ADIS R&D INSIGHT [107,907]

HOME : Support : Dialog Search Aids : Bluesheets
View Bluesheets by \| Database Name \| File Number \| Subject \| OneSearch Categories \| Search Options \|

	107,907
Adis R&D Insight

Last Loaded on Web: Wednesday, May 01, 2013

Last Update To Bluesheet: December 17, 2009

Bluesheet Contents PDF version

File Description	Dialog File Data	Special Features	Terms and Conditions	Additional Indexes	Map
Subject Coverage	Document Types Indexed	DIALINDEX/OneSearch Categories	Sample Record	Sort	Predefined Format Options
Tips	Geographic Coverage	Contact	Basic Index	Rank	Rates

File Description [top]

Adis R&D Insight comprehensively reports on the latest developments of drugs in active research and development internationally each week. More than 25,000 drugs are included in the database. Drugs reported in Adis R&D Insight start with the earliest laboratory report and continue through to world market launch. Every scientific or commercial development advancing the drug's progress to market is assessed, evaluated, and reported in Adis R&D Insight.

Adis R&D Insight is compiled from information collected from many sources. The primary sources are: direct contact with companies involved with research and development, information collected from drug and therapeutic literature published in more than 2,300 medical and biomedical journals, attendance at international meetings and conferences, company annual reports, news services, press releases, and licensed Lehman Brothers' PharmaPipelines data.

Adis editors check all the information before reporting in R&D Insight to ensure the integrity and timeliness of the published information.

File 107 is the public file; File 907 is the subscriber file, available to those who subscribe to a qualifying Wolters Kluwer Pharma Solutions product.

Tips [top]

USE FILE 107

to find R&D information on drug research from laboratory discovery to launch.

USE MAP

to extract CAS® Registry Numbers for searching in other pharmaceutical databases:

MAP RN TEMP

EXPAND ON DP=

to choose a developmental phase:

EXPAND DP=PHASE III

ENTER HELP CODES 107

to see WHO ATC and EphMRA ATC codes.

ENTER HELP EVAL 107

to find definitions of Adis Evaluation.

Subject Coverage [top]

Information reported in Adis R&D Insight includes: generic name, synonyms, brand names, developing companies, development phases by indication and country, adverse events, pharmacology, pharmacokinetics, pharmacodynamics, therapeutic trials, development history, licensed forecast information from Lehman Brothers, and Adis's own unique therapeutic value rating. Adis R&D Insight profiles are also backed by more than 10,000 evaluated Adis scientific summaries and 63,000 bibliographic references.

Dialog File Data [top]

Dates Covered:	1986 to present
File Size:	25,000+ records as of December 2009 (File 107) and 25,000+ records as of December 2009 (File 907)
Update Frequency:	Weekly

Document Types Indexed [top]

Reports

Geographic Coverage [top]

International

Geographic Restrictions [top]

None

Special Features [top]

ERA Available
KWIC and HILIGHT Available
DIALOG Alert Available
MAP Available

DialIndex/OneSearch Categories [top]

ACRONYM	CATEGORY NAME
ADIS	Adis Files
BRANDNMS	Brand Names
CASREGNO	CAS(R) Registry Numbers-Chemical and Medical Files
DRUGDEV	Drug Development Pipeline
DRUGDIR	Drug Directories
PHARM	Pharmacology
PHARMR	Pharmacology + RINGDOC-Files
PHARMREG	Pharmaceutical Regulation

Contact [top]

Adis R&D Insight is provided by Wolters Kluwer Pharma Solutions. Questions concerning file content should be directed to:

Wolters Kluwer Pharma Solutions
Client Services Department
770 Township Line Road, Suite 300
Yardley, PA 19067

Telephone:	+1-267-757-3421 ex 1
800 Line:	1-877-872-2347 ex 1
Fax:	+1-267-757-0652
E-Mail:	sarah.schweer@wolterskluwer.com

Wolters Kluwer Pharma Solutions
Client Services Department
250 Waterloo Road
London, SE1 8RD
United Kingdom

Telephone:	+44 20 7981 0764
Fax:	+44 20 7981 0564
E-Mail:	sarah.schweer@wolterskluwer.com

Terms and Conditions [top]

For Dialog's Redistribution and Archive Policy, enter HELP ERA online. The following terms and conditions also apply.

