Balancing the time, cost and risk of drug development. Christina Gustafsson, PhD Pharm, Formulation Scientist at Pharmaceutical Development, APL
|
|
- Joel Burns
- 6 years ago
- Views:
Transcription
1 Balancing the time, cost and risk of drug development Christina Gustafsson, PhD Pharm, Formulation Scientist at Pharmaceutical Development, APL
2 Communicating vessels Risk Time Cost
3 Communicating vessels Risk Time Cost
4 From drug substance to Investigational Medicinal Product (IMP)
5 From drug substance to Investigational Medicinal Product (IMP) Formulation Manufacturing process Analytical method Packaging Efficasy Safety Stability Uniformity of dosage Appearance Price Patient acceptability Ability to patent
6 Our experiences being a CRO/CMO what does the customer want? Keep it as simple as possible we only want to show proof of concept Skip excipients as far as possible Low cost But the choice of formulation may affect clinical results and the possibility of further scale up and manufacturing
7 Risk assessment during formulation A simple formulation in early clinical trials may be acceptable, but then work in parallell to develop a formulation suitable for scale up, later clinical phases and for commercial manufacturing Be aware of the drug substance (DS) batch to batch variation is common during process development and scale up of manufacturing of DS! How robust/forgiving is your formulation, will it compensate for changes in DS? Particle size and particle size distribution Particle shape and surface roughness Polymorphs, changes in crystallinity/amorphous content Solubility
8 Example No 1: Batch variations and robustness of formulation Particle size distribution of DS changed between first and second manufacturing of clinical material for capsule formulation When DS particle distribution changed, mixing with excipients did not result in homogenous powder mixture anymore Customer did not want to change excipients since one clinical trial already had been performed Need for micronization -> delay of 6 months
9 Example No 2: A quick solution may be costful Capsule formulation where a new lower dose of the drug is wanted quickly Earlier development had shown lump formation during mixing of lower dose filled in the same capsule size Solution: Use excisting powder mixture but fill in smaller capsule size and modify mixing process Result: IMP possible to manufacture but problems to obtain robust filling process due to low filling weight causing deviations and need for capsule weight sorting What would we have done if we had more time: Developed new composition without tendency of lump formation
10 Example No 3: Development is not full scale a) A gel developed in small scale Customer wants to take the risk to do scale up to 4 kg directly -> Results: Mixing technique showed to be insufficient to prevent lump formation b) Ointment developed in small scale During scale up to 50 kg batch size, one excipient in the formulation is burned at the higher temperatures generated during mixing in larger scale
11 Example No 4: Do not discard alternatives to early Formulation development of semi-solid where customer chooses to put only one of five developed formulations on stability study Accelerated stability study 40 C for one month show no deviations The product shows to turn granular when stored in room temperature after 2 months, i.e. before 3 months stability pull point Consequence: Restart with three new compositions that are manufactured and put on stability study
12 Example No 5: The importance of compatibility studies Compatibility study performed with potential excipients for oral product suggested to be wet granulated in order to develop both capsule and tablet formulation Stability study shows that wet granulated formulation is not stable in any composition with suggested excipients No delay since dry mixing compositions also was included the rather extensive compatibility testing matrix
