m pharmacy notes nik salunkhe notes

2. A SEMINAR ON
ANDA REGULATORY APPROVAL PROCESS
By
Salunkhe Nikhil Jayvantrao
Under The Guidance Of
Mrs. A.K. Salunkhe
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3. DEFINITION OF A ANDA
 An “Abbreviated New Drug Application” (ANDA) is an application
for a generic drug approval for an existing approved drug.
 termed as "abbreviated" because they generally not required to include
preclinical (animal) and clinical (human) data to establish safety and
effectiveness
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4. ANDA
CONTENTS
1. Section 1: Overall ANDAindex
2. Section 2: Labeling
3. Section 3: Application summary
4. Section 4: Chemistry, manufacturing and controls
5. Section 5: Nonclinical pharmacology and toxicology
6. Section 6: Human Pharmacokinetics and bioavailability
7. Section 7: Microbiology
8. Section 8: Safety data
9. Section 9: Statistical data
10. Section 10: Case report tabulation
11. Section 11: Case report forms
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5. 1.OVERALL ANDA
INDEX-
The index is a extensive table of contents that enables the
reviewers to find specific information in this big document
quickly.
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6. 2.LABELING:
•“Same” information as brand name labeling
•May delete portions of labeling protected by patent (i.e., an indication, strength)
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7. 3.APPLICATION SUMMARY-
•Nonclinical pharmacology and toxicology summary
•Clinical data summary
•Human pharmacokinetics and bioavailability summary
•Benefit and risk
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8. 4.CHEMISTRY, MANUFACTURING AND
CONTROLS (CMC):
• Components and composition
• Batch formulation and records
• Specifications and testing
• Packaging
• Stability
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9. 5.NONCLINICAL PHARMACOLOGY AND TOXICOLOGY-
•Provide individual study reports, including pharmacology, toxicology,
ADME studies.
•Interactions with other drugs
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10. 6.HUMAN PHARMACOKINETICS AND
BIOAVAILABILITY
• data from Phase I safety and tolerance studies in healthy volunteers
• Summary of analytical method used
• Bioavailibility or bioequivalence studies
• Pharmacokinetic studies
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11. 7.MICROBIOLOGY:-
•A complete description of the biochemical basis of the drug action on microbial
physiology
•The drugs antimicrobial spectrum
•Describe any known mechanism of resistance to the drug.
Assure the sterility of the product through the manufacturing process – especially
important with injectable drug products.
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12. 8.SAFETY DATA -
• Contra indications
• Warnings
• Precautions
• Adverse events
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13. 9.STATISTICAL DATA-
•All controlled clinical trial reports
•Complete efficacy and safety summaries
•Complete summary of risks and benefits
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14. 10.INSPECTIONS/TESTING:-
•Assure manufacturing facilities are fulfill with current good manufacturing
practices (cGMPs)
•Assure bioequivalence sites are fulfill with current good clinical practices
(cGCPs)
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15. 11.BIOEQUIVALENCE:-
A generic drug is considered to be bioequivalent to the
brand name drug if:
•The rate and extent of absorption do not show a significant
difference from listed drug
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16. BIOEQUIVALENCE -
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17. APPROVALOF ANDA:-
• FDA will approve an application and issue the applicant an approval
letter on the basis of draft labeling
• if the only deficiencies in the application concern editorial or similar
minor deficiencies in the draft labeling.
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