Aizant Drug Research Solutions provides integrated drug development solutions including contract development organization (CDO) and contract research organization (CRO) capabilities. The presentation outlines Aizant's business verticals, infrastructure, services, certifications, management team, experience, expansion plans, and advantages. It also provides contact information for Aizant.
A Brief presentation on the Code of Federal Regulations in Pharmaceuticals (21 CFR), which covers the following aspects:
- Introduction to CFR
- Organization and structure of CFR
- History of CFR
- Table of Contents
- Title 21; CFR in Pharmaceuticals
- IND Application process regulations
- Research tools in CFR
A Brief presentation on the Code of Federal Regulations in Pharmaceuticals (21 CFR), which covers the following aspects:
- Introduction to CFR
- Organization and structure of CFR
- History of CFR
- Table of Contents
- Title 21; CFR in Pharmaceuticals
- IND Application process regulations
- Research tools in CFR
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
What is ICH Q8 guidelines?
Image result for ICH Pharmaceutical development guideline-Q8
The ICH Q8 guideline is intended to provide guidance on the contents of Section 3.2. P. 2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4).
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
In this slide contains Investigation, reason, case study of OOS.
Presented by: K Venkatsai Preasad. (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Visit:www.acriindia.com
ACRI is a leading Clinical data management training Institute in Bangalore India.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
Database Designing in Clinical Data ManagementClinosolIndia
When designing a Clinical Data Management (CDM) database, several key considerations should be taken into account to ensure efficient data capture, storage, and retrieval. Here are some important aspects to consider in CDM database design:
Define Study Requirements:
Understand the specific requirements of the study and the data to be collected. This includes variables, data types, formats, and any specific rules or calculations required for data validation and derivation. Consult with the study team and stakeholders to determine the necessary data elements.
Data Model Design:
Develop a data model that represents the structure and relationships of the data. Use standard data models, such as CDISC (Clinical Data Interchange Standards Consortium) standards, as a foundation. Define entities (e.g., patients, visits, assessments) and attributes (e.g., demographics, lab results) and establish relationships between them.
Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
What is ICH Q8 guidelines?
Image result for ICH Pharmaceutical development guideline-Q8
The ICH Q8 guideline is intended to provide guidance on the contents of Section 3.2. P. 2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4).
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
In this slide contains Investigation, reason, case study of OOS.
Presented by: K Venkatsai Preasad. (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Visit:www.acriindia.com
ACRI is a leading Clinical data management training Institute in Bangalore India.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
Database Designing in Clinical Data ManagementClinosolIndia
When designing a Clinical Data Management (CDM) database, several key considerations should be taken into account to ensure efficient data capture, storage, and retrieval. Here are some important aspects to consider in CDM database design:
Define Study Requirements:
Understand the specific requirements of the study and the data to be collected. This includes variables, data types, formats, and any specific rules or calculations required for data validation and derivation. Consult with the study team and stakeholders to determine the necessary data elements.
Data Model Design:
Develop a data model that represents the structure and relationships of the data. Use standard data models, such as CDISC (Clinical Data Interchange Standards Consortium) standards, as a foundation. Define entities (e.g., patients, visits, assessments) and attributes (e.g., demographics, lab results) and establish relationships between them.
Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
Over the past few decades, medical science and its multiple domains have taken a quantum leap with the help of the latest technologies. The same applies for biometrics, that can be defined as a technology that helps in identification of individuals based on their physical and behavioral traits.
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
Blueprints to blue sky – analyzing the challenges and solutions for IHC compa...Candy Smellie
Manual assessment of biomarker expression is associated with significant inter- and intra reader variability. In some cases there are also limitations when it comes to sensitivity and specificity of manual biomarker assessment.
In one example to the left, the “pure” contribution of inter-reader variability associated with Ki67 assessment was quantified across 20 tumors and 126 participating labs. In that study, it was demonstrated how image analysis can be used to significantly reduce inter-reader variability.
In a another study, the National Danish Validation study of Her2, it was demonstrated how improved sensitivity/specificity of quantitative HER2 protein expression wrt gene amplification lead to significant cost savings in reflex testing.
By automating aspects of stain quality control, it will become scalable to he point where EQA organizations may be able and willing to offer more frequent – perhaps even on-demand – proficiency testing and calibration services.