Database copyrighted by Adis Data Information BV. Data may not be duplicated in hard copy or machine-readable format without written permission of Adis Data Information BV.

If data is to be distributed under Dialog's Redistribution and Archiving (ERA) policy, distribution is restricted to the company and geographical boundaries of the country where the data was downloaded. Data which has been downloaded under this provision may not be sold or resold to a third pary outside the company organization.

Dialog Standard Terms & Conditions apply.

SAMPLE RECORD [top]

	`DIALOG(R)File 107:Adis R&D Insight`
	`(c) 2009 Wolters Kluwer Pharma Sol. All rts reserv`

AA=	`00244846 014306`
/NA,NA=	`Drug Name: Ezetimibe/simvastatin`
/TN,TN=
RD=	`Record Revision Date: 20050323`

/NA,NA=	`Brand Name: Inegy(TM); Vytorin(TM); Zintrepid(TM)`

/NA,NA=	`Synonyms: Simvastatin/ezetimibe; Zetia(TM)/Zocor sup((R)); Zocor sup((R))/ Zetia(TM)`
/SY,SY=

/NA,NA=	`Chemical Name: 1-(4-Fluorophenyl)-3(R)-(3(S)-(4-fluorophenyl)-3- hydroxypropyl)-4(S)-`
/CN,CN=	`(4-hydroxyphenyl)azetidin-2-one compd. with Butanoic acid, 2,2-dimethyl-, 1,2,3,7,8,8a-`
	`hexahydro-3,7- dimethyl-8-(2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl)-1- naphthalenyl`
	`ester,(1S-(1alpha,3alpha,7beta,8beta(2S,-4S),8abeta))-`

MF=	`Molecular Formula: C49H59F2NO8`
DR=,RN=	`Related CAS® Registry Number: 163222-33-1; 163380-16-3 ((3R-(3alpha(R*),4beta))-`
	`isomer); 79902-63-9`

AC=	`WHO ATC Code: C10A - Cholesterol and Triglyceride Reducers; C10A-A01 - Simvastatin`
CC=	`EPHMRA ATC Code: C10 - Hypolipidaemics/Anti-Atheroma Preparations; C10A - Cholesterol and`
	`Triglyceride Reduction Preparations; C10A1 - HMG CoA reductase inhibitors`
ME=	`Mechanism of Action: HMG-CoA reductase inhibitors; Reductase inhibitors; Oxidoreductase`
	`inhibitors; Enzyme inhibitors; Cholesterol absorption inhibitors`

/CO,CO=	`Originator Company: Merck/Schering-Plough Pharmaceuticals (USA)`
/LO,LO=
/CO,CO=	`Parent Company: Merck & Co - Schering-Plough (JV)`
/IP,IP=

DP=	`Highest Phase: Launched`

/ST,ST=	`Development Status: Launched, Germany, Hypercholesterolaemia`
	`Launched, Mexico, Hypercholesterolaemia`
	`Launched, USA, Hypercholesterolaemia`
	`Registered, European Union, Hypercholesterolaemia`
	`Preregistration, New Zealand , Hypercholesterolaemia`
	`Phase III, USA, Acute coronary syndromes`

