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Volumn 17, Issue 5, 2015, Pages 1305-1311

Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference

Author keywords

bioequivalence; emerging markets; generics; MDIs and DPIs; regulatory science

Indexed keywords

GENERIC DRUG; DRUG;

EID: 84939566474     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9791-z     Document Type: Article
Times cited : (11)

References (10)
  • 1
    • 84939572291 scopus 로고    scopus 로고
    • Regulatory considerations for approval of generic inhalation drug products in the US, EU, Brazil, China, and India
    • Lee SL, Saluja B, García-Arieta A, Santos GML, Li Y, Lu S, et al. Regulatory considerations for approval of generic inhalation drug products in the US, EU, Brazil, China, and India. AAPS J. 2015. doi:10.1208/s12248-015-9787-8.
    • (2015) AAPS J
    • Lee, S.L.1    Saluja, B.2    García-Arieta, A.3    Santos, G.M.L.4    Li, Y.5    Lu, S.6
  • 2
    • 84939569736 scopus 로고    scopus 로고
    • Inhalation devices and patient interface: human factors
    • Leiner S, Parkins D, Lastow O. Inhalation devices and patient interface: human factors. AAPS J. 2015;17(2): 457–461. doi: 10.1208/s12248-015-9717-9http://link.springer.com/article/10.1208/s12248-015-9717-9. Accessed 21 Jan 2015.
    • (2015) AAPS J. , vol.17 , Issue.2 , pp. 457-461
    • Leiner, S.1    Parkins, D.2    Lastow, O.3
  • 3
    • 84931571234 scopus 로고    scopus 로고
    • In vitro testing for orally inhaled products: developments in science-based regulatory approaches
    • Accessed 19 May 2015
    • Forbes B, Bäckman P, Christopher D, Dolovich M, Li BV, Morgan B. In vitro testing for orally inhaled products: developments in science-based regulatory approaches. AAPS J. 2015. doi: 10.1208/s12248-015-9763-3. http://www.pharmagateway.net/ArticlePage.aspx?DOI=10.1208/s12248-015-9763-3. Accessed 19 May 2015.
    • (2015) AAPS J.
    • Forbes, B.1    Bäckman, P.2    Christopher, D.3    Dolovich, M.4    Li, B.V.5    Morgan, B.6
  • 4
    • 84936953257 scopus 로고    scopus 로고
    • Pharmacokinetics of orally inhaled drug products
    • Hochhaus G, Horhota S, Hendeles L, Suarez S, Rebello J. Pharmacokinetics of orally inhaled drug products. AAPS J. 2015. doi: 10.1208/s12248-015-9736-6. http://www.pharmagateway.net/ArticlePage.aspx?DOI=10.1208/s12248-015-9736-6. Accessed 15 April 2015.
    • (2015) AAPS J
    • Hochhaus, G.1    Horhota, S.2    Hendeles, L.3    Suarez, S.4    Rebello, J.5
  • 5
    • 84939564601 scopus 로고    scopus 로고
    • Pharmacodynamic studies to demonstrate bioequivalence of oral inhalation products
    • Accessed 19 May 2015
    • Hendeles L, Daley-Yates PT, Hermann R, Backer J, Dissanayake S, Horhota ST. Pharmacodynamic studies to demonstrate bioequivalence of oral inhalation products. AAPS J. 2015; 17 (3): 758–768. doi: 10.1208/s12248-015-9735-7. http://link.springer.com/article/10.1208%2Fs12248-015-9735-7. Accessed 19 May 2015.
    • (2015) AAPS J. , vol.17 , Issue.3 , pp. 758-768
    • Hendeles, L.1    Daley-Yates, P.T.2    Hermann, R.3    Backer, J.4    Dissanayake, S.5    Horhota, S.T.6
  • 6
    • 84939572687 scopus 로고    scopus 로고
    • Application of the modified chi-square ratio statistic in a stepwise procedure for cascade impactor equivalence testing
    • Accessed 15 April 2015
    • Weber B, Lee SL, Delvadia R, Lionberger R, Li BV, Tsong Y, Hochhaus G. Application of the modified chi-square ratio statistic in a stepwise procedure for cascade impactor equivalence testing. AAPS J. 2015; 17 (2): 370–379. doi: 10.1208/s12248-014-9698-0. http://www.pharmagateway.net/ArticlePage.aspx?DOI=10.1208/s12248-014-9698-0. Accessed 15 April 2015
    • (2015) AAPS J. , vol.17 , Issue.2 , pp. 370-379
    • Weber, B.1    Lee, S.L.2    Delvadia, R.3    Lionberger, R.4    Li, B.V.5    Tsong, Y.6    Hochhaus, G.7
  • 7
    • 84939567533 scopus 로고    scopus 로고
    • Effect of device design and formulation on the in vitro comparability for multi-unit dose dry powder inhalers
    • Shur J, Saluja B, Lee S, Tibbatts J, Price R. Effect of device design and formulation on the in vitro comparability for multi-unit dose dry powder inhalers. AAPS J. May 2015. doi: 10.1208/s12248-015-9775-z. http://link.springer.com/article/10.1208/s12248-015-9775-z. Accessed 19 May 2015.
    • (2015) AAPS J
    • Shur, J.1    Saluja, B.2    Lee, S.3    Tibbatts, J.4    Price, R.5
  • 8
    • 84931571717 scopus 로고    scopus 로고
    • In vitro, pharmacokinetic, pharmacodynamic, and safety comparisons of single and combined administration of tiotropium and salmeterol in COPD patients using different dry powder inhalers
    • Accessed 15 April 2015
    • Horhota ST, Noord JA, Verkleij CB, Bour LJ, Sharma A, Trunk M, Cornelissen PJG. In vitro, pharmacokinetic, pharmacodynamic, and safety comparisons of single and combined administration of tiotropium and salmeterol in COPD patients using different dry powder inhalers. AAPS J. 2015. doi: 10.1208/s12248-015-9751-7. http://www.pharmagateway.net/ArticlePage.aspx?DOI=10.1208/s12248-015-9751-7. Accessed 15 April 2015.
    • (2015) AAPS J.
    • Horhota, S.T.1    Noord, J.A.2    Verkleij, C.B.3    Bour, L.J.4    Sharma, A.5    Trunk, M.6    Cornelissen, P.J.G.7
  • 9
    • 84939971649 scopus 로고    scopus 로고
    • Safety of β2-agonists in asthma: linking mechanisms, meta-analyses and regulatory practice
    • Dissanayake SB. Safety of β2-agonists in asthma: linking mechanisms, meta-analyses and regulatory practice. AAPS J. 2015. doi: 10.1208/s12248-015-9734-8. http://www.pharmagateway.net/ArticlePage.aspx?DOI=10.1208/s12248-015-9734-8. Accessed 15 April 2015.
    • (2015) AAPS J
    • Dissanayake, S.B.1
  • 10
    • 84939562203 scopus 로고    scopus 로고
    • IPAC-RS and UF. Orlando Inhalation Conference: Approaches in International Regulation. 2014. Accessed 26 Nov 2014
    • IPAC-RS and UF. Orlando Inhalation Conference: Approaches in International Regulation. 2014. http://www.cvent.com/events/orlando-inhalation-conference-approaches-in-international-regulation/agenda-8a749091c2c741228907ca5c70b619eb.aspx. Accessed 26 Nov 2014.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.