Indian Institute Of Integrative Medicine Tender
Search from the latest JKtenders and find a business opportunity fitting your SME on the online platform of BidAssist. If you're wondering how to find the latest JK tenders or from where to get all the documents without the hassles, this is what we explain here. Find the best opportunities coming to the surface via the JK government, PSUs and state corporations.
Indian Institute Of Integrative Medicine - IIIM Tender
Healthcare and Medicine
Chemical Products
Eprocure
Opening Date4 Aug 2021
Closing Date19 Aug 2021
Tender AmountRefer Documents
Costs
EMD
Refer DocumentsDocument Cost
Refer DocumentsTender Fee
Refer Documents
Description
Scription for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user this is tender description for unregistered user
Contact
Tender Id
2021_CSIR_82311_2Bid Award Id
ViewTender No
12(317)/21-PTender Authority
Indian Institute Of Integrative Medicine ViewPurchaser Address
-Website
http://https://www.csir.res.in/
GEM & Bid Advisory Services
Get portal registration, tender bidding, product/service listing or vendor/MSME certification services at a nominal cost
Documents
BOQ Items
1. Development of prototypes formulation of Product-II
2. Compatibility studies with Excipients 3. Finalization of composition
4. Characterization and evaluation of capsule
5. Optimization of the formulation (Description of composition of product)
6. Description of Manufacturing process and flow chart (Manufacturing formula)
7. In process quality control checks and reports
8. Process validation of Pilot scale batches
9. Specifications for finished product (Release) test and procedures
10. Justification for specifications
11. Certificate of analysis (CoA) of respective batches
12. Stability specification
13. Analytical Method validation protocol & reports. The method which are to be intended use
14. Packing material identification pack presentation & product package interaction studies and stability studies (with HDPE bottle will contain 60 capsules) and specifications of packing material
15. Testing and evaluation of packing materials
16. Batch packing record
17. Labeling information
18. Stability data: Accelerated and Long term (24 months)
19. Compilation of the data in TTD.
20. Stability studies of APPI (accletated and long term)
Note: Phytopharmaceuticals are defined under definition of new drugs as per ND & CT Rules, 2019. Firm has to submit application in Form CT10/CT/12/CT-13 for permission for manufacturing of the test batches for conduct of the clinical trial before obtaining license in Form 29 from the respective state licensing authority.
3
-
-
PRECLINICALSTUDY PACKAGE-I
-
-
-
Product- I- Efficacy of Test compounds in rat model of bone cancer pain produced by breast cancer cells
Animal Welfare: Studies to be done as per IAEC (CPCSEA) approved Protocols (1).
Test System
Species: Rat
Strain: Wistar
Sex, Age: Female, 6-8 weeks
Procedure
In anesthetized animals 1-cm-long skin incision to be made over the third trochanter. The rectus femoris muscle will be gently incised to expose the shaft of femur. A 23-gauge needle will be drilled vertically in the shaft of femur at the third trochanter level, allowing it to reach the intramedullary canal of the femur. 10 μl volume of Walker 256 cells (105 cells) or Hank's solution (sham group) will be injected. After slow injectiondrill hole will be sealed using bone wax. The muscle and skin will be stitched and disinfected.Treatment start: 3 days post surgery.
Treatment end: 21 days.
Efficacy Readout:
• Body weights
• mechanical allodynia
• Behavioral tests
• Observations: General clinical signs
Analysis: One way ANOVA (95 % confidence level)
Group Treatment No. of animals / group
1 Normal control 10
2 Disease Control 10
3 Reference Control 10
4 IIIM Reference Control-1*# 10
5 IIIM Reference Control-2*# 10
6 Test Dose -1# 10
7 Test Dose-2# 10
8 Test Dose -3# 10
*IIIM Reference Control 1 and 2 will be provided by CSIR-IIIM along with test compound
Note:
*#Test and IIIM reference controls are controlled substances (under NDPS Act), the firm shall intimate and take necessary approvals to the concern state/Central authorities regarding storage, transportation and testing.
10
-
-
PRECLINICALSTUDY PACKAGE-II
-
-
-
Product- I- Efficacy of Test compounds in Cisplatin-induced Pain in Rat
Animal Welfare: Studies to be done as per IAEC (CPCSEA) approved Protocols (1).
