Bioavailability (BA) / Bioequivalence (BE) in Pharma

Description

Bioavailability (BA) is defined as the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action.

Bioavailability studies provide an estimate of the fraction of drug absorbed as well as drug distribution and elimination. Bioavailability studies are also used to develop a therapeutic dosage regimen.

Generic drug products are drug products containing the same active pharmaceutical drug ingredient (API) in the same dosage form as that marketed by the innovator (brand) company. A generic drug product is considered a therapeutic equivalent to the innovator (brand) drug product if it meets the regulatory requirements for therapeutic equivalence. In generic drug development, bioequivalence studies are used to determine bioequivalence.

Bioequivalence (BE) is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

Bioequivalent drug products are pharmaceutical equivalent or pharmaceutical alternative products that display comparable bioavailability to a reference drug product when studied under similar experimental conditions.

The test drug product (generic product) is considered bioequivalent to the reference drug product if the rate and extent of absorption of the test drug does not show a significant difference from the rate and extent of absorption of the reference drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions.

BIOAVAILABILITY & BIOEQUIVALENCE COURSE CONTENT

1 INTRODUCTION

2 INTRODUCTION TO BA/BE

2.1. Basic Definitions-1

2.1.1. Active Pharmaceutical Ingredient (API)

2.1.2. Finished Pharmaceutical Product (FPP)

2.2. Basic Definitions-2

2.2.1. Reference Listed Drug (RLD)

2.2.2. Generic (Multisource) Pharmaceutical Products

2.2.3. Generic Drug & Reference Listed Drug (RLD)

2.3. Basic Definitions-3

2.3.1. Pharmaceutical Alternatives

2.3.2. Pharmaceutical Equivalence

2.4. Basic Definitions-4

2.4.1. Pharmaceutical Bioequivalency (Therapeutic Equivalency)

2.5. Basic Definitions-5

2.5.1. Drug Diffusion & Biopharmaceutics Classification System (BCS)

3 BIOAVAILABILITY

3.1. Introduction to Bioavailability

3.2. Reasons for Bioavailability (BA)

4 BIOEQUIVALENCY

4.1. Introduction to Bioequivalency (BE)

4.2. Reasons for Bioequivalency (BE)

4.3. In-Vitro and In-Vivo Studies for Bioequivalency (BE)

5 ELEMENTS OF BA & BE

5.1. Elements of BA & BE - 1

5.1.1. Bioavailability (BA)

5.1.2. Bioequivalency (BE)

5.1.3. ADME

5.1.4. Pharmacokinetics (PK) & ADME

5.2. Elements of BA & BE - 2

5.2.1. Pharmacokinetics (PK) Parameters

5.2.2. Plasma Concentration & Time Curve

5.2.3. The Area Under the Concentration Time Curve (AUC)

5.2.4. The Maximum Plasma Concentration (Cmax)

5.2.5. The Time to Reach Cmax (Tmax)

5.2.6. Bioequivalency (BE) Criteria

6 BA & BE STUDIES

6.1. Bioequivalency (BE) Study

6.2. Bioequivalency (BE) Study Design

6.3. Cross-over Study Design

6.4. Parallel Study Design

6.5. Comparison of Cross-over Study Design and Parallel Study Design

6.6. Study Population (Subjects)

6.6.1. Study Population (Number of Subjects)

6.6.2. Study Population (Health Conditions of Subjects)

6.6.3. Study Population (Study with Patient Subjects)
6.7. Study Conditions

6.8. Sampling Times

7 BIOWAIVER

7.1. Biowaiver

7.2. General Biowaiver Criteria

7.3. Biowaiver Criteria-1

7.4. Biowaiver Criteria-2

7.5. Biowaiver Criteria-3

7.6. General Biowaiver Criteria for Other Dosage Forms

7.7. General Biowaiver Criteria for Orodispersable Tablets

7.8. General Biowaiver Criteria for Oral Solutions

7.9. General Biowaiver Criteria for Parenteral Solutions

7.10. General Biowaiver Criteria for Emultions

8 CONCLUSION

8.1.Conclusion

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