USP and Dissolution Testing

Slides:

Advertisements

Similar presentations

ICH Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) Overview and Update Robert H. King, Sr. Office of Pharmaceutical.

Advertisements

Statistical Evaluation of Dissolution for Specification Setting and Stability Studies Fasheng Li Associate Director, Pharmaceutical Statistics Worldwide.

USP and Dissolution Testing Advisory Committee for Pharmaceutical Sciences 2 May 2005 Will Brown Staff Liaison to the Biopharmaceutics Expert Committee.

Statistical Approaches to Addressing the Requirements of the New FDA Process Validation Guidance for Small Molecules 1 Jason Marlin, MS/T Statistics, Eli.

1 Dissolution Measurement System: Current State and Opportunities for Improvement Dr. Lucinda Buhse Director, Division of Pharmaceutical Analysis.

Finished Pharmaceutical Product Specifications

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

PHARM 462 PART / /31 Good Manufacturing Practices (GMP) VALIDATION of ANALYTICAL TEST METHODS.

Pharmaceutical Nomenclature Issues and challenges Moheb M. Nasr, Ph.D. Acting Director Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee.

Office of New Drug Chemistry, OPS, CDER, Food and Drug Administration Establishing Dissolution Specification Current CMC Practice Vibhakar Shah, Ph.D.

Challenges and Opportunities in Enhancement of the CMC Section of NDAs: Quality – by - Design Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical.

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

PAT Validation Working Group Process and Analytical Validation Working Group Arthur H. Kibbe, Ph.D. Chair June 13, 2002.

1 Revisions to 21 CFR Supplements and Other Changes to an Approved Application PhRMA Perspective FDA Public Meeting – 7 Feb 2007.

FDA Nasal BA/BE Guidance Overview

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

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

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

Analysis and Visualization Approaches to Assess UDU Capability Presented at MBSW May 2015 Jeff Hofer, Adam Rauk 1.

2015 MBSW1 Quality Assurance Test of Delivered Dose Uniformity of Multi-dose Spray and Inhalation Drug Products Drs. Yi Tsong 1, Xiaoyu (Cassie) Dong*

1 Bioequivalence of Highly Variable Drugs: Regulatory Perspectives Sam H. Haidar, R.Ph., Ph.D. Pharmacometrics Office of Generic Drugs.

FDA Regulation of Drug Quality: New Challenges Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research, Food and Drug Administration April.

John R. MurphyACPS 10/ Zero Tolerance Criteria Do Not Assure Product Quality John R. Murphy, Ph.D. Meeting of the Advisory Committee for Pharmaceutical.

1 Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July , 2008 Classification of Orally Disintegrating Tablets Frank O. Holcombe,

Introduction to Topic #1: QbD approach for quality control and assurance of Dissolution Rate Ajaz S. Hussain, Ph.D. Deputy Director, Office of Pharmaceutical.

Parametric Tolerance Interval Test for Delivered Dose Uniformity (DDU) Working Group Update Moheb M. Nasr, Ph.D. Office of New Quality Assessment (ONDQA,

1 Regulatory Aspects of Pharmaceutical Excipients PQRI Workshop Nick Buhay Acting Director Division of Manufacturing and Product Quality Office of Compliance.

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

<701> DISINTEGRATION

Overview of FDA's Regulatory Framework for PET Drugs

Risk-Based CMC Review - OGD Perspective Gary J. Buehler, R.Ph. Director Office of Generic Drugs July 21, 2004 Advisory Committee for Pharmaceutical Science.

The USP Performance Test Dissolution Systems Suitability Studies Walter W. Hauck, Ph.D. USP Consultant Presentation to Advisory Committee for Pharmaceutical.

Meiyu Shen, PhD Collaborators: Xiaoyu Dong, Ph.D., Yi Tsong, PhD

Bioequivalence of Locally Acting Gastrointestinal Drugs: An Overview

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

Blend Uniformity: Update Ajaz S. Hussain, Ph.D.. Background Issue: Assuring and documenting “adequacy of mixing” operations –PQRI’s Proposal Stratified.

Module 4Slide 1 of 23 WHO - EDM Validation Basic Principles of GMP.

1 Dose Content Uniformity for Aerosol Products Wallace P. Adams, Ph.D. OPS/IO Advisory Committee for Pharmaceutical Science 13 March 2003 Rockville, MD.

Vinod P. Shah, Ph. D Pharmaceutical Consultant (Formerly with US FDA)

1 PTIT for DCU of OINDP: Approaches to Resolution of Identified Issues Wallace P. Adams, Ph.D. OPS/IO Advisory Committee for Pharmaceutical Science 21.

Module 12 - part 2Slide 1 of 23 WHO - EDM Basic Principles of GMP Documentation Part 2 Part One, 14.

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.

