Clinical development of atypical antipsychotics: Research design and evaluation

Herbert Y. Meltzer*

*Corresponding author for this work

Research output: Contribution to journalReview article

20 Citations (Scopus)

Abstract

Clinical trials support the efficacy and safety of new drags on the market. They provide the United States Food and Drug Administration with the information needed to approve an Investigational New Drug application and are the basis for package inserts provided by the manufacturers that guide clinicians in the use of a new drug. Because clinical trials are vital to the effective and safe use of new drugs, it is important to understand who participates in them, what questions are answered by clinical trials, and what questions are raised. The reader who asks the proper questions about issues such as methodology, affiliations of the investigators; statistical analyses performed, location of study centers, and study populations will derive the most information from the report of a clinical trial.

Original languageEnglish (US)
Pages (from-to)10-16
Number of pages7
JournalJournal of Clinical Psychiatry
Volume59
Issue numberSUPPL. 12
StatePublished - Oct 5 1998

Fingerprint

Antipsychotic Agents
Research Design
Clinical Trials
Investigational New Drug Application
Product Labeling
United States Food and Drug Administration
Pharmaceutical Preparations
Research Personnel
Safety
Population

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

@article{3dbce06bb126493eb63582073bd67b01,
title = "Clinical development of atypical antipsychotics: Research design and evaluation",
abstract = "Clinical trials support the efficacy and safety of new drags on the market. They provide the United States Food and Drug Administration with the information needed to approve an Investigational New Drug application and are the basis for package inserts provided by the manufacturers that guide clinicians in the use of a new drug. Because clinical trials are vital to the effective and safe use of new drugs, it is important to understand who participates in them, what questions are answered by clinical trials, and what questions are raised. The reader who asks the proper questions about issues such as methodology, affiliations of the investigators; statistical analyses performed, location of study centers, and study populations will derive the most information from the report of a clinical trial.",
author = "Meltzer, {Herbert Y.}",
year = "1998",
month = "10",
day = "5",
language = "English (US)",
volume = "59",
pages = "10--16",
journal = "Journal of Clinical Psychiatry",
issn = "0160-6689",
publisher = "Physicians Postgraduate Press Inc.",
number = "SUPPL. 12",

}

Clinical development of atypical antipsychotics : Research design and evaluation. / Meltzer, Herbert Y.

In: Journal of Clinical Psychiatry, Vol. 59, No. SUPPL. 12, 05.10.1998, p. 10-16.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Clinical development of atypical antipsychotics

T2 - Research design and evaluation

AU - Meltzer, Herbert Y.

PY - 1998/10/5

Y1 - 1998/10/5

N2 - Clinical trials support the efficacy and safety of new drags on the market. They provide the United States Food and Drug Administration with the information needed to approve an Investigational New Drug application and are the basis for package inserts provided by the manufacturers that guide clinicians in the use of a new drug. Because clinical trials are vital to the effective and safe use of new drugs, it is important to understand who participates in them, what questions are answered by clinical trials, and what questions are raised. The reader who asks the proper questions about issues such as methodology, affiliations of the investigators; statistical analyses performed, location of study centers, and study populations will derive the most information from the report of a clinical trial.

AB - Clinical trials support the efficacy and safety of new drags on the market. They provide the United States Food and Drug Administration with the information needed to approve an Investigational New Drug application and are the basis for package inserts provided by the manufacturers that guide clinicians in the use of a new drug. Because clinical trials are vital to the effective and safe use of new drugs, it is important to understand who participates in them, what questions are answered by clinical trials, and what questions are raised. The reader who asks the proper questions about issues such as methodology, affiliations of the investigators; statistical analyses performed, location of study centers, and study populations will derive the most information from the report of a clinical trial.

UR - http://www.scopus.com/inward/record.url?scp=0031712843&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031712843&partnerID=8YFLogxK

M3 - Review article

C2 - 9766614

AN - SCOPUS:0031712843

VL - 59

SP - 10

EP - 16

JO - Journal of Clinical Psychiatry

JF - Journal of Clinical Psychiatry

SN - 0160-6689

IS - SUPPL. 12

ER -