ITFG/IPAC Collaboration BA/BE Technical Team ITFG/IPAC TECHNICAL TEAM: BA/BE IN VITRO AND IN VIVO TESTS Presented by: Stephen Farr, PhD 26 April 2000 Rockville,

Slides:

Advertisements

Similar presentations

Ramana S. Uppoor, M.Pharm., Ph.D., R.Ph.

Advertisements

Parametric Tolerance Interval (PTI) Test for Delivered Dose Uniformity (DDU) for Orally Inhaled and Nasal Drug Products (OINDP) Michael Golden On behalf.

The NAAB Accreditation Review Conference - The Importance of Your Input William C. Miller, FAIA Michiel Bourdrez, AIA Does architectural education change.

Determine impurity level in relevant batches1

Kyiv, TRAINING WORKSHOP ON PHARMACEUTICAL QUALITY, GOOD MANUFACTURING PRACTICE & BIOEQUIVALENCE Introduction to the Discussion of Bioequivalence.

Dynamic Systems Development Method (DSDM)

1 A Bayesian Non-Inferiority Approach to Evaluation of Bridging Studies Chin-Fu Hsiao, Jen-Pei Liu Division of Biostatistics and Bioinformatics National.

Dale P. Conner, Pharm.D. Division of Bioequivalence OGD, CDER, FDA

COMPARABILITY PROTOCOLS ACPS March 12-13, 2003 Stephen K. Moore, Ph.D. Chemistry Team Leader CDER/Office of New Drug Chemistry Co-Chair, Comparability.

Hanoi, WORKSHOP ON PREQUALIFICATION OF ARV: BIOEQUIVALENCE Introduction to the Discussion of Bioequivalence Study Design and Conduct Presented.

Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / October |1 | Regulatory Requirement on Dossier of Medicinal.

PK and PD Studies for Systemic Exposure of Locally Acting Drugs Industry View Lester I. Harrison, PhD Division Scientist 3m Pharmaceuticals.

Individual Bioequivalence Lawrence J. Lesko, Ph.D. Director Office of Clinical Pharmacology and Biopharmaceutics Advisory Committee for Pharmaceutical.

Interchangeability and study design Drs. Jan Welink Training workshop: Training of BE assessors, Kiev, October 2009.

1 ACPS November 15, Update Nancy B. Sager, Associate Director Office of Pharmaceutical Science Center for Drug Evaluation & Research Food and.

FDA Nasal BA/BE Guidance Overview

Physical Pharmacy Objectives

Venkata Ramana S. Uppoor, M.Pharm., Ph.D., R.Ph.

Codex Guidelines for the Application of HACCP

Tanzania, August, 2006 Dr. Barbara Sterzik, BfArM, Bonn 1 Guidelines and Tools available TRS 937 and BTIF (Bioequivalence Trial Information Form)

Bioequivalence of Topical Drug Products

Utility Requirement in Japan Makoto Ono, Ph.D. Anderson, Mori & Tomotsune Website:

Guidance for Industry M4S: The CTD-Safety

ITFG/IPAC Collaboration OVERVIEW OF ITFG/IPAC COLLABORATION Presented by: Harris Cummings, PhD 26 April 2000 Rockville, MD.

ITFG/IPAC Collaboration CMC Specifications Technical Team ITFG/IPAC TECHNICAL TEAM: CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 26 April 2000 Rockville,

CB-1 PULMINIQ™ (cyclosporine, USP) Inhalation Solution Benefit-Risk/Conclusions Stephen Dilly, MD, PhD Chief Medical Officer Chiron | BioPharmaceuticals.

Establishing Drug release/Dissolution Specifications – QBD Approach Moheb M. Nasr, Ph.D. Office of New Drug Quality Assessment (ONDQA), OPS, CDER Advisory.

Bioequivalence and Bioavailability Working Group.

1 The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays: History, Recommendations and Local Delivery Issues Wallace P. Adams, Ph.D. OPS/CDER/FDA.