It is possible that objective and quantitative standards will contribute to improve compliance with protocol recommendations.
In clinical multi-center trials it will be easier to standardize and monitor data from each center.
And it is our hope tha larger diagnostic pathology labs will be able to benefit from such a method by closely monitoring drift in staining quality for biomarkers.
Strand SmartLab - Enabling Precision Medicine at community HospitalsHarsha Rajasimha
Strand SmartLab is a complete soup to nuts solution that enables a community hospital to establish precision medicine testing services in-house. This enables the retention of revenues internally rather than loosing them to external third party laboratories. Genomics driven precision medicine for Cancer and other diseases require highly skilled people, lab equipment, processes, regulatory experts, bigdata software, databases and curation, medical geneticists to interpret the results in clinical settings and genetic counselors. Strand SmartLab brings all these to your institution in a pre-packaged solution.
1. Aizant Drug Research Solutions
Integrated Drug Development Solutions
7/3/2012 Confidential 1
2. Flow of presentation
• Introduction
• Business verticals
– CDO Capabilities
– CRO Capabilities
• Support functions
• Advantage
• Contacts
7/3/2012 Confidential 2
3. Milestones
7/3/2012 3Confidential
2005 • Aizant incorporated
2008 • Formulation R&D and clinical operations started
2009 • cGMP facility commissioned
Aug
2009
• R&D centre recognized by Dept. of Science and Industrial Research, GoI
Apr
2010
• Clinical facility audited by US FDA with NO 483s
May
2010
• Diagnostics laboratory accredited by NABL
Aug
2010
• Clinical facility was approved by Brazilian ANVISA
Oct
2011
• Clinical facility approved by WHO
Dec
2011
• Clinical facility approved by Turkey MoH
4. Vision & Mission
7/3/2012 Confidential 4
• To be a global leader for science based integrated drug
developmentsolutionsVISION
• Pursuit of excellence through science and technology
• Agile team with open communication and honoring
deliverables
• Environmentally and socially responsible research
MISSION
• Innovation
• People
• Learning
• Quality
VALUES
5. Quality
• Quality is by design and not an after thought
• QbD is fundamental to our operations
– Targetthe product profile (TPP)
– Determine the critical quality attributes (CQAs)
– Link input material attributes and process parameters to CQAs and perform
risk assessment
– Develop a design space
– Designand implement a control strategy
– Manageproduct lifecycle, including continual improvement
7/3/2012 Confidential 5
6. Flow of presentation
• Introduction
• Business verticals
– CDO Capabilities
– CRO Capabilities
• Support functions
• Advantage
• Contacts
7/3/2012 Confidential 6
7. Business Verticals
7/3/2012 Confidential 7
CDO
Contract
development
NCEs and LCMs
Specialtyproducts
Preclinicaltox
formulations
Enablingformulations
First in human
formulations
Late stage clinical
formulations
Generics etc.
cGMP
Manufacturing
Clinical trial
material
Commercial
manufacturing of
low volume
products
CRO
Clinical studies
BA/BE studies
Bioanalytical
Patient studies
(Oncology)
ExpansionPlans:
PhaseI to III clinical
trials & data
management
8. CDO – Infrastructure
• State of the art pharmaceutical development laboratories spread over 40,000
sqfeet
• Modern equipments and instruments in formulation and analytical
laboratories in tune with latest technology
• ~ 80,000 sq ft open space for scaling up any operations within short time
• Developmentcapabilities for:
– Oral dosage forms (solid/ liquid)
– Novel Drug Delivery Systems
• Controlledrelease/ sustainedrelease/ extended/ modified release dosage forms
• Multiparticulate systems
• Gastro-retentive system
– Topical dosage forms
– Parenteraldosageforms
– Ophthalmicdosage forms
7/3/2012 Confidential 8
9. CDO - Services
7/3/2012 Confidential 9
Preformulation
• Reverse
engineering
• Thermal analysis
• Dynamic vapor
sorption
• Particlesize
analyser
