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5c1c13d314e1ca84500ed18a9ad19b200afacfd39b9587ddcc941a0d0a450b2a
|
What is the number written above TAK-INDNDA-01577086?
Give a very brief answer.
|
425.
|
docvqa
|
|
5c1c13d314e1ca84500ed18a9ad19b200afacfd39b9587ddcc941a0d0a450b2a
|
What is the contact number of Ms. Jena Weber, Regulatory Project Manager?
Ensure brevity in your answer.
|
301-827-6422.
|
docvqa
|
|
5c1c13d314e1ca84500ed18a9ad19b200afacfd39b9587ddcc941a0d0a450b2a
|
What is the full form of ODE?
Give a very brief answer.
|
Office of Drug Evaluation.
|
docvqa
|
|
5c1c13d314e1ca84500ed18a9ad19b200afacfd39b9587ddcc941a0d0a450b2a
|
What is written above Page 2 on the top?
Keep it short and to the point.
|
IND 33, 729.
|
docvqa
|
|
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
|
What is the unit mentioned in the letter ?
Provide a succinct answer.
|
7200.
|
docvqa
|
|
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
|
What is the date mentioned
Your response must be concise.
|
9/23/93.
|
docvqa
|
|
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
|
Name of the first person in the To list?
Offer a very short reply.
|
Pj daniels.
|
docvqa
|
|
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
|
From whose desk this letter is written ?
Offer a terse response.
|
Timothy j gumbleton.
|
docvqa
|
|
3b817505b6b719598950d2a33ab77016a4ff7ef76a599751c368718e74f70b89
|
Whose letter's copy is attached?
Your response must be concise.
|
DR. Mitchell.
|
docvqa
|
|
137d6af0b95a26d575a6f170d2cd4f7b456570f6620b51e2aee6fc526e68f170
|
What is the date mentioned ?
Make the answer very short.
|
February 6 , 1996.
|
docvqa
|
|
137d6af0b95a26d575a6f170d2cd4f7b456570f6620b51e2aee6fc526e68f170
|
To whom this letter is written ?
Provide a succinct answer.
|
Dr. K. KItazawa.
|
docvqa
|
|
137d6af0b95a26d575a6f170d2cd4f7b456570f6620b51e2aee6fc526e68f170
|
This letter is written by whom ?
Make the answer very short.
|
T. Suzuki.
|
docvqa
|
|
137d6af0b95a26d575a6f170d2cd4f7b456570f6620b51e2aee6fc526e68f170
|
Which laboratory is T. Suzuki associated with ?
Offer a very short reply.
|
Drug safety research laboratories .
|
docvqa
|
|
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
|
What is the date mentioned in the letter
Give a very brief answer.
|
August 8 , 2002.
|
docvqa
|
|
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
|
What is the name of the industry given here?
Make the answer very short.
|
Takeda chemical industries, LTD .
|
docvqa
|
|
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
|
To whom this letter is written ?
Keep it short and to the point.
|
Dr. Thom.
|
docvqa
|
|
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
|
What is the name mentioned in cc
Offer a terse response.
|
Mr . S . Hamanaka.
|
docvqa
|
|
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
|
Who sent this letter?
Your response must be concise.
|
Katsuhisa Saito.
|
docvqa
|
|
7841c857cc2aa66a8c2908971befd2d4112e373ff15c6562c96a17cead7f0191
|
What is ref: code mentioned ?
Give a very brief answer.
|
TPNA-TS-020808.
|
docvqa
|
|
e7c85417d65fb2b88d67b9cab110134b28667834acc6fe2a8263ddd0d7aa5756
|
What is the venue mentioned in the document?
Your answer should be very brief.
|
TPNA, Chicago.
|
docvqa
|
|
e7c85417d65fb2b88d67b9cab110134b28667834acc6fe2a8263ddd0d7aa5756
|
What is the date mentioned in the document?
