Screening of new BACE‐1 inhibitors from marine animals: Molecular interaction and pharmacokinetic studies to find new drug prototypes

Japanese Guidance on Clinical Pharmacokinetic Studies and Review of the New Drug Applications.

10.2133/dmpk.16.187 ◽

2001 ◽

Vol 16 (3) ◽

pp. 187-192

Author(s):

Naomi NAGAI

Keyword(s):

Pharmacokinetic Studies ◽

New Drug

A survey of hepatic impairment pharmacokinetic studies for new drug approvals and proposal for the setting of the criteria for hepatic impairment

Proceedings for Annual Meeting of The Japanese Pharmacological Society ◽

10.1254/jpssuppl.wcp2018.0_po1-11-23 ◽

2018 ◽

Vol WCP2018 (0) ◽

pp. PO1-11-23

Author(s):

Sumire Shimada ◽

Megumi Inoue ◽

Kimio Terao

Keyword(s):

Hepatic Impairment ◽

Pharmacokinetic Studies ◽

New Drug ◽

Drug Approvals

Role of the Pharmacokinetic Data in the Evaluation of New Drug and the Purpose of the Revision of the Japanese Guidelines on Non-clinical Pharmacokinetic Studies.

10.2133/dmpk.12.235 ◽

1997 ◽

Vol 12 (3) ◽

pp. 235-239

Author(s):

Yasuo OHNO

Keyword(s):

Pharmacokinetic Studies ◽

Pharmacokinetic Data ◽

New Drug ◽

Japanese Guidelines

Proposal against New Guidlines for Nonclinical Pharmacokinetic Studies From Viewpoint of New Drug Development.

10.2133/dmpk.12.240 ◽

1997 ◽

Vol 12 (3) ◽

pp. 240-247

Author(s):

Toru HORIE

Keyword(s):

Drug Development ◽

Pharmacokinetic Studies ◽

New Drug ◽

New Drug Development

Pharmacokinetic Studies in Healthy Subjects for the Development of an Extended-Release Tablet Formulation of Guaifenesin: A 505(b)(2) New Drug Application Approval

Clinical Pharmacology in Drug Development ◽

10.1002/cpdd.8 ◽

2013 ◽

Vol 2 (1) ◽

pp. 25-32 ◽

Cited By ~ 3

Author(s):

Lineau Vilson ◽

Joel S. Owen

Keyword(s):

Healthy Subjects ◽

Extended Release ◽

Drug Application ◽

Tablet Formulation ◽

Pharmacokinetic Studies ◽

New Drug ◽

New Drug Application ◽

Extended Release Tablet ◽

Release Tablet

Proposal against New Guidelines for Nonclinical Pharmacokinetic Studies from Viewpoint of New Drug Development

10.2133/dmpk.11.supplement_5136 ◽

1996 ◽

Vol 11 (supplement) ◽

pp. 5136-5137

Author(s):

Toru HORIE

Keyword(s):

Drug Development ◽

Pharmacokinetic Studies ◽

New Drug ◽

New Drug Development ◽

New Guidelines

Guidance on Clinical Pharmacokinetic Studies and Review of the New Drug Application

10.2133/dmpk.15.supplement_146 ◽

2000 ◽

Vol 15 (supplement) ◽

pp. 146-147

Author(s):

Naomi NAGAI

Keyword(s):

Drug Application ◽

Pharmacokinetic Studies ◽

New Drug ◽

New Drug Application

Impact of “Guidance for Industry: Clinical Pharmacokinetic Studies of Pharmaceuticals” on New Drug Approvals of Central Nervous System Drugs in Japan

10.2133/dmpk.dmpk-08-cm-054 ◽

2011 ◽

Vol 26 (1) ◽

pp. 117-120 ◽

Cited By ~ 1

Author(s):

Susumu Nakade ◽

Junsaku Kitagawa ◽

Tomoya Ohno ◽

Chihiro Amano ◽

Naoki Honda ◽

...

Keyword(s):

Central Nervous System ◽

Nervous System ◽

Pharmacokinetic Studies ◽

Central Nervous System Drugs ◽

New Drug ◽

Drug Approvals

A Survey of Clinical Pharmacokinetic Studies of 17 Cardiovascular Drugs in Japanese New Drug Approvals Between 2000 and 2007

Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics ◽

10.3999/jscpt.40.287 ◽

2009 ◽

Vol 40 (6) ◽

pp. 287-293

Author(s):

Susumu NAKADE ◽

Akinori YAMAUCHI ◽

Naoki HONDA ◽

Junsaku KITAGAWA ◽

Tomoya OHNO ◽

...

Keyword(s):

Cardiovascular Drugs ◽

Pharmacokinetic Studies ◽

New Drug ◽

Drug Approvals

Recent Trend of Pharmacokinetic Studies in New Drug Development

Journal of the Mass Spectrometry Society of Japan ◽

10.5702/massspec.56.139 ◽

2008 ◽

Vol 56 (3) ◽

pp. 139-142

Author(s):

Kazuhide IWASAKI

Keyword(s):

Drug Development ◽

Recent Trend ◽

Pharmacokinetic Studies ◽

New Drug ◽

New Drug Development