• Viscosity
measurements
• Solubility studies
• Dissolution
studies
• XRPD, SEM, Hot
stage
microscopy*
Formulation
Development
• Dry blending
• High shear
granulation
• Fluid bed
granulation
• Roller compaction
• Extrusion
spheronisation
• Wurstercoating
• Spraydrying
• Micronization
• PanCoating
• Encapsulation
Analytical
Development
• Method
development
• Method
validation
• Method
qualification
• Methodtransfers
• Stabilitystudies
• Chiral analysis
• Microscopy
Other Services
• Scale-upand
technology
transfer
• Standalone
stabilitystudies
• Product
registrationand
regulatory
support
• Clinical support
• Upcomingfacility
forpotent
substances
10. cGMP – Infrastructure
• About 10,000 sq. feet cGMP area for scale up and clinical batch
manufacturing
• Designed to meet US FDA/ MHRA standards
• DedicatedAHUs
• Flexibility of manufacturing batches from 0.05kg to 80kgs
• Power back to ensure smooth operations
• EnsuresOSHA compliance and other industry legislations
• Process train for solid orals:
– Up to 15 kg
– Up to 100 kg
7/3/2012 Confidential 10
11. cGMP - Services
7/3/2012 Confidential 11
Scale up
• Scaleup of
formulation
development
products
• Manufacturing
batchesfor
regulatory
submissions
• Commercial
manufactureof
low volume
products
• Allkinds of
packaging
Clinical trial
material
• Investigational
drug product
• Placebo
• Encapsulationof
tablets,
multiparticulate,
capsulesand
other solid
dosage forms
• Comparator
manufacturing
• Clinical
packaging,
blinding,
randomization
Analytics
• Testingand
release of
finishedgoods
• Cleaning
validation/
process
validation
• Microbiology
• Standalone
stabilitytesting
Other Services
• Regulatory
support
15. CRO – Infrastructure
• 80 bed (2 clinics) facility spread over 28,000 sq feet
• IP based cameras to virtually monitor projects
• Dedicated registration area
• Independent ethics committee
• In-house NABL accredited clinical diagnostics laboratory
• In-house kitchen
• Bioanalytical laboratories equipped with 7 LCMS/MS including API 5500
• Offsite storage of data for disaster recovery and business continuity
• Volunteer database
• Male: 4000+
• Female: 600+
• Access to post menopausal women database
7/3/2012 Confidential 15
16. CRO - Services
7/3/2012 Confidential 16
Clinical
Pharmacology
• Clinical studies for
males, females
and special
population
• BA/BE studies for
global submissions
• Proof of concept
studies
Bioanalytics
• Method
development and
validation
• Method transfer
of drugs in
biological matrix
• LCMS-MS and
HPLC analysis of
drugs and
metabolites in
biological matrix
from clinical trial
PK
&Biostatistics
• Study design
• CRF review
• Randomization
schedule
• Statistical analysis
& reporting (SAS
9.2 and WinNonlin
5.2 software)
• Well trained staff
Diagnostics
•Hematology
•Biochemistry
•Immunology
•Urine analysis
•X-ray
17. CRO - Regulatory approvals
• US FDA audited facility with NO 483s
• ANVISA inspection successfullycompleted (No major or critical
observations)
• NABL accreditation for clinical diagnostics
• DCGI inspected and approved
• WHO approved
• Turkey MoH approved
• Working on EMEA inspection
7/3/2012 Confidential 17
20. Flow of presentation
• Introduction
• Business verticals
– CDO Capabilities
– CRO Capabilities
• Support functions
• Advantage
• Contacts
7/3/2012 Confidential 20
21. Project management
• Cross functional project teams from formulation, analytical,
quality and regulatory departments
• All projects teams are monitored on MS projects by an
experienced project manager
• Metrics based project planning and execution
• Well defined communicationsystems as decided at beginning of
project
• Good track record of completing projects on time
7/3/2012 Confidential 21
22. Informationtechnology
• Data-centrewith backup and recovery facility
• Offsitedata storage for disaster recovery
• IP Cameras for remote virtual monitoring of projects
• Biometrics for cross-check and validation
• Well defined IT policy for security and access control
• Metrics based reporting
7/3/2012 Confidential 22