Product Documentation Chapter 5. Required Medical Device Documentation  Business proposal  Product specification  Design specification  Software.

QUALITY OF EVIDENCE FRCC Compliance Workshop September/October 2008.

Executive Session Director’s CD-3b Review of the MicroBooNE Project January 18, 2012 Dean Hoffer.

Bioequivalence Studies and Other Recommendations for Orally Inhaled and Nasal Drug Products: Work of the ITFG/IPAC-RS Collaboration Presented by Cynthia.

1 Validation of non-formal and informal learning in Europe The challenging move from policy to practise Jens Bjornavold Rotterdam, 10 April 2014.

1 ORALLY INHALED AND NASAL DRUG PRODUCTS FOR LOCAL ACTION Current FDA BA/BE Background and Issues Wallace P. Adams, Ph.D. OPS/CDER/FDA OINDP Subcommittee.

WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, October, 2010 Regulatory principles reflected in practice of WHO PQP Milan Smid,

FAO/WHO Codex Training Package Module 4.3 FAO/WHO CODEX TRAINING PACKAGE SECTION FOUR – SCIENTIFIC BASIS FOR CODEX WORK 4.3 What is JECFA?

Ivowen Ltd1 Ivowen Limited Preparation and Submission of a Traditional Herbal Medicinal Product Application.

COMPARABILITY PROTOCOLUPDATE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE Manufacturing Subcommittee July 20-21, 2004 Stephen Moore, Ph.D. Chemistry Team.

Bioequivalence of Locally Acting Gastrointestinal Drugs: An Overview

The Conceptual Framework: What It Is and How It Works Linda Bradley, James Madison University Monica Minor, NCATE April 2008.

CLINICAL EFFICACY TESTING for NASAL DRUGS Mary M. Fanning, M.D., Ph.D. Associate Director for Medical Affairs Office of Generic Drugs, FDA June 4, 1999.

WHO Prequalification Programme June 2007 Training Workshop on Dissolution, Pharmaceutical Product Interchangeability and Biopharmaceutical Classification.

Guidance Update: Average, Population, and Individual Approaches to Establishing Bioequivalence Mei-Ling Chen, Ph.D. Associate Director Office of Pharmaceutical.

1 Subcommittee Report: Orally Inhaled and Nasal Drug Products (OINDP) Wallace P. Adams, Ph.D. OPS/CDER/FDA Advisory Committee for Pharmaceutical Science.

International Atomic Energy Agency Regulatory Review of Safety Cases for Radioactive Waste Disposal Facilities David G Bennett 7 April 2014.

ITFG/IPAC Collaboration Introduction OVERVIEW OF ITFG/IPAC COLLABORATION Presented by: Harris Cummings, PhD 26 April 2000 Rockville, MD.

ITFG/IPAC Collaboration CMC Supplier Quality Control Technical Team ITFG/IPAC TECHNICAL TEAM: SUPPLIER QUALITY CONTROL (QUALIFICATION) Presented by: Gordon.

Bioequivalence Criteria Research Plan Stella G. Machado, Ph.D. Office of Biostatistics and the Replicate Design Technical Committee Advisory Committee.

Lawrence X. Yu, Ph.D. Director for Science Office of Generic Drugs, OPS, CDER, FDA ACPS Meeting, ACPS Meeting, Oct. 22, 2003 Office of Generic Drugs Research.

Interchangeability and study design Drs. Jan Welink Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009.

Orally Inhaled and Nasal Drug Products Subcommittee Introduction and Objectives Eric B. Sheinin Deputy Director Office of Pharmaceutical Science Center.

FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008 Introduction and Update Helen N. Winkle Director, Office of.

Food and Drug Administration Division of Pulmonary and Allergy Drug Products Summary Comments - Orally Inhaled and Intranasal Budesonide and Fluticasone.

CDER / FDA1 Clinical Study Options for locally acting nasal suspension products Robert J. Meyer, MD Director, Div. Of Pulmonary and Allergy Drug Products.