/TX,/IT	`Text:`
	`Introduction:`
	`Schering-Plough and Merck & Co. have formed a joint venture, Merck/Schering-Plough`
	`Pharmaceuticals, to develop and market ezetimibe and simvastatin as a once-daily fixed-`
	`combination tablet (Vytorin(TM), Zintrepid(TM), Inegy(TM)). It is proposed that the`
	`combination tablet will be developed for all four doses of simvastatin (10-40mg). Ezetimibe`
	`is a cholesterol-absorption inhibitor, whereas simvastatin decreases endogenous liver`
	`production of cholesterol by inhibiting HMG-CoA reductase. Combination of these two different`
	`cholesterol-lowering mechanisms could achieve additive or synergistic`
	`cholesterol-lowering effects. In September 2001, Merck Sharp & Dohme in Singapore opened a`
	`manufacturing facility and the plant manufactures the ezetimibe/simvastatin fixed dose tablets.`
	`(...)`

/CS,/TX	`Commercial Summary: High cholesterol levels / Cholesterol absorption inhibitor`
	`----------------------------------------------------------------------`
	`Company Region Launch Date Peak Sales Patent Expiry`
	`----------------------------------------------------------------------`
	`Merck US 2004 $2800m`
	`Merck ex-US 2004 $1000m`
	`Schering Plough US 2004 $2800m`
	`Schering Plough ex-US 2004 $1000m`
	`----------------------------------------------------------------------`
	`Copyright (C) Lehman Brothers International. All rights reserved.`

/EV,SC=,EV=	`ADIS Evaluation:`
	`Hypercholesterolaemia 72 (PO).`







/TX,PO=	`Pharmacology Overview:`

	`Pharmacodynamics:`
	`Immunogenicity:`
	`Mechanism of action:`
	`HMG-CoA reductase inhibitors`
	`Reductase inhibitors`
	`Oxidoreductase inhibitors`
	`Enzyme inhibitors`
	`Cholesterol absorption inhibitors`
	`Activity versus parent drug: unspecified parent`

/TX,/CV	`Clinical Overview:`
	`Route(s) of Administration: PO`
	`Administration Freq.(per day):`
	`Adverse events:`
	`rare: Elevated aminotransferase levels, Hepatitis, Musculoskeletal pain, Pancreatitis,`
	`Rhabdomyolysis, Thrombocytopenia.`
	`Drug Interactions:`
	`Unknown. No interaction between ezetimibe and simvastatin in volunteers with LDL cholesterol`
	`levels > 130 mg/dl`

/TX,/AE	`Adverse Events:`
	`Comparative studies: ezetimibe/simvastatin was well tolerated with an overall safety profile`
	`similar to atorvastatin monotherapy among 788 patients with hypercholesterolaemia in a 24-week,`
	`randomised, placebo- controlled, phase III study. There were no clinically or statistically`
	`significant differences in the incidence of muscle enzyme elevations or consecutive liver`
	`(...)`

	`Drug Interactions:`
	`Ezetimibe did not affect the pharmacokinetics of simvastatin in a placebo-controlled phase I`
	`study. In this trial, volunteers with LDL cholesterol levels > 130 mg/dl (n = 58) were`
	`randomised to receive treatment PO od d1-14 with simvastatin 10mg with or without ezetimibe`
	`0.25, 1 or 10mg. There were no significant differences in C sub(max), AUC and CL/F between`
	`treatment groups/11/.`

	`Pharmacokinetics:`
	`Pharmacodynamics (Hyperlipidaemia):`
	`In a study, 24 volunteers with LDL cholesterol levels > 130 mg/dL were randomised to receive`
	`ezetimibe 10mg, simvastatin 20mg, or a combination of the two, for 14 days. The`
	`coadministration of ezetimibe and simvastatin was well tolerated and decreased LDL-cholesterol`
	`and total cholesterol, compared with simvastatin or ezetimibe alone/12/.`

/TX,/TR	`Therapeutic Trials:`
	`Hyperlipidaemia:`
	`The efficacy and safety of ezetimibe and simvastatin co-administration was assessed in 100`
	`patients with heterozygous familial hypercholesterolaemia, coronary heart disease, or multiple`
	`cardiovascular risk factors. While on simvastatin 20 mg/day, patients were randomised to`
	`(...)`