Offer a terse response.
|
Monday, 12 and Tuesday, 13 August 2002.
|
docvqa
|
|
e7c85417d65fb2b88d67b9cab110134b28667834acc6fe2a8263ddd0d7aa5756
|
What is the fax number mentioned in the letter at the top?
Provide a succinct answer.
|
06 6204 2244.
|
docvqa
|
|
e7c85417d65fb2b88d67b9cab110134b28667834acc6fe2a8263ddd0d7aa5756
|
Which drug's toxicity study results will be discussed ?
Make the answer very short.
|
Pioglitazone.
|
docvqa
|
|
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
|
What is the date and time mentioned ?
Provide a succinct answer.
|
10/27/93 09:36:07.
|
docvqa
|
|
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
|
What is mentioned in the subject ?
Offer a terse response.
|
Pioglitazone statement.
|
docvqa
|
|
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
|
To whom this email was send?
Offer a terse response.
|
PETER J. DANIELS.
|
docvqa
|
|
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
|
What is the date mentioned in the forwarding note ?
Offer a terse response.
|
10/26/93 15:44.
|
docvqa
|
|
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
|
What is the time mentioned in the forwarding note ?
Give a very brief answer.
|
15:44.
|
docvqa
|
|
e7499dbbbca5135763b34f462e7aef7b15f0c9d009a19a79988c77531e9b6330
|
To whom this email was forwaded?
Give a very brief answer.
|
PLRUPPEL--RCC1 RUPPEL, PATRICIA.
|
docvqa
|
|
cc353e21b51a7b66a083a05f0899245ff1db02e7acc7a2ec10f21b81163ee296
|
What is the name of the company
Offer a terse response.
|
THE UPJOHN COMPANY.
|
docvqa
|
|
cc353e21b51a7b66a083a05f0899245ff1db02e7acc7a2ec10f21b81163ee296
|
What is the date and year mentioned ?
Your answer should be very brief.
|
September 21, 1993.
|
docvqa
|
|
cc353e21b51a7b66a083a05f0899245ff1db02e7acc7a2ec10f21b81163ee296
|
Which company is mentioned in the letterhead?
Provide a short and direct response.
|
THE UPJOHN COMPANY.
|
docvqa
|
|
cc353e21b51a7b66a083a05f0899245ff1db02e7acc7a2ec10f21b81163ee296
|
In which country the upjohn company is located ?
Give a very brief answer.
|
U.S.A.
|
docvqa
|
|
fbd88b7577c4e860b7847d238709545b6b829426d3fdd438a7506d89f44d56eb
|
What is the fax mentioned ?
Provide a succinct answer.
|
06 6204 2244.
|
docvqa
|
|
fbd88b7577c4e860b7847d238709545b6b829426d3fdd438a7506d89f44d56eb
|
What is year date and time mentioned?
Make the answer very short.
|
2002 08/08 21:49.
|
docvqa
|
|
fbd88b7577c4e860b7847d238709545b6b829426d3fdd438a7506d89f44d56eb
|
What is the name of the division ?
Make the answer very short.
|
Takeda Develop division.
|
docvqa
|
|
fbd88b7577c4e860b7847d238709545b6b829426d3fdd438a7506d89f44d56eb
|
To whom they can ask directly to disclose the details of "promotion study"?
Make the answer very short.
|
FDA.
|
docvqa
|
|
986a7319cafc460ff805f2a4134db11156cdce345cf50b1bccc7b0008f3201be
|
What is the date mentioned in the letter
Ensure brevity in your answer.
|
8 january 2003.
|
docvqa
|
|
986a7319cafc460ff805f2a4134db11156cdce345cf50b1bccc7b0008f3201be
|
To whom this letter is addressed?
Give a very brief answer.
|
MPDRAP I Leader.
|
docvqa
|
|
986a7319cafc460ff805f2a4134db11156cdce345cf50b1bccc7b0008f3201be
|
What is mentioned in the cc?
