HELLO I AM PRABHAT DEWANGAN HERE I ATTECHED MY PRESENTATION OF OUT SOURCING BA AND BE TO CRO. UNIT 1 PART A M.PHARM 1ST SEMESTER

1. OUTSOURCING BA AND BE TO CRO.
DEPARTMENT OF PHARMACY
GURUGHASIDAS VISHWAVIDYALAY
SUBMITTED BY
PRABHAT DEWANGAN
M.PHARMA
GUIDED BY
DR. S.K. LANJHANIYA
(Assistant Professor)

2. OUTSOURCING
Out sourcing is the business practice of hiring a party outside a company to perform
services and create goods that traditionally were performed in-house by company’s own
employes and staff.
Outsourcing is generally done to reduce the costs and improving the efficient resources
within a company.
Example – of outsourcing is bioavailability, bioequivalence, r and d department.

3. BIOAVAILABILITY –
It is defined as rate and amount of absorption of unchanged drug from its dosage form.
• ABSOLUTE BIOAVAILABILITY – Systemic availability of drug administered orally which is
determined in comparison to its I.V. administration.
• RELATIVE BIOAVAILABILITY – Systemic availability of drug after oral administration is
compared with the oral standard of same drug.

4. BIOEQUIVALENCE –
It refers that the drug substance in two or more identical dosage form, reaches the
systemic circulation at the same rate and at same extent i.e. their plasma concentration
Time profiles will be identical without significant statistical differences.
Types of equivalence –
1. Chemical equivalence
2. Pharmaceutical equivalence
3. Therapeutic equivalence

5. CHEMICAL EQUIVALENCE – two or more drug products contains the same labelled
chemical substances as an active ingredient in same amount.
PHARMACEUTICAL EQUIVALENCE – two or more drug products are same in strength,
quality, purity, content uniformity, disintegration and dissolution characteristics.
THERAPEUTIC EQUIVALENCE – this term indicates that two or more drug product contains
same therapeutically active ingredients elicit identical. pharmacological effects and can
control the disease to same extent.

6. CRO (CONTRACT RESEARCH ORGANIZATION )
CRO is an organization that provide support to the pharmaceutical, biotechnology and
medical devices industry in the form of research services out sourced on a contract basis.
It offers various pharmaceutical research that is essential for conducting clinical trials the
ICH technical requirements for registration of pharmaceutical for human use.

7. REASONS OF OUTSOURCING
Many of the larger pharmaceutical companies have in-house capabilities for most, if not
all, of these services. For example many often have there own clinical and bioanalytical
unit that provide full support for phase 1 studies. However, even these intern resources
can become saturated due to the drive to develop more compound in shorter time
interval.
Unlike their larger counter parts, the smaller companies, virtual firms and generic
companies do not have the luxury of their own dedicated clinical unit or full in-house
capabilities and are required to outsource their clinical trials, including bioavailability and
bioequivalence studies.

8. Although generic companies have internal resources for product development,
manufacturing and release testing, they do not have clinical and bioanalytical
capabilities.
KEY ELEMENTS NECESSARY FOR SUCCESS INCLUDE THE FOLLOWING :
Communication at all levels between the CRO and the pharmaceutical company.
Sensitivity to both the project specific requirements and timelines.
Flexibility to recognize and adjust to unexpected events throughout the project timeline.

9. IDENTIFICATION OF APPROPRIATE CROs
It is important that your CRO has validate corporate procedures for all segments of clinical
study conduct. These procedures are used to ensure that all aspects of a study, including
but not limited to clinical conduct, laboratory analysis, data management, biostatistics,
pharmacokinetics, and medical writing, are performed in compliance with good clinical
practices (GCP), good laboratory practices (GLP), and other applicable regulatory practices
and guidelines.

10. ASSESSMENT OF CAPABILITIES
1. Clinical capabilities
2. Bioanalytical capabilities
3. Pharmacokinetic capabilities
4. Timeline assessment
CLINICAL CAPABILITIES
The first step to CRO qualification is the assessment of their capabilities and experience.
The ability of a CRO to recruit a particular patient or volunteer population is a primary
requirements. The CRO should be able to recruit the entire study population at a single
centre, preferably as a single group. Healthy volunteer populations are the easiest to
recruit; however, some studies may require large numbers of subjects or replicate designs.

11. For example, oestrogens are generally dosed to postmenopausal females. Other drugs may
be targeted to an elderly population. It is essential that the CRO be assessed for its ability
to recruit these special population.
BIOANALYTICAL CAPABILITIES
Just as the clinical capabilities must be assessed, the bioanalytical Capabilities are equally
important. Validation lists are available from most CROs. It is critical that the bioanalytical
facility be experienced in analysing the drug and should be able to provide a written
validation report. The validation should be assessed before awarding the study or at least
before dosing. In addition to having an appropriately validated method, the facility should
follow current GLPs and have a clean U. S. Food and drug administration inspection history.

12. PHARMACOKINETIC CAPABILITIES
Most companies focus primarily on the clinical and bioanalytical capabilities for CRO
selection. However, the pharmacokinetic capabilities should also be critical assessed.
The CRO should have validated pharmacokinetic and statistical programs in place and
should be compliant with 21 CFR part 11.
TIMELINE ASSESSMENT
The list of CROs that meet the company’s clinical, bioanalytical, and pharmacokinetic
criteria must be assessed for their ability to meet the company’s timeline. The CRO must
be able to meet the timelines as established by the company management team.

13. CRO QUALIFICATION
1. Due Diligence
2. Clinical Site Qualification
3. Bioanalytical Site Qualification
4. Pharmacokinetic Site Qualification
DUE DILIGENCE –
If the pharmaceutical firm has used the CRO in the past, they should objectively evaluate
their past experience with this CRO. If the experience was good, the firm should identify
those components that were successful and insure that they are used for their new study.
However, caution should be exercised and due diligence pursed if the new study requires
a different subject population or analytical technique. Ex- a CRO may specialize in
recruiting healthy male and female volunteers, but may have difficulty in the recruitment

14. of post Menopausal females.
CLINICAL SITE QUALIFICATION –
The sponsor should conduct a site qualification visit.
BIOANALYTICAL SITE QUALIFICATION
Candidate CROs for bioanalytical laboratory work should also be assessed. The company
audit should also include cGLP compliance and an assessment of the laboratory’s
inspection history. Copies of the inspection history with all FDA 483s and establishment
inspection reports should be reviewed. Laboratory project manager should be assessed
for their ability to coordinate. All processes with client, clinic and pharmacokinetic.
Finally, the CRO should provide written documentation as to the content of the final
analytical report that should contain additional project specific validation data to support
BA/BE study.

15. PHARMACOKINETIC SITE QUALIFICATION
The pharmaceutical firm should also qualify the CRO site that is responsible for
Pharmacokinetic and statistical analyses and completion of the final integrated report.
During the pharmacokinetic site audit, following areas should be assessed;
Qualification of pharmacokinetic and statistical personnel.
Validation of pharmacokinetic and statistical programs. Compliance with 21 CFR part 11. at
the time of this publication, full and complete compliance with part 11 was not being
enforced. However, the CRO should have a written plan and timeline for bringing all post
laboratory functions into compliance.

16. THANK
YOU