/UP,UP=	`Drug Update Information:`
	`10-Feb-2003: A clinical study hasbeen added to the Hyperlipidaemia pharmacodynamics section (924160)`
	`14-Dec-2001: Investigation in Hypercholesterolaemia in USA (PO)`
	`13-Dec-2001: Financial Figures have been added`
	`04-Dec-2001: Sales forecasts reviewed by Lehman Brothers`
	`26-Jul-2000: Investigation in Hypercholesterolaemia in USA (PO)`
	`26-Jul-2000: New profile`

/CR,CR=	`References:`
	`1. Merck/Schering-Plough Pharmaceuticals. Merck/Schering-Plough Pharmaceuticals Announces Submission of New Drug`
	`Application to FDA for Ezetimibe/Simvastatin Tablet, an Investigational Cholesterol-Lowering Medicine. Media`
	`Release. : 17 Nov 2003. Available from: URL: http://www.merck.com. (English).`
	`2. Schering-Plough Corporation. Schering-Plough Reports Financial Results for 2003 Fourth Quarter, Full Year. Media`
	`(...)`

XR=	`References No.: 800974093; 800974092; 800974094; 809041635; 800823732; 800934101; 809041121`

BASIC INDEX [top]

SEARCH SUFFIX	DISPLAY CODE	FIELD NAME	INDEXING	SELECT EXAMPLES
None	None	All Basic Index Fields	Word	S GERMANY
/AE	AE	Adverse Effects Text¹	Word	S ADVERSE(W)EVENT?/AE
/CN	CN	Chemical Name²	Word	S HYDROXYPHENYL(W)AZETIDIN/CN
/CO	CO	Company Name^2,3	Word	S MERCK(W)SCHERING/CO
/CR	CR	References²	Word	S ANNOUNCE?(W)SUBMISSION?/CR
/CS	CS	Commercial Summary¹	Word	S CHOLESTEROL(W)ABSORPTION/CS
/CV	CV	Clinical Overview¹	Word	S MUSCULOSKELETAL(W)PAIN/CV
/EV	EV	Adis Evaluation^2,4	Word	S HYPERCHOLESTEROLAEMIA(S)72/EV
/IP	IP	Parent Company Name²	Word	S MERCK/IP
/IT	IT	Introductory Text¹	Word	S CHOLESTEROL(W)LOWERING/IT
/LI	LI	Licensee²	Word	S ASTRA/LI
/LO	LO	Originator Company Name²	Word	S MERCK(W)SCHERING/LO
/NA	NA	Drug Name^2,5	Word & Phrase	S EZETIMIBE/NA S 'ZETIMIBE/SIMVASTATIN'/NA
/PC	PC	Pharmacology Text¹	Word	S RESISTANT(W)ENTEROCOCCI/PC
/PO	PO	Pharmacology Overview¹	Word	S REDUCTASE(W)INHIBITOR?/PO
/RR	RR	Related CAS Registry Numbers	Phrase	S 163222-33-1/RR
/ST	ST	Development Status²	Word	S BACTERIAL(W)INFECTIONS/ST
/SY	SY	Synonyms²	Word & Phrase	S ZETIA/SY S ZOCOR SUP?/SY
/TN	TN	Brand Name²	Word	S INEGY/TN
/TR	TR	Therapeutic Trial Text¹	Word	S CORONARY(W)HEART/TR
/TX	TX	Text⁶	Word	S LIVER(W)PRODUCTION/TX
/UP	UP	Drug Update Information²	Word	S CLINICAL(W)STUDY/UP

¹Also searchable and displayable with TX.

²Searchable in the Basic Index and in the Additional Indexes.

³Includes Originator, Parent Company, Other Companies, and Licensee.

⁴Enter HELP EVAL 107 to see descriptions online.

⁵Includes Brand Name, Chemical Name, and Synonyms.

⁶/TX includes: AE, CS, CV, IT, PC, PO, TR.

