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Dermatopharmacokinetics (DPK). Dale P. Conner, Pharm.D. Division of Bioequivalence Office of Generic Drugs, CDER, FDA. Background. Bioequivalence (BE) Current BE Methods for Topical Products. Definition of Bioequivalence.

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dermatopharmacokinetics dpk

Dermatopharmacokinetics (DPK)

Dale P. Conner, Pharm.D.

Division of Bioequivalence

Office of Generic Drugs, CDER, FDA

background
Background
  • Bioequivalence (BE)
  • Current BE Methods for Topical Products
definition of bioequivalence
Definition of Bioequivalence
  • Pharmaceutical equivalents whose rate and extent of absorption are not statistically different when administered to patients or subjects at the same molar dose under similar experimental/clinical conditions
purpose of be
Purpose of BE
  • Therapeutic equivalence (TE)
  • Bioequivalent products can be substituted for each other without any adjustment in dose or other additional therapeutic monitoring.
  • The most efficient method of assuring TE is to assure that the formulations perform in an equivalent manner.
model of oral dosage form performance
Model of Oral Dosage Form Performance

Pharmacokinetic Measurement

Clinical/PD Measurement

Dosage Form Performance

Drug in

Solution

Gut Wall

Blood

Site of

Activity

Therapeutic

Effect

Dosage

Form

ln Dose

Dose

model of topical skin dosage form performance

ln Dose

Dose

Model of Topical (Skin) Dosage Form Performance

Clinical/PD Measurement

Pharmacokinetic Measurement

Dosage Form Performance

DPK

Drug

In Tissue

Site of

Activity

Therapeutic

Effects

Blood

Systemic

Effects

Dosage

Form

model of topical skin dosage form performance1

ln Dose

Dose

Model of Topical (Skin) Dosage Form Performance

Clinical/PD Measurement

Pharmacokinetic Measurement

Dosage Form Performance

DPK

Drug

In SC

Site of

Activity

Therapeutic

Effects

Blood

Systemic

Effects

Dosage

Form

Drug

In Follicles

Drug

In Other

current methods be methods for topical products
Current Methods BE Methods for Topical Products

BE Study with Clinical End-points

Expensive

Insensitive to differences in formulation performance

BE Study with Pharmacodynamic End-points

Limited to only a few classes of compounds (glucocorticoids)

In Vitro Drug Release

clinical pd dose response
Clinical/PD Dose-Response

Clinical/PD Response

Log Dose

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (www.fda.gov/cder/guidance/old098fn.pdf)

description of dpk method
Description of DPK Method
  • Theory
    • Pharmacokinetic approach applied to drug concentrations in stratum corneum (SC)
  • Method
    • Tape stripping is used to remove successive layers of SC after topical drug administration
    • Uptake and elimination from SC are determined
    • Differences in formulation performance (BE) are determined at the same time in the same individual
history
History
  • Workshops - AAPS/FDA
    • May 1989
    • March 1990
    • December 1991
  • FDA/Industry Conference: March 1992
  • Advisory Committee (GDAC) - BE/DPK: April 1992
  • Bio-International, Bad Homburg, Germany: May 1992
history1
History
  • Workshop - AAPS/FDA on SUPAC and DPK: May 1993
  • EUFEPS Nuremburg Conference: December 1995
  • Bio-International, Tokyo, Japan: April 1996
  • Workshop - AAPS/FDA on BE of Topicals: September 1996
  • Trade Association Meetings: April 1997 and December 1997
history2
History
  • Advisory Committee (ACPS) - BE/DPK: December 1997
  • Advisory Committee (DODAC) - BE/DPK: March 1998
  • Draft Guidance: June 18, 1998
  • Joint Advisory Committee (ACPS and DODAC): October 23, 1998
  • Expert Member and SGE meeting: July 30, 1999
history3
History
  • Expert Members and Representatives from ACPS and DODAC: October 23, 1999
  • Symposium - AAPS Annual Meeting: November 1, 2000
  • Joint Advisory Committee (ACPS and DODAC): November 17, 2000
issues
Issues
  • Is the DPK method an appropriate approach for establishing bioequivalence of topical drug products?
  • Are results and conclusions derived from the DPK method consistent within and between laboratories?
  • Can DPK methodology be established in any laboratory or CRO with a reasonable amount of time, effort and expense?