Clinical Trials of Investigational Antiepileptic Drugs: Monotherapy Designs

No abstract is available for this paper.

• Publication year

  1991

• Venue

  Epilepsia

• Publication date

  1991-10-01

• Fields of study

  Medicine

• Identifiers
  DOI 10.1111/j.1528-1157.1991.tb04715.xPMID 1915182
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• Perspective of the Pharmaceutical Industry

  1990cited by this paper
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• Changes in seizure activity following anticonvulsant drug withdrawal

  1990cited by this paper
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  1985cited by this paper
• Hippocampal neuron loss in epilepsy and after experimental seizures

  1982cited by this paper
• Hippocampal neuron loss in epilepsy and after experimental seizures.

  1982cited by this paper
• Two antiepileptic drugs for intractable epilepsy with complex-partial seizures.

  1982cited by this paper
• Government Viewpoint of Clinical Trials

  1982cited by this paper
• Barbiturate withdrawal syndrome.

  1967cited by this paper
• A comparison of the behavioral and physiological changes accompanying sleep deprivation and chlorpromazine administration in man.

  1962cited by this paper
• Federal food, drug and cosmetic act.

  1955cited by this paper

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  2015cites this paper
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  2014cites this paper
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  2012cites this paper
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  2011cites this paper
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  2010cites this paper
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  2003cites this paper
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  2002cites this paper
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  2001cites this paper
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  2001cites this paper
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  2001cites this paper
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  2001cites this paper
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  2001cites this paper
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  2001cites this paper
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  2000cites this paper
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  1999cites this paper
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  1999cites this paper
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  1999cites this paper
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  1998cites this paper
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  1998cites this paper
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  1998cites this paper
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  1997cites this paper
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  1995cites this paper
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• [Anticonvulsive drug therapy. Historical and current aspects].

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  1994cites this paper
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  1994cites this paper
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  1994cites this paper
• [The pharmacologic and clinical profile of the new anticonvulsant felbamate--an overview].

  1994cites this paper
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