Your answer should be very brief.
|
CEOs and General Managers of Pharmaceutical Units.
|
docvqa
|
|
986a7319cafc460ff805f2a4134db11156cdce345cf50b1bccc7b0008f3201be
|
Combination therapy in the us market accounts for how much % of total actos sales .
Make the answer very short.
|
64.
|
docvqa
|
|
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
|
What is the due date to evaluate data from actos 507?
Give a very brief answer.
|
August 5.
|
docvqa
|
|
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
|
Who is the lead responsibility for developing additional monitoring plan for actos 508
Your response must be concise.
|
Amy hagaman.
|
docvqa
|
|
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
|
What is the due date for "draft justification for actos 508" ?
Offer a very short reply.
|
August 12.
|
docvqa
|
|
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
|
When was this last updated ?
Ensure brevity in your answer.
|
August 1, 2002.
|
docvqa
|
|
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
|
Who is the lead responsible person for draft justification for actos 508?
Provide a succinct answer.
|
Amy Hagaman/Alfonso Perez.
|
docvqa
|
|
e3889dedcc8c42890cc5c4c3a76f822607d682ae5634a99d1b2594b4c682fb02
|
How many pages are there in total as part of this document?
Offer a terse response.
|
7.
|
docvqa
|
|
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
|
Which is the core organization of Takeda pharmaceutical Company?
Your answer should be compact.
|
Pharmaceutical development Division.
|
docvqa
|
|
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
|
Who made the opening remarks ?
Your answer should be compact.
|
Dr. Kitazawa.
|
docvqa
|
|
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
|
When is the clinical expert meeting scheduled?
Your response must be concise.
|
October 1 and 2.
|
docvqa
|
|
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
|
Why was it suggested to prepare non-clinical "White paper"?
Make the answer very short.
|
To address the bladder issue.
|
docvqa
|
|
dd17528fdf309aec4ac3609d484926a5bf820cf93af2709f913dcb2624d3886a
|
What is Ms Wakamatsu's role in Dept. Strategic Development?
Give a very brief answer.
|
Assistant manager.
|
docvqa
|
|
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
|
What is the date mentioned in the given information ?
Your answer should be very brief.
|
20 April 2006.
|
docvqa
|
|
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
|
What is the meeting time mentioned here?
Offer a terse response.
|
4:00pm - 5:00pm.
|
docvqa
|
|
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
|
What is the place mentioned ?
Make the answer very short.
|
Meeting room 403.
|
docvqa
|
|
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
|
Who will forward the article regarding rosiglitazone and non clinical bladder data to andy ?
Your answer should be very brief.
|
Mondira.
|
docvqa
|
|
6ada9f853a6d2f11603c0807dc306143f874d17d9e592a3df8e83578669f04cf
|
What date is the meeting scheduled to develop the overall structure of the document?
Make the answer very short.
|
In early may.
|
docvqa
|
|
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
|
Who presented an outline of the Cohen hypothesis?
Your answer should be compact.
|
Philip Collett.
|
docvqa
|
|
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
|
What is significant in the development of calculi?
Your response must be concise.
|
Raising the pH of male rat urine above 6.5.
|
docvqa
|
|
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
|
What is the correlation observed in cohen's paper?
Ensure brevity in your answer.
|
0.61.
|
docvqa
|
|
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
|
Why didn't rats eliminate calculi as humans do?
Provide a short and direct response.
|
Because rats are quadropeds.
|
docvqa
|
|
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
|
Who challenged authorities regrading implementing monitoring plan?
Your answer should be very brief.
|
Takeda Europe.
|
docvqa
|
|
e37155b5e153878a1f9a0ac3310bfcf07d12187e59e5681cbc3e2a54dbbe6580
|
What content is high in male rat urine?
Give a very brief answer.
|
Protien content.
|
docvqa
|
|
1e169aa541822dc98eccc16d6dd778cdce30cc9af9e566bdff25b38411d59c48
|
What is the fullform of MAA?
