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1.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-33734975
2.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-33760728
3.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-30599818
4.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-29382433
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