23. Key Management Team & Scientists
7/3/2012 Confidential 23
S.No. Name Designation Qualification Years of
experience
Patents and
publications
Area of specialization
1 Varma Rudraraju Chairman and
Managing Director
MS (Pharmaceutics), University
of Mississippi, USA
Ph.D. (Pharmaceutics),
University of Mississippi, USA
20 21
publications
Preformulation to
commercial
manufacturing including
clinical
Business strategy
2 Ashok Illpakurthy DirectorProduct
Development
MS (Pharmaceutics), University
of Mississippi, USA
Ph.D. (Pharmaceutics),
University of Mississippi, USA
14 7 publications Formulation
development
QbD, DoE
Certified “Chemical
Design for Six Sigma”
(CDFSS) black belt
3 Narasimhan K Associate Director
Analytical
Development
MS (Physical Chemistry),
Bombay University, Mumbai
MS (Analytical Chemistry), SIU,
Carbondale, IL, USA
Ph.D., (Analytical Chemistry),
Purdue University, IN, USA
11 17
Publications;
Oral
presentations
Analytical development
and validations;
Bioanalytical;
Solid state chemistry
Process development;
QbD, DoE;
Stability studies
Totalteam of 300 + people between Product development,clinical
developmentandGMP business verticals
24. Key Management Team & Scientists
7/3/2012 Confidential 24
S.No. Name Designation Qualification Years of
experience
Patents and
publications
Area of specialization
4 Tathagata Dutta Deputy Director-
Formulation
Development
M. Pharm, Dr. Hari Singh Gour
University, Sagar;
Ph.D., Dr. Hari Singh Gour
University, Sagar;
Post Doc., University of
Queensland, Brisbane, Australia
8 23
Publications;
2 Book
Chapters,
Invited
Lectures and
Oral
Presentations
in International
Conferences
Formulation
Development;
Novel Drug Delivery
Systems;
Dendrimers;
Nanotechnology;
Drug and Gene Delivery;
Development of RNAi
therapeutics
5 Suneela Prodduturi Associate Director,
Formulation
Development
Ph.D., Pharmaceutics, Post
Doctoral fellowship in Drug
Delivery
11 14 publications
and 25
presentations
(International)
Solubility enhancement
using solid dispersions
and melt extrusion
technology; Transdermal
and Transmucosal Drug
Delivery
6 Karan Singh Deputy Director
Analytical
Development
M.Sc (Chemistry) from
Rohilkhand University, Bareilly
(UP) India.
Ph.D. (Chemistry) from
Rohilkhand University, Bareilly
(UP) India
15 5 Publications Method Development,
Validation & Stability
studies of all kind of
Finished dosage forms.
25. Key Management Team & Scientists
7/3/2012 Confidential 25
S.No. Name Designation Qualification Years of
experience
Patents and
publications
Area of specialization
7 Rajan Kombu
Subramanian
Senior Manger,
Bioanalytical
Department
M.Pharm, Gujrat University;
Ph.D., Kakatiya University;
MS, Case Western Reserve
University, USA
9 Patent-1;
Publications-
21;
Book Chapters-
1
Bioanalytical method
development and
validation using GC-MS
and LC-MS/MS
8 Ramesh Mattupalli DirectorQuality
Assurance
M.Pharm, (Pharmacognosy)
Banglore University
12 None Quality assurance
9 Anand Bhogu Vice President-
Clinical
Development
MSc (Biotech),
MPhil (National Chemical
Laboratory, CSIR, Pune, India)
14 None Project Management BA
BE studies (healthy and
patient based PK studies),
Discovery, Phase I, Phase
II- III,
Business Development
26. Flow of presentation
• Introduction
• Business verticals
– CDO Capabilities
– CRO Capabilities
• Support functions
• Advantage
• Contacts
7/3/2012 Confidential 26
27. Experience
7/3/2012 Confidential 27
Projects
Handled over 150
developmentand
200 + clinical
projects since
inception
development
projects include:
Simple IR , complex IR,
Simple MR, complex MR,
Combination products,
LCMs, NCEs
Geography
Rich experience of
working in various
regulatory
environment
USA, EU, LatAm,
Worldwide, RoW
Clients
Versatileinworking
with various
partners
Big Pharma,
Specialty,
Generics, Indian
Generics
28. ExpansionPlans
• Adding potent development suite (completedevelopment under
isolators) for handling highly potent molecules
• Adding another 40 bed clinic for handing BA/BE studies
7/3/2012 Confidential 28