ADDITIONAL INDEXES [top]

SEARCH PREFIX	DISPLAY CODE	FIELD NAME	INDEXING	SELECT EXAMPLES
AA=	AA	IP Accession Number	Phrase	S AA=004877
AC=	AC	WHO ATC Codes and Descriptions⁷	Word & Phrase	S AC=(TRIGLYCERIDE(W)REDUCER) S AC='CHOLESTEROL AND TRIGLYCERIDE'?
AM=	PO	Active Metabolites	Phrase	S AM=NO
None	AN	DIALOG Accession Number
CC=	CC	EphMRA ATC Codes and Descriptions⁷	Word & Phrase	S CC=(REDUCTASE(W)INHIBITORS) S CC=C10A1
CC=	CC	EphMRA ATC Codes and Descriptions⁷	Phrase	S CC='HYPOLIPIDAEMICS/ANTI-ATHEROMA'?
CN=	CN	Chemical Name^2,11	Phrase	S CN=1-(4-FLUOROPHENYL)?
CO=	CO	Company Name^2,3	Phrase	S CO=MERCK & CO?
CR=	CR	References²	Word	S CR=(ANNOUNCE?(W)SUBMISSION?)
DP=	DP	Highest Phase of Development	Word & Phrase	S DP=LAUNCHED S DP=PHASE III
DR=	DR	Drug of Record CAS Number⁸	Phrase	S DR=163222-33-1
EL=	PO	Route of Elimination	Phrase	S EL=RENAL?
EV=	EV	Adis Evaluation^2,4	Phrase	S EV=HYPERCHOLESTROLAEMIA(S)72
IP=	IP	Parent Company Name²	Phrase	S IP=MERCK & CO - SCHERING?
LI=	LI	Licensee²	Phrase	S LI=ASTRA?
LK=	PO	Linear Kinetics	Phrase	S LK=YES
LO=	LO	Originator Company Name²	Phrase	S LO='MERCK/SCHERING'?
ME=	ME	Mechanism of Action	Word & Phrase	S ME=(REDUCTASE(W)INHIBITORS) S ME=CHOLESTEROL ABSORPTION?
MF=	MF	Molecular Formula	Phrase	S MF=C49H59F2NO8
NA=	NA	Drug Name^2,5	Phrase	S NA=ZINTREPID(TM)
RD=	RD	Record Revision Date^9,10	Phrase	S RD=20050323
RN=	RN	CAS(R) Registry Number¹²	Phrase	S RN=79902-63-9
SC=	SC	Adis Rating of Therapeutic Value	Numeric	S SC>=70(S)EV=HYPERCHOLESTEROLAEMIA
ST=	ST	Development Status²	Phrase	S ST=PREREGISTRATION NEW ZEALAND?
SY=	SY	Synonyms^2,11	Phrase	S SY=ZETIA(TM)?
TN=	TN	Brand Name^2,11	Phrase	S TN=INEGY(TM)
UD=	None	Update	Phrase	S UD=9999
UP=	UP	Drug Update Information²	Word	S UP=(FINANCIAL(W)FIGURES)
XR=	XR	Reference Number	Phrase	S XR=800974093

⁷Codes are assigned by Adis. Enter HELP CODES 107 to view codes online.

⁸Also is searchable as RN=

⁹Revision Date is changed only when there are significant changes in the content of the record.

¹⁰Also searchable as PD=

¹¹Also searchable as NA=

¹²Includes drug of record CAS Registry Number and Related CAS Registry Number.