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

Quality Assurance of Medicines under Universal Health Coverage Program by Siriwat Tiptaradol (Presenter) Duangporn Abhigantaphand Sooksri Ungboriboonpisal.

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

BSC Biowaiver: Components, Requirements and Criteria

USP: Water for Pharmaceutical Purposes NCSLI – Metrological Traceability in Pure Water Testing August 22, 2011 Antonio Hernandez-Cardoso Senior Scientific.

Ajaz S. Hussain, Ph.D. Office of Pharmaceutical Sciences CDER, FDA October 21, 2003 Dose Content Uniformity: Parametric Tolerance Interval Approach.

Office of Pharmaceutical Science OPS Center for Drug Evaluation and Research CDER FDA Food and Drug Administration HHS Health and Human Services 1 Advisory.

1. Our Presentation Topic: Importance Of Validation & Qualification In Pharmaceutical Industries Presented By: Md. Tanjir Islam (Group C) 2.

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

An Assessment of IPAC-RS’ Proposal Walter W. Hauck, Ph.D. Biostatistics Section Division of Clinical Pharmacology Thomas Jefferson University Philadelphia,

Version: 27 May 2007 New Models for Collaboration: Patients as Drivers and Partners in Neurological Research Integrating Patient Input Within the Drug.

Ensuring quality of medicines procured with Global Fund resources HIV AIDS conference Satellite on Essential Medicines for HIV AIDS Mexico 6 August 2008.

HOLD-TIME STUDIES.

POST APPROVAL CHANGE MANAGEMENT PROTOCOLS IN THE EUROPEAN UNION

Strengthening National Quality Infrastructure in the Lao PDR

Physico-chemical Control of Dosage Forms

World Health Organization

Introduction What is a Biowaiver?

Uncontrolled variation is the enemy of quality

Producing a Pharmaceutical or Biopharmaceutical

USP and Dissolution Testing

PAI Readiness For Seven ANDA Products

Analytical Method Validation PAI Readiness / Certification

Jyh-Ming Shoung and Stan Altan

Evaluation of tablet dosage form 5) dissolution

SID & GP MINPROMTORG OF RUSSIA Corporate Communication Center

PROCESS VALIDATION - ACTUAL REGULATION, PERFORMING AND INSPECTION

Presentation transcript:

USP and Dissolution Testing Advisory Committee for Pharmaceutical Sciences 2 May 2005 Will Brown Staff Liaison to the Biopharmaceutics Expert Committee Department of Standards Development

Biopharmaceutics Expert Committee 2005-2010 Thomas Foster, chair Diane Burgess Bryan Crist Mario Gonzalez Vivian Gray Johannes Krämer Lewis Leeson Alan Parr James Polli Leon Shargel Eli Shefter William Simon Clarence Ueda David Young

The USP Performance Test Dissolution or Disintegration Tests within the specification for a dosage form Procedure Acceptance Criteria <711> Dissolution General description of techniques Modified case-by-case: monograph

The USP Performance Test Study design and analysis: S1, S2, S3 Number of units tested fixed for each stage Acceptance criteria determined by FDA working with Applicants (NDA’s and ANDA’s) Details of the test communicated by sponsor (Applicant) Testing by attribute: pass or fail Some control over distribution: e.g., Q-25% at S3

Biopharmaceutics Expert Committee Workplan includes revising General Chapters to have a performance test by dosage form by route of administration Intention of working with FDA and pharmaceutical manufacturers as appropriate Advisory panels formed in 2000-2005 cycle

Meetings can be productive 1993 FDA Advisory Committee Follow-on IR and ER Guidance documents Pharmaceutical Discussion Group Harmonization for Dissolution and Disintegration General Chapters

Theoretical Approaches W Hauck et al., Oral Dosage Form Performance Tests: New Dissolution Approaches Pharm Res 22(2):182-187, 2005 Explicit hypothesis testing Parametric tolerance intervals Improved way to set dissolution acceptance criteria More flexible protocol design to assess conformity

Theoretical Approaches Allow industry more control on study design Tiers possible Number of units within tiers Can differ between manufacturers Set P value (fraction of units in the reference batch that must conform) Risk clearly assessed, managed and communicated Corresponds to approaches for uniformity of metered dose inhalers (Wednesday session)

Calibrators GMP-related concept Done occasionally (six month maximum) Rule out test assemblies that do not perform, extremes Inter-Laboratory variability is a major contributor to width of ranges but must be captured Criteria derived from analysis of data collected in collaborative studies Acceptable values fall in ranges representing performance by the “best of the best”

Calibrators Salicylic Acid Tablets Prednisone Tablets Unit packaging Prednisone Tablets Scale up from U of Md batches (reproduction of NCDA#2) New batch in production Theophylline Beads Deleted from system suitability requirement for Apparatus 3 Reciprocating Cylinder

Thank you for your attention