Detalhe da pesquisa
1.
The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities.
J Pharm Pharm Sci
; 27: 12398, 2024.
Artigo
em Inglês
| MEDLINE | ID: mdl-38577255
2.
A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme.
J Pharm Pharm Sci
; 25: 323-339, 2022.
Artigo
em Inglês
| MEDLINE | ID: mdl-36251699
3.
A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme.
J Pharm Pharm Sci
; 24: 113-126, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-33734975
4.
Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities.
J Pharm Pharm Sci
; 24: 548-562, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-34706215
5.
The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities.
J Pharm Pharm Sci
; 22(1): 486-500, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-33760728
6.
A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme.
J Pharm Pharm Sci
; 22(1): 28-36, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-30599818
7.
A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme.
J Pharm Pharm Sci
; 21(1): 27-37, 2018.
Artigo
em Inglês
| MEDLINE | ID: mdl-29382433
8.
Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence.
J Pharm Pharm Sci
; 19(2): 290-301, 2016.
Artigo
em Inglês
| MEDLINE | ID: mdl-27518176
9.
Characterization of N-glycan heterogeneities of erythropoietin products by liquid chromatography/mass spectrometry and multivariate analysis.
Rapid Commun Mass Spectrom
; 28(8): 921-32, 2014 Apr 30.
Artigo
em Inglês
| MEDLINE | ID: mdl-24623697
10.
Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments.
Pharmaceut Med
; 38(3): 225-239, 2024 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-38684588
11.
First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA.
Ther Innov Regul Sci
; 57(2): 173-177, 2023 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-36100793
12.
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.
BioDrugs
; 37(4): 443-451, 2023 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-37227657
13.
Modernization and Strengthening of Bioequivalence Guidelines in Japan.
Clin Pharmacokinet
; 60(2): 145-151, 2021 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-33247363
14.
Generic Drug Product Development in Japan: Regulatory Updates During 2014-2019 and the Future.
Eur J Drug Metab Pharmacokinet
; 46(6): 711-719, 2021 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-34586614
15.
First approval of generic dry powder inhaler drug products in Japan.
Drug Deliv Transl Res
; 10(5): 1517-1519, 2020 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-32613551
16.
Current Regulation for Bioequivalence Evaluations of Generic Ophthalmic Dosage Forms in Japan.
Eur J Drug Metab Pharmacokinet
; 45(6): 697-702, 2020 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-32930951
17.
Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan.
Eur J Drug Metab Pharmacokinet
; 44(6): 743-745, 2019 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-31062276
18.
Current Japanese Regulatory Systems for Generics and Biosimilars.
J Pharm Sci
; 107(3): 785-787, 2018 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-29113922
19.
Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.
Drugs R D
; 17(3): 371-379, 2017 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-28577294
20.
Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union.
Clin Pharmacokinet
; 56(3): 225-233, 2017 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-27461251