In vitro models to predict the in vivo mechanism, rate, and extent of placental transfer of dideoxynucleoside drugs against human immunodeficiency virus

Tuntland, Tove; Odinecs, Aleksandrs; Pereira, Conrad M.; Nosbisch, Connie; Unadkat, Jashvant D.

doi:10.1016/s0002-9378(99)70175-4

Cited by 34 publications

(24 citation statements)

References 30 publications

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“…For example, human placental lobe perfusion systems have shown that mechanisms of placental drug transport rates and extent can be investigated in vitro (Bassily et al, 1995;Tuntland et al, 1999;Sastry, 1999). Human trophoblast culture systems, both primary cultures and cell lines, also exist, including those that form monolayers, and have been used to study uptake and transport mechanisms at the cellular and molecular levels (Ringler and Strauss, 1990;Yui et al, 1994;Bloxam et Audus, K.L.…”

Section: Approaches To Investigation Of the Human Placental Barriermentioning

confidence: 99%

“…A point to be made is that in vitro systems are more often derived from mature placenta and may not represent the early pregnancy when drug exposure may be even more critical for the developing fetus. Collectively, the in vitro systems have ultimately provided what few details we have on specific mechanisms mediating the distribution of nutrients, hormones, drugs, and drugs of abuse across the human placenta (Malek et al, 1996;Knipp et al, 1999;Ganapathy et al, 1999;Tuntland et al, 1999;Sastry, 1999).…”

Section: Approaches To Investigation Of the Human Placental Barriermentioning

confidence: 99%

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Controlling drug delivery across the placenta

Audus

1999

European Journal of Pharmaceutical Sciences

105

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Abstract:A challenge in modern drug therapy is to develop strategies for safer and more selective targeting of drug delivery in pregnancy. Specifically, approaches are needed that would restrict unnecessary drug exposure to either mother or fetus. There is evidence emerging that indicates the placenta does express natural transport and metabolism processes that function to control drug and nutrient distribution between the mother and fetus. Further, in vitro techniques developed in the past ten years now provide some of the tools necessary to elucidate transport and metabolism processes typical of the human placenta. As a consequence, pharmaceutical scientists are in a position to contribute significantly to the design and development of drugs for pregnancy. Controlling drug delivery across the placenta: A commentary. Eur. J. Pharm. Sci. 8, 161-165. PMID: 10379038. Publisher's official version: http://dx

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Section: Approaches To Investigation Of the Human Placental Barriermentioning

confidence: 99%

Section: Approaches To Investigation Of the Human Placental Barriermentioning

confidence: 99%

Controlling drug delivery across the placenta

Audus

1999

European Journal of Pharmaceutical Sciences

105

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“…[14] The in-vivo and ex-vivo results for drugs that cross the placenta by passive diffusion are very similar. [15] On the other hand, there are instances where the two approaches have shown contradictory results, such as those found with the protease inhibitor class of antiretrovirals for which initial in-vivo studies suggested that they did not cross the placenta, [16] but ex-vivo studies gave varied results depending on the molecule used. [17,18] By combining all the theoretical data on the drug, and human and animal data obtained during the early development phases (in particular pharmacokinetics), a qualified (rather than a precisely quantified) estimation of the therapeutic range can be obtained from the clinical development of a new product, for both the mother and the fetus.…”

Section: Mother/baby Pharmacokineticsmentioning

confidence: 99%

Methodology for the Evaluation of Drugs in Pregnant Women

et al. 2003

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Although drugs are prescribed during pregnancy with some reluctance, they fulfil a real need in some circumstances. Adequate drug evaluation is thus essential, either based on efficacy and safety or mainly safety, using available data from non-pregnant women. Evaluation methodology is not fundamentally different during pregnancy. Recommendations for drug development are formulated on the basis of the most common situations as well as specific suggestions, thus raising the awareness of the different partners participating in healthcare (institutions, the pharmaceutical industry and prescribers). In particular, regulatory and economic incentives superimposed upon those recommendations adopted in Europe and the US for orphan diseases should be put into place to assist in the evaluation of drugs used in obstetrics. Medical needs in obstetrics should be better identified, and labelling of drugs for use during pregnancy should be better directed towards prescribers; a national registry of pregnancies should be established in France.

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“…[14] Pour les classes de médicaments dont le passage placentaire se fait par simple diffusion, les résultats in vivo et ex vivo sont concordants. [15] A l'inverse, on peut citer des exemples où les deux approches ont montré des résultats discordants, tels qu'avec des antirétroviraux de la classe des inhibiteurs de protéase, pour lesquels les études initiales in vivo suggéraient une absence de passage placentaire, [16] alors que les études ex vivo ont démontré des différences de passage selon la molécule. [17,18] C'est de la confrontation de l'ensemble des données théo- [19] …”

Section: Pharmacocinétique Mère / Enfantunclassified

Méthodologie de l’évaluation des médicaments chez la femme enceinte

2003

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RésuméObjet de réticences diverses, la prescription médicamenteuse chez la femme enceinte répond pourtant à une absolue nécessité dans un certain nombre de cas. Une évaluation correcte du médicament s'impose donc, axée sur l'efficacité et la sécurité ou essentiellement sur la sécurité, selon l'expérience disponible en dehors de la grossesse. La méthodologie d'évaluation ne répond pas nécessairement à des caractéristiques particulières. Des recommandations de développement sont formulées suivant les situations les plus fréquentes ainsi que des propositions concrètes, pour permettre une meilleure sensibilisation des différents partenaires de santé impliqués (institutions, industriels et prescripteurs). En particulier, des incitations d'ordre réglementaire et économique, superposables à celles adoptées en Europe et aux Etats-Unis pour les maladies orphelines, devraient être mises en place pour favoriser l'évaluation obstétricale du médicament.

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In vitro models to predict the in vivo mechanism, rate, and extent of placental transfer of dideoxynucleoside drugs against human immunodeficiency virus

Cited by 34 publications

References 30 publications

Controlling drug delivery across the placenta

Controlling drug delivery across the placenta

Methodology for the Evaluation of Drugs in Pregnant Women

Méthodologie de l’évaluation des médicaments chez la femme enceinte

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