Test System
Species: Rat
Strain: Sprague-Dawley
Sex, Age: Male/Female, 5-7 weeks
Procedure
Animals will be dosed with ten intraperitoneal injections of cisplatin every three days. The dose of cisplatin will be 2 mg/kg alternately with 1 mg/kg resulting in a cumulative dose of 15 mg/kg. Before each injection, 2 ml of saline will be injected subcutaneously to avoid cisplatin nephrotoxicity. The Normal control group will be injected saline.
Treatment start: from 1st day or 12th day onwards cisplatin injection.
Treatment end: 21 days.
Efficacy Readout:
• Body weights
• mechanical allodynia
• Thermal allodynia
• Clinical Observations: General clinical signs
Analysis: One way ANOVA (95 % confidence level)
Group Treatment
1. Normal Control
2. Control
3. Reference Control
4. IIIM Reference Control-1*
5. IIIM Reference Control-2*
6. Test Dose-1
7. Test Dose-2
8. Test Dose-3 *IIIM Reference Control 1 and 2 will be provided by CSIR-IIIM along with test compound
10
-
-
PRECLINICALSTUDY PACKAGE-III
-
-
-
Product- II- Efficacy of Test compounds in Monoiodoacetate Model of Osteoarthritis Pain in Rat Animal Welfare: Studies to be done as per IAEC (CPCSEA) approved Protocols (1)- Test System Species: Rat Strain: Wistar Sex, Age: Male/Female, 6-8 weeks Procedure: Animals is to be anaesthetized and given single intra-articular injection of 1 mg of monosodium iodoacetate (MIA) through the infrapatellar ligament of the right knee. Sterile saline: used for injections in normal control animals Treatment start: 5/7 days post MIA injection. Treatment end: Animals to be terminated 28/56 day post MIA injection. Efficacy Readout: • Body weights • Mechanical hyperalgesia • Histopathology • Clinical Observations: General clinical signs Analysis: One way ANOVA (95 % confidence level)
Group Treatment No. of animals / group
1 Normal control 10
2 Control 10
3 Reference Control 10
4 Test Dose -1 10
5 Test Dose-2 10
6 Test Dose -3 10
10
-
-
PRECLINICALSTUDY PACKAGE-IV
-
-
-
Regulatory safety studies of Phytopharmaceutical leads (Product- I*) in Mice and Rat
The study to be done in following three phases: Report of each study should include all results, raw data, interpretations, observations, conclusions.
(a) Acute single dose oral toxicity of Phytopharmaceutical lead (Product- I*) in mice and rat by oral route as per Appendix III of Schedule Y (GLP study).
(b) 10-days dose-range finding (DRF) study (non-GLP study) of Phytopharmaceutical lead (Product- I* ) in rat to identify a dose-range for 28-days repeated dose toxicity study.
(c) 28-days repeated dose oral toxicity study of Phytopharmaceutical lead (Product- I*) in rat as per Appendix III of Schedule Y (GLP study) (d) 28-days repeated dose oral toxicity study of Phytopharmaceutical lead (Product- I*) in mice as per Appendix III of Schedule Y (GLP study) *Test lead is controlled substances under NDPS act, the firm shall intimate and take necessary approvals to the concern state/Central authorities regarding storage, transportation and testing.
1
-
2
PRECLINICALSTUDY PACKAGE-V
-
-
-
Regulatory safety studies of Phytopharmaceutical lead (Product- II) in Mice and Rat
The study to be done in following three phases:
Report of each study should include all results, raw data, interpretations, observations, conclusions.
(a) Acute single dose oral toxicity of Phytopharmaceutical lead(Product- II) in mice and rat by oral route as per Appendix III of Schedule Y (GLP study).
(b) 10-days dose-range finding (DRF) study (non-GLP study) of Phytopharmaceutical lead (Product- II) in rat to identify a dose-range for 28-days toxicity study.
(c) 90-days repeated doseoral toxicity study of Phytopharmaceutical lead (Product- II) in rat as per Appendix III of Schedule Y (GLP study)
(d) 90-days repeated dose oral toxicity study of Phytopharmaceutical lead (Product- II) in mice as per Appendix III of Schedule Y (GLP study)
1
-
4
Evaluation Notes How It Works ?
Potential Partner
Select Your Requirements