Review of global regulations concerning biowaivers for immediate release solid oral dosage forms.
about
Statistical comparison of dissolution profiles to predict the bioequivalence of extended release formulations.Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?Clinical relevance of dissolution testing in quality by design.In vitro studies are sometimes better than conventional human pharmacokinetic in vivo studies in assessing bioequivalence of immediate-release solid oral dosage forms.Application of the biopharmaceutical classification system in clinical drug development--an industrial view.The use of gastrointestinal intubation studies for controlled release development.A biorelevant dissolution stress test device - background and experiences.In silico and in vitro prediction of gastrointestinal absorption from potential drug eremantholide C.Risk analysis in bioequivalence and biowaiver decisions.In vitro dissolution of generic immediate-release solid oral dosage forms containing BCS class I drugs: comparative assessment of metronidazole, zidovudine, and amoxicillin versus relevant comparator pharmaceutical products in South Africa and IndiaIn silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen.Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence.Pharmacodynamic testing and new validated HPLC method to assess the interchangeability between multi-source orlistat capsules.An improved prediction of the human in vivo intestinal permeability and BCS class of drugs using the in vitro permeability ratio obtained for rat intestine using an Ussing chamber system.Evaluating bioequivalence of meloxicam tablets: is in-vitro dissolution test overdiscriminating?
P2860
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P2860
Review of global regulations concerning biowaivers for immediate release solid oral dosage forms.
description
2006 nî lūn-bûn
@nan
2006年の論文
@ja
2006年論文
@yue
2006年論文
@zh-hant
2006年論文
@zh-hk
2006年論文
@zh-mo
2006年論文
@zh-tw
2006年论文
@wuu
2006年论文
@zh
2006年论文
@zh-cn
name
Review of global regulations c ...... lease solid oral dosage forms.
@ast
Review of global regulations c ...... lease solid oral dosage forms.
@en
type
label
Review of global regulations c ...... lease solid oral dosage forms.
@ast
Review of global regulations c ...... lease solid oral dosage forms.
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prefLabel
Review of global regulations c ...... lease solid oral dosage forms.
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Review of global regulations c ...... lease solid oral dosage forms.
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P2093
P1476
Review of global regulations c ...... lease solid oral dosage forms.
@en
P2093
Barends DM
Dressman JB
Harmsze AM
Yamashita E
P304
P356
10.1016/J.EJPS.2006.05.001
P407
P577
2006-05-10T00:00:00Z