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
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
Inglês
| MEDLINE | ID: mdl-36251699
3.
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
Inglês
| MEDLINE | ID: mdl-34706215
4.
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
Inglês
| MEDLINE | ID: mdl-33734975
5.
Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen.
Chirality
; 32(9): 1169-1177, 2020 09.
Artigo
Inglês
| MEDLINE | ID: mdl-32602190
6.
Effect of enantiomerism on the bioequivalence of a new ibuprofen 600-mg tablet formulation obtained by roller compaction.
Chirality
; 32(2): 185-190, 2020 02.
Artigo
Inglês
| MEDLINE | ID: mdl-31755587
7.
Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia.
Br J Clin Pharmacol
; 85(9): 2059-2065, 2019 09.
Artigo
Inglês
| MEDLINE | ID: mdl-31140620
8.
Sex-by-formulation interaction in bioequivalence trials with transdermal patches.
Eur J Clin Pharmacol
; 75(6): 801-808, 2019 Jun.
Artigo
Inglês
| MEDLINE | ID: mdl-30725220
9.
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
Inglês
| MEDLINE | ID: mdl-33760728
10.
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
Inglês
| MEDLINE | ID: mdl-30599818
11.
In Vitro Dissolution as a Tool for Formulation Selection: Telmisartan Two-Step IVIVC.
Mol Pharm
; 15(6): 2307-2315, 2018 06 04.
Artigo
Inglês
| MEDLINE | ID: mdl-29746133
12.
Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets.
Br J Clin Pharmacol
; 84(8): 1729-1737, 2018 08.
Artigo
Inglês
| MEDLINE | ID: mdl-29633302
13.
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
Inglês
| MEDLINE | ID: mdl-29382433
14.
Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base.
Chirality
; 28(5): 429-33, 2016 05.
Artigo
Inglês
| MEDLINE | ID: mdl-27094918
15.
About the equivalence between different batches of a glycopeptide drug.
Pharm Dev Technol
; 21(5): 642-5, 2016 Aug.
Artigo
Inglês
| MEDLINE | ID: mdl-25886080
16.
Agitation Rate and Time for Complete Dissolution in BCS Biowaivers Based on Investigation of a BCS Biowaiver for Dexketoprofen Tablets.
Mol Pharm
; 12(9): 3194-201, 2015 Sep 08.
Artigo
Inglês
| MEDLINE | ID: mdl-26237401
17.
Investigating the Discriminatory Power of BCS-Biowaiver in Vitro Methodology to Detect Bioavailability Differences between Immediate Release Products Containing a Class I Drug.
Mol Pharm
; 12(9): 3167-74, 2015 Sep 08.
Artigo
Inglês
| MEDLINE | ID: mdl-26287948
18.
Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons.
Eur J Clin Pharmacol
; 71(9): 1083-9, 2015 Sep.
Artigo
Inglês
| MEDLINE | ID: mdl-26105964
19.
Composition specification of teicoplanin based on its estimated relative bioavailability.
Drug Dev Ind Pharm
; 41(2): 218-23, 2015 Feb.
Artigo
Inglês
| MEDLINE | ID: mdl-24506456
20.
Response to 'Sex-by-formulation interaction in bioequivalence studies: the importance of formulations and experimental conditions' by Ibarra et al.
Br J Clin Pharmacol
; 85(4): 857-858, 2019 04.
Artigo
Inglês
| MEDLINE | ID: mdl-30690756