13 Conclusions Balance the formulation development work based on the what the DS needs and requirements of the final product Work if possible in parallel with development for larger scale if very simple formulation is chosen initially What is gained in time with simple formulation for quick start Balance of clinical trials may easily be lost or reduced in value if the DS is changed or the manufacturing process shows not to work in formulation development lager scale DS with is always work based on the when what the knowledge needs of the final product
AdaptDose, an innovative platform that reduces product development time and costs by 30% or more
WHITE PAPER January 2017 AdaptDose, an innovative platform that reduces product development time and costs by 30% or more Frontida BioPharm, Inc. Ron Connolly 01.01.2017 CONTENTS ABSTRACT INTRODUCTION
More informationDECISION TREE #1: ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A NEW DRUG SUBSTANCE
DECISION TREE #1: ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A NEW DRUG SUBSTANCE Determine impurity level in relevant batches 1 Determine mean + upper confidence limit for the impurity
More informationGuidelines for Pharmaceutical Equivalence Requirements
Guidelines for Pharmaceutical Equivalence Requirements Version 1.1 1 September 2010 Page 1 of 9 Guidelines for Pharmaceutical Equivalence Requirements Version 1.1 Drug Sector Saudi Food & Drug Authority
More informationOral Dosage Formulation Development
Oral Dosage Formulation Development Achieving faster formulation of solid oral dosage forms for FIH supplies Dr. Colin Lorimer - published April 29, 2011 The pharmaceutical industry is increasingly looking
More informationMETHOCEL. TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow
METHOCEL Cellulose Ethers A product that can do it all TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow The possibilities are endless Pharmaceutical companies are continuously
More informationInstitute of Pharmaceutical Technololgy and Biopharmacy University of Pécs
Institute of Pharmaceutical Technololgy and Biopharmacy University of Pécs 1 Faculty of Pharmacy H-7624 Pécs, Rókus str.2. 2 Faculty of Pharmacy Department of Pharmacetical Biotechnology Department of
More informationFormulation Development & CTM Manufacturing Services
Formulation Development & CTM Manufacturing Services VxP Pharma Purdue Research Park 5225 Exploration Drive Indianapolis, IN 46241 Tel: 317.759.2299 Fax: 317.713.2950 VxP Pharmaprovides an extensive range
More informationQUALITY OF PROLONGED RELEASE ORAL SOLID DOSAGE FORMS
QUALITY OF PROLONGED RELEASE ORAL SOLID DOSAGE FORMS Guideline Title Quality of Prolonged Release Oral Solid Dosage Forms Legislative basis Directive 75/318/EEC as amended Date of first adoption October
More informationDeveloping new drug products is very expensive, especially
As appeared in March 2018 Tablets & Capsules www.tabletscapsules.com formulation Developing fixed-dose combinations Amar Patel, Bruhalkumar Shah, Deep Patel, Satish Shetty, and Anthony Qu Halo Pharmaceuticals
More informationBioavailability and Bioequivalence Studies
Bioavailability and Bioequivalence Studies Standard Approach Part I: Design and Conduct H. Rettig, Ph.D. LLC www.ivivc.com Note for Guidance on the Investigation of Bioavailability and Bioequivalence CPMP/EWP/QWP/1401/98
More informationDEVELOPMENT PHARMACEUTICS AND PROCESS VALIDATION
DEVELOPMENT PHARMACEUTICS AND PROCESS VALIDATION Guideline Title Development Pharmaceutics and Process Validation Legislative basis Directive 75/318/EEC as amended Date of first adoption April 1988 Date
More informationHow to Identify Critical Quality Attributes and Critical Process Parameters
How to Identify Critical Quality Attributes and Critical Process Parameters Jennifer Maguire, Ph.D. Daniel Peng, Ph.D. Office of Process and Facility (OPF) OPQ/CDER/FDA FDA/PQRI 2 nd Conference North Bethesda,
More informationMeeting Solid Dose Formulation Challenges
Streamlining (Fast Tracking) Solid Dosage Form Development Tony Carpanzano, B.S., R. Ph. Director, Research & Development Streamlining (Fast Tracking) Solid Dosage Form Development Meeting Solid Dose Formulation
