs. The main objective of this review was to conduct an 
      exhaustive survey of published mathematical models in the area of asthma and 
      chronic obstructive pulmonary disease (COPD) for inhalation drugs. Additionally, 
      this review will attempt to assess the applicability of these models to assess 
      bioequivalence (BE) of orally inhaled products (OIPs). EVIDENCE ACQUISITION: 
      PubMed, Science Direct, Web of Science, and Scopus databases were searched from 
      1996 to 2020, to find studies that described mathematical models used for inhaled 
      drugs in asthma/COPD. RESULTS: 50 articles were finally included in this 
      systematic review. This research identified 22 articles on in silico aerosol 
      deposition models, 20 articles related to population pharmacokinetics and 8 
      articles on physiologically based pharmacokinetic modelling (PBPK) modelling for 
      inhaled drugs in asthma/COPD. Among all the aerosol deposition models, 
      computational fluid dynamics (CFD) simulations are more likely to predict 
      regional aerosol deposition pattern in human respiratory tracts. Across the 
      population PK articles, body weight, gender, age and smoking status were the most 
      common covariates that were found to be significant. Further, limited published 
      PBPK models reported approximately 29 parameters relevant for absorption and 
      distribution of inhaled drugs. The strengths and weaknesses of each modelling 
      technique has also been reviewed. CONCLUSION: Overall, while there are different 
      modelling techniques that have been used for inhaled drugs in asthma and COPD, 
      there is very limited application of these models for assessment of 
      bioequivalence of OIPs. This review also provides a ready reference of various 
      parameters that have been considered in various models which will aid in 
      evaluation if one model or hybrid in silico models need to be considered when 
      assessing bioequivalence of OIPs.
CI  - (c) 2021. Springer Nature Switzerland AG.
FAU - Rebello, Juliet
AU  - Rebello J
AUID- ORCID: 0000-0002-4795-7657
AD  - Clinical Research Division, Cipla Ltd, Mumbai, Maharashtra, India. 
      juliet@cipla.com.
FAU - Brashier, Bill
AU  - Brashier B
AD  - Clinical Research Division, Cipla Ltd, Mumbai, Maharashtra, India.
FAU - Shukla, Sharvari
AU  - Shukla S
AUID- ORCID: 0000-0002-7029-5532
AD  - Symbiosis Statistical Institute (SSI), Symbiosis International University, Pune, 
      Maharashtra, India.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20220130
PL  - Switzerland
TA  - Daru
JT  - Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences
JID - 101125969
RN  - 0 (Aerosols)
SB  - IM
MH  - Administration, Inhalation
MH  - Aerosols
MH  - *Asthma/drug therapy
MH  - Computer Simulation
MH  - Humans
MH  - Models, Biological
MH  - *Pulmonary Disease, Chronic Obstructive/drug therapy
MH  - Therapeutic Equivalency
PMC - PMC9114201
OTO - NOTNLM
OT  - Asthma and COPD
OT  - Computational fluid dynamics
OT  - Inhalation
OT  - PBPK
OT  - Population pharmacokinetics
COIS- The authors declare that they have no competing interests.
EDAT- 2022/01/31 06:00
MHDA- 2022/05/20 06:00
PMCR- 2023/01/30
CRDT- 2022/01/30 20:38
PHST- 2021/02/12 00:00 [received]
PHST- 2021/10/18 00:00 [accepted]
PHST- 2022/01/31 06:00 [pubmed]
PHST- 2022/05/20 06:00 [medline]
PHST- 2022/01/30 20:38 [entrez]
PHST- 2023/01/30 00:00 [pmc-release]
AID - 10.1007/s40199-021-00423-7 [pii]
AID - 423 [pii]
AID - 10.1007/s40199-021-00423-7 [doi]
PST - ppublish
SO  - Daru. 2022 Jun;30(1):229-243. doi: 10.1007/s40199-021-00423-7. Epub 2022 Jan 30.