SORT [top]

SORTABLE FIELDS	EXAMPLES
AC, CC, CO, LO, ME, NA, RD, SC	SORT S2/ALL/CC SORT S3/ALL/SC

RANK [top]

RANK FIELDS	EXAMPLES
All phrase- and numeric-indexed fields in the Additional Indexes can be ranked.	RANK CO S3

MAP [top]

MAP FIELDS	EXAMPLES
LO, NA, RN, SY, SYRN, XR	MAP NA TEMP S2 MAP SYRN TEMP S1

USER-DEFINED FORMAT OPTIONS [top]


User-defined formats can be specified using the display codes indicated in the Search Options tables.	TYPE S3/NA,AE,RR/1-5 PRINT S2/NA,SY,SC/ALL

PREDEFINED FORMAT OPTIONS [top]

NO.	DIALOGWEB FORMAT	RECORD CONTENT
1	--	DIALOG Accession Number
2	--	Drug Name, Synonyms, Brand Name, Chemical Name, Originator Company, Parent Company, Licensee, Other Company, Highest Phase, WHO ATC Codes, EphMRA ATC Codes, and Record Revision Date
3	Medium	Development Status, Adis Evaluation, Commercial Summary, Clinical Overview, Pharmacology Overview, Mechanism of Action, Introduction Text, and all information provided in Format 2
4	--	Full Record with Tagged Fields
5	--	Full Record
6	Free	Drug Name and Record Revision Date
7	Long	Full Record except CAS Registry Number, Related CAS Registry Number, Molecular Formula, References, and Reference Numbers
8	Short	Drug Name and Record Revision Date
9	Full	Full Record
K	--	KWIC (Key Word In Context) displays a window of text; may be used alone or with other formats

DIRECT RECORD ACCESS [top]

FIELD NAME	EXAMPLES
DIALOG Accession Number	TYPE 00123456/9 DISPLAY 00238215/5 PRINT 00654321/4

Rates [top]

Rates For File: Adis R&D Insight[107]
Cost per DialUnit:                $14.43
Cost per minute:                   $3.83
Rank Elements                      $0.00
ALERT (default)                    $8.50
ALERT (Monthly)                *  $22.00
ALERT (Biweekly/twice a month) *  $13.75
ALERT (Weekly)                     $8.50
ALERT (Daily)                  *   $8.50
ALERT (Calendar weekly)        *   $8.50
ALERT (Intraday)               *   $8.50
* = custom scheduled Alerts only
ALERT Number of included prints        0

Format    Types   Prints
     1    $0.00    $0.00
     2   $11.00   $11.00
     3   $23.00   $23.00
     4   $30.00   $30.00
     5   $30.00   $30.00
     6    $0.00    $0.00
     7   $23.00   $23.00
     8    $0.00    $0.00
     9   $30.00   $30.00
KWIC95    $3.00       NA
KWIC96    $3.00       NA

REDIST/COPY Multiplier Table:

      Range      Multiplier
        1-2       1.00
       3-25       1.50
     26-100       3.00
    101-200       4.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00

ARCHIVE Multiplier Table:

      Range      Multiplier
       1-25       1.50
     26-200       3.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00

Rates For File: Adis R&D Insight - subscribers[907]
Cost per DialUnit:                $14.00
Cost per minute:                   $3.83
Rank Elements                      $0.00
ALERT (default)                    $8.50
ALERT (Monthly)                *  $22.00
ALERT (Biweekly/twice a month) *  $14.00
ALERT (Weekly)                     $8.50
ALERT (Daily)                  *   $8.50
ALERT (Calendar weekly)        *   $8.50
ALERT (Intraday)               *   $8.50
* = custom scheduled Alerts only
ALERT Number of included prints        0

Format    Types   Prints
     1    $0.00    $0.00
     2    $4.00    $4.00
     3    $4.00    $4.00
     4    $4.00    $4.00
     5    $4.00    $4.00
     6    $0.00    $0.00
     7    $4.00    $4.00
     8    $0.00    $0.00
     9    $4.00    $4.00
KWIC95    $0.40       NA
KWIC96    $0.40       NA

REDIST/COPY Multiplier Table:

      Range      Multiplier
        1-2       1.00
       3-25       1.50
     26-100       3.00
    101-200       4.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00

ARCHIVE Multiplier Table:

      Range      Multiplier
       1-25       1.50
     26-200       3.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00

[top]