More informationOutline CLINICALLY RELEVANT SPECIFICATIONS. ISPE Process Validation Conference September 2017 Bethesda, MD
CLINICALLY RELEVANT SPECIFICATIONS Patrick J Marroum Ph.D. Senior Director and ACOS Senior Research Fellow Department of Clinical Pharmacology and Pharmacometrics Abbvie Pharmaceuticals Outline CMC variables
More informationFormulations for clinical trials in children: possibilities and pitfalls? Robert Ancuceanu, PhD Member of PDCO and FWG
Formulations for clinical trials in children: possibilities and pitfalls? Robert Ancuceanu, PhD Member of PDCO and FWG Formulation two meanings Process in which different ingredients, including the active
More informationQuality by Design and Expertise: Accelerating time to market of complex oral solid dosage forms
CPhI Worldwide 2017 October 24 th -v 26 th, 2017 Frankfurt Quality by Design and Expertise: Accelerating time to market of complex oral solid dosage forms Lucile KOWALSKI - NPI Project Manager Guy VERGNAULT
More informationRoller compactors for the pharmaceutical industry. BT 120 Pharma WP 120 Pharma WP 150 Pharma WP 200 Pharma
Roller compactors for the pharmaceutical industry BT 120 Pharma WP 120 Pharma WP 150 Pharma WP 200 Pharma Roller compactors for the pharmaceutical industry Compaction and granulation in the pharmaceutical
More informationQ8 Pharmaceutical Development
Q8 Pharmaceutical Development For questions regarding this draft document contact (CDER) Ajaz Hussain at 301-594-2847 or (CBER) Christopher Joneckis at 301-435-5681. This draft guidance, when finalized,
More informationHow to Avoid Common Deficiencies in INDs and NDAs. Ramesh Raghavachari, Ph.D. Branch Chief, Branch IX ONDQA/OPS/CDER
How to Avoid Common Deficiencies in INDs and NDAs Ramesh Raghavachari, Ph.D. Branch Chief, Branch IX ONDQA/OPS/CDER 1 Structure of FDA Office of Commissioner Chief Scientist FOODS Medical Products & Tobacco
More informationRapidFACT: Accelerated Formulation Development for Poorly Soluble Drugs and Modified Release Products
RapidFACT: Accelerated Formulation Development for Poorly Soluble Drugs and Modified Release Products Kevin Kane, Scientific Director, BCP 7 th Annual Global Drug Delivery & Formulation Summit 28 th August
More informationEarly Development Best Practices for Stability- Regulatory Perspective
Early Development Best Practices for Stability- Regulatory Perspective IQ Workshop, Feb. 4-5, 2014, Washington, D.C. Ramesh Sood, Ph.D. Division Director (Acting) Office of New Drug Quality Assessment
More informationCOUNT ON US FROM NON-STERILE TO STERILE FROM GELS AND CREAMS TO OINTMENTS AND AEROSOLS FROM CONCEPT TO COMMERCIALIZATION FROM VIRTUAL TO LARGE PHARMA
COUNT ON US FROM NON-STERILE TO STERILE FROM GELS AND CREAMS TO OINTMENTS AND AEROSOLS FROM CONCEPT TO COMMERCIALIZATION FROM VIRTUAL TO LARGE PHARMA WHO WE ARE DPT is a Contract Development and Manufacturing
More informationAdvances in powderdosing
Advances in powderdosing technology A new technology offers a step-change in the way that early clinical trial supplies can be formulated resulting in real savings in development times and costs. Simon
More informationGUIDELINE FOR THE STABILITY TESTING
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 GUIDELINE FOR THE STABILITY TESTING OF NON-PRESCRIPTION (OTC)
More informationAppendices! Product quality documents. Technical guidelines. (Translation from Original Chinese Version)
Appendices! (Translation from Original Chinese Version) Product quality documents Technical guidelines Appendix I General tests for various dose forms of pcms The general tests for various dose forms of
More informationICH Topic M 4 Q Location issues for Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality Questions and Answers
European Medicines Agency August 2003 CPMP/ICH/4680/02 ICH Topic M 4 Q Location issues for Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality Questions and Answers
More informationCommonly Seen Drug Product Related Quality Deficiencies
Commonly Seen Drug Product Related Quality Deficiencies 2016 GPhA CMC Workshop Bethesda, MD; May 18, 2016 Geoffrey Wu, PhD, