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Understanding Pharmaceutical Quality by Design
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) thatExpand
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Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions
The current BSC guidance issued by the FDA allows for biowaivers based on conservative criteria. Possible new criteria and class boundaries are proposed for additional biowaivers based on theExpand
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Effect of common excipients on Caco-2 transport of low-permeability drugs.
The Biopharmaceutics Classification System (BCS) allows waivers of in vivo bioequivalence for rapidly dissolving immediate-release (IR) formulations of drugs with high solubility and highExpand
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Influence of Passive Permeability on Apparent P-glycoprotein Kinetics
AbstractPurpose. The objectives of this work were to evaluate the importance of moderate passive permeability on apparent P-glycoprotein (P-gp) kinetics, and demonstrate that inspection ofExpand
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Biowaiver monographs for immediate release solid oral dosage forms: diclofenac sodium and diclofenac potassium.
Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage formsExpand
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The solute carrier family 10 (SLC10): beyond bile acid transport.
The solute carrier (SLC) family 10 (SLC10) comprises influx transporters of bile acids, steroidal hormones, various drugs, and several other substrates. Because the seminal transporters of thisExpand
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Rapid Identification of P-glycoprotein Substrates and Inhibitors
Identifying molecules that interact with P-glycoprotein (P-gp) is important for drug discovery but is also generally reliant on time-consuming in vitro and in vivo studies. As an alternativeExpand
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Effects of nonionic surfactants on membrane transporters in Caco-2 cell monolayers.
  • B. Rege, J. Kao, J. Polli
  • Chemistry, Medicine
  • European journal of pharmaceutical sciences…
  • 1 September 2002
The objectives of this study were (1) to investigate the transporter inhibition activity of three nonionic surfactants on P-glycoprotein, the human intestinal peptide transporter, and theExpand
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Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets.
The objectives of this work were to apply several profile comparison approaches to dissolution data of four different but bioequivalent metoprolol tartrate tablet formulations to (1) identify theExpand
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Apical sodium dependent bile acid transporter (ASBT, SLC10A2): a potential prodrug target.
A major hurdle impeding the successful clinical development of drug candidates can be poor intestinal permeability. Low intestinal permeability may be enhanced by a prodrug approach targetingExpand
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