Ensure brevity in your answer.
|
Marketing Authorization Application.
|
docvqa
|
|
1e169aa541822dc98eccc16d6dd778cdce30cc9af9e566bdff25b38411d59c48
|
Which forum is mentioned in this document?
Your answer should be very brief.
|
Takeda Global Risk Management Forum.
|
docvqa
|
|
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
|
What is the issued date of this document?
Make the answer very short.
|
August 13, 2002.
|
docvqa
|
|
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
|
Who is the Director of Nonclinical Safety and Efficacy?
Keep it short and to the point.
|
David Baron.
|
docvqa
|
|
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
|
Who described tumor promoter-model study?
Provide a succinct answer.
|
Dr. El-Hage.
|
docvqa
|
|
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
|
What is the duration of daily dosing?
Ensure brevity in your answer.
|
32-weeks after BBN.
|
docvqa
|
|
827223ec75540232069e94651d6b8b637e3ddc47740380584dda10c0d83bbea2
|
What is the exhibit number?
Give a very brief answer.
|
107.
|
docvqa
|
|
e86ffa9a9f68a374ffd8be9e09c1e4a78e513b1ce005a7ee78e629e0e082ef25
|
Who updated the CEO on August 6?
Provide a succinct answer.
|
Mr. Saito.
|
docvqa
|
|
e86ffa9a9f68a374ffd8be9e09c1e4a78e513b1ce005a7ee78e629e0e082ef25
|
By when should TPNA send outline of response to TCI ?
Offer a very short reply.
|
By august 19.
|
docvqa
|
|
e86ffa9a9f68a374ffd8be9e09c1e4a78e513b1ce005a7ee78e629e0e082ef25
|
When will Mr. Saito present outline to CEO?
Provide a short and direct response.
|
August 20.
|
docvqa
|
|
e86ffa9a9f68a374ffd8be9e09c1e4a78e513b1ce005a7ee78e629e0e082ef25
|
By when will the document be finalized?
Offer a terse response.
|
August 26.
|
docvqa
|
|
8ddbfdff7e9c5ec673146915c432be493e913e6a36410eddc4950fa730e43f08
|
When will the FDA Conference Call be held?
Provide a succinct answer.
|
July 31, 2002.
|
docvqa
|
|
8ddbfdff7e9c5ec673146915c432be493e913e6a36410eddc4950fa730e43f08
|
On the purpose of teleconference, how many topics were to be discussed?
Provide a succinct answer.
|
3 topics.
|
docvqa
|
|
8ddbfdff7e9c5ec673146915c432be493e913e6a36410eddc4950fa730e43f08
|
What is the date mentioned at the bottom?
Your response must be concise.
|
09/18/12.
|
docvqa
|
|
79463ad1324ef31cd1e4eba0f9f443d1db23035648a518a79dbff7aab00b7bf0
|
What is the heading of the document?
Provide a short and direct response.
|
ACTOS FDA RESPONSE TASK FORCE-TPNA.
|
docvqa
|
|
79463ad1324ef31cd1e4eba0f9f443d1db23035648a518a79dbff7aab00b7bf0
|
How many key issues does the FDA have with respect to the non-clinical data related to bladder tumors?
Your answer should be compact.
|
The FDA has 3 key issues with respect to the non-clinical data related to bladder tumors.
|
docvqa
|
|
79463ad1324ef31cd1e4eba0f9f443d1db23035648a518a79dbff7aab00b7bf0
|
What plan is developed by TPNA?
Provide a short and direct response.
|
TPNA will develop monitoring plan.
|
docvqa
|
|
79463ad1324ef31cd1e4eba0f9f443d1db23035648a518a79dbff7aab00b7bf0
|
What is TPNA's goal?
Ensure brevity in your answer.
|
Is to supply justification to support maintaining current labeling.
|
docvqa
|
|
7538f184d27f9026d6d315ee08bc9528d3553fdee0e0f2e1f05d8b91caa9774c
|
When was this document last updated?
Make the answer very short.
|
August 1, 2002.
|
docvqa
|
|
7538f184d27f9026d6d315ee08bc9528d3553fdee0e0f2e1f05d8b91caa9774c
|
What is the last point in the table?
Provide a short and direct response.
|
Evaluate Impact on Tak-559.
|
docvqa
|
|
7538f184d27f9026d6d315ee08bc9528d3553fdee0e0f2e1f05d8b91caa9774c
|
What is the Draft's Due Date?
Offer a very short reply.
|
August 5.
|
docvqa
|
|
650b6c6fa1dd620d0964dd539fdec18fd8ec253993d428b0f4436de9c5d4a998
|
What kind of meeting is mentioned in this letter?
Offer a terse response.
|
ACTOS FDA RESPONSE MEETING.
|
docvqa
|
|
650b6c6fa1dd620d0964dd539fdec18fd8ec253993d428b0f4436de9c5d4a998
|
What kind of drug is used to treat the group of rats?
Ensure brevity in your answer.
|
Pioglitazone.
|
docvqa
|
|
650b6c6fa1dd620d0964dd539fdec18fd8ec253993d428b0f4436de9c5d4a998
|
What kind of cell tumours experienced the same frequency when group of rats treated with pioglitazone?
Your response must be concise.
|
Transitional cell tumors.
|
docvqa
|
|
919c81ea5c4f02f134c4d968639f748c7d710d1a33c614c78475c737eccfa876
|
In the rat oncogenicity study, what was observed in male rats?
Give a very brief answer.
|
Thickening of the bladder and hypertrophy of the urothelium.
|
docvqa
|
|
919c81ea5c4f02f134c4d968639f748c7d710d1a33c614c78475c737eccfa876
|
What is the time span where no tumors are seen?
Your answer should be very brief.
|
Shorter term (12 month).
|
docvqa
|
|
919c81ea5c4f02f134c4d968639f748c7d710d1a33c614c78475c737eccfa876
|
According to mouse oncogenicity study, what was seen male mice only?
Your answer should be compact.
|
Hyperplasia.
|
docvqa
|
|
919c81ea5c4f02f134c4d968639f748c7d710d1a33c614c78475c737eccfa876
|
Who conducted robust program?
Your answer should be very brief.
|
TCI.
|
docvqa
|
|
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
|
What is the due date to conduct review meeting for FDA package?
Offer a very short reply.
|
August 22.
|
docvqa
|
|
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
|
Who is the lead responsible person for the compilation of FDA package?
Your answer should be compact.
|
Larry Hancock.
|
docvqa
|
|
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
|
What is the task assigned to David Baron?
Your answer should be compact.
|
Send nonclinical rationale/justification section to medical writing for compilation.
|
docvqa
|
|
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
|
Who is responsible for sending package to TCI/EU for review?
Offer a terse response.
|
Mary Ramstack.
|
docvqa
|
|
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
|
What is the due date for sending FDA Document to Regulatory Affairs?
Keep it short and to the point.
|
August 26.
|
docvqa
|
|
d193e0ca5bfbaca218b39d9874bd8bf8adafb81a333ecc47828b3820cf415866
|
What is the last updated date mentioned in this document?
Make the answer very short.
|
August 1, 2002.
|
docvqa
|
|
49899848bd18ca4b495deae7452c1ef406b0566d4692666a6ca6bd4b2650a6f7
|
Which product's liability claims are described here?
Make the answer very short.
|
ACTOS PRODUCTS.
|
docvqa
|
|
49899848bd18ca4b495deae7452c1ef406b0566d4692666a6ca6bd4b2650a6f7
|
What is the date mentioned in this document at the bottom?
Offer a very short reply.
|
1/11/2007.
|
docvqa
|
|
49899848bd18ca4b495deae7452c1ef406b0566d4692666a6ca6bd4b2650a6f7
|
What is the exhibit number?
Offer a very short reply.
|
52.
|
docvqa
|
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