Orally Inhaled and Nasal Drug Products (OINDP) Subcommittee Report to the Advisory Committee for Pharmaceutical Sciences Rockville, Maryland November 15,

Joint Non-Prescription Drugs and Pediatric Advisory Committee Meeting October 18-19, 2007 Considerations for Extrapolation of Efficacy from Adults to Children.

ITFG/IPAC Collaboration CMC Leachables and Extractables Technical Team ITFG/IPAC TECHNICAL TEAM: CMC LEACHABLES AND EXTRACTABLES Presented by: Kaushik.

Session 7: VICH Conference

The First Conference for Medicines Regulatory Authorities In Sudan and Neighboring Countries Khartoum December 2014 Alain PRAT, Technical Officer,

Conclusion Senior Vice President Medical & Drug Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut Manfred Haehl, MD.

Pre-Investigational New Drug (pre-IND) Meeting with FDA

Report Writing Three phases of report writing Exploratory phase (MAPS)

Flooding Walkdown Guidance

Regulatory Perspective

NUR 598 Enthusiastic Studysnaptutorial.com

PEM PAL IA COP AiP Working Group Guidance to Audit Engagement Planning

Michael Gross, Ph.D., RAC Vice-President Worldwide Compliance

Rules of Evidence  The State of Queensland (Department of Education and Training),

Draft Mandate to request SCHER opinion on the TGD-EQS

Presentation transcript:

ITFG/IPAC Collaboration BA/BE Technical Team ITFG/IPAC TECHNICAL TEAM: BA/BE IN VITRO AND IN VIVO TESTS Presented by: Stephen Farr, PhD 26 April 2000 Rockville, MD

ITFG/IPAC Collaboration BA/BE Technical Team BA/BE: IN VITRO TESTS BA/BE: IN VIVO TESTS 11 Apr 00 Working Proposition In vitro testing is essential for pharmaceutical product equivalence and should be included as part of BA/BE Guidance for all nasal and oral inhalation products, but is not currently sufficient for BE approval without establishing in vivo BE. 11 Apr 00 Working Proposition For BE approval, BA/BE Guidance documents for nasal and oral inhalation drug products for local action should require use of validated human models for in vivo testing for local and systemic exposure, efficacy and safety. WORKING PROPOSITIONS

ITFG/IPAC Collaboration BA/BE Technical Team WORKING ASSUMPTIONS The Team’s BA/BE recommendations apply to locally acting drugs only (per the current draft BA/BE Guidance). The Team’s comments apply to both orally inhaled and nasal drug products, but the dosage forms should be treated in separate Guidances. Scientific and clinical bases for developing BA/BE Guidance are evolving. The Team’s BA/BE working propositions reflect only the current state of knowledge.

ITFG/IPAC Collaboration BA/BE Technical Team CONCLUSIONS TO DATE Based on the available literature, current in vitro tests may predict lung deposition but BE predictability has not been shown In vitro tests described in current draft BA/BE Guidance are not necessarily more relevant or discriminating than clinical studies for BE assessment Systemic PK/PD estimates systemic exposure (i.e., safety) but does not estimate local delivery (i.e., efficacy and local tolerance). Efficacy assessments alone cannot establish in vivo BE since they will not assure comparable safety (systemic exposure). Because all of the preceding statements apply equally to solutions and suspensions, the assumption that in vitro studies alone are sufficient for BE of solutions is unfounded. The Guidance should not distinguish between nasal suspensions and solutions for in vivo BE.

ITFG/IPAC Collaboration BA/BE Technical Team BA/BE TEAM’S COMMITMENTS Team is committed to prepare a technical paper on the BA/BE issues in the draft BA/BE Guidance. The purpose of the paper will be to: Highlight areas where there is sufficient data to draw conclusions and where there is not enough data at present Review technical documentation related to BA/BE issues addressed by the Team Team expects to complete the paper by end of June 2000