Book Search
1-2 of 2 results for Author: venky gopalaswamy (sorted by Publication Date, showing all)
-
Regulatory Challenges and Successful Product Development
By Smita Gopalaswamy, Venky Gopalaswamy
The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by...
Published April 21st 2008 by CRC Press
-
By Jose Justiniano, Venky Gopalaswamy
For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm...
Published November 14th 2004 by CRC Press
object(stdClass)#96 (3) {
["hits"]=>
array(2) {
[0]=>
object(stdClass)#97 (16) {
["bindingStyleCode"]=>
string(4) "HARD"
["categories"]=>
array(6) {
[0]=>
string(6) "BUS06A"
[1]=>
string(6) "SCEC02"
[2]=>
string(7) "BIO01D5"
[3]=>
string(10) "SCEB036035"
[4]=>
string(8) "SCBS6213"
[5]=>
string(7) "PHR03I5"
}
["edition"]=>
int(1)
["id"]=>
int(188495)
["imprint"]=>
string(9) "CRC Press"
["isbn"]=>
string(13) "9781420064469"
["isbn10"]=>
string(10) "1420064460"
["keywords"]=>
string(78) "SUCCESSFUL SUCC PRODUCTS DEVELOPMENT PRODUCT COMBINATION CHALLENGES REGULATORY"
["originators"]=>
array(2) {
[0]=>
object(stdClass)#98 (3) {
["id"]=>
int(3053316)
["name"]=>
string(17) "Smita Gopalaswamy"
["roleCode"]=>
string(2) "VE"
}
[1]=>
object(stdClass)#99 (3) {
["id"]=>
int(3053317)
["name"]=>
string(17) "Venky Gopalaswamy"
["roleCode"]=>
string(2) "VE"
}
}
["publicationDate"]=>
string(25) "2008-04-21T19:00:00-05:00"
["relevance"]=>
float(9.754878)
["shortDescription"]=>
string(298) "The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by"
["sku"]=>
string(5) "64460"
["subjectGroup"]=>
string(9) "Reference"
["subtitle"]=>
string(56) "Regulatory Challenges and Successful Product Development"
["title"]=>
string(20) "Combination Products"
}
[1]=>
object(stdClass)#100 (15) {
["bindingStyleCode"]=>
string(4) "HARD"
["categories"]=>
array(4) {
[0]=>
string(6) "PHR03S"
[1]=>
string(5) "MAT05"
[2]=>
string(8) "SCEC0230"
[3]=>
string(8) "SCPC1310"
}
["edition"]=>
int(1)
["id"]=>
int(194902)
["imprint"]=>
string(9) "CRC Press"
["isbn"]=>
string(13) "9780849321054"
["isbn10"]=>
string(10) "0849321050"
["keywords"]=>
string(31) "DESIGN DEVICE SIGMA MEDICAL SIX"
["originators"]=>
array(2) {
[0]=>
object(stdClass)#101 (3) {
["id"]=>
int(3037609)
["name"]=>
string(15) "Jose Justiniano"
["roleCode"]=>
string(2) "VE"
}
[1]=>
object(stdClass)#102 (3) {
["id"]=>
int(3037610)
["name"]=>
string(17) "Venky Gopalaswamy"
["roleCode"]=>
string(2) "VE"
}
}
["publicationDate"]=>
string(25) "2004-11-14T19:00:00-05:00"
["relevance"]=>
float(8.091848)
["shortDescription"]=>
string(298) "For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm"
["sku"]=>
string(6) "PH2105"
["subjectGroup"]=>
string(9) "Reference"
["title"]=>
string(35) "Six Sigma for Medical Device Design"
}
}
["query"]=>
object(stdClass)#103 (5) {
["bindingPriority"]=>
string(54) "PAPE,HARD,PCK,PKCC,PKCD,PKWE,EBK,DVD,CDRM,AUDC,WEB,AUD"
["size"]=>
int(10)
["sort"]=>
object(stdClass)#104 (2) {
["key"]=>
string(21) "SortByPublicationDate"
["direction"]=>
string(10) "Descending"
}
["start"]=>
int(1)
["suggestSpelling"]=>
bool(false)
}
["totalHits"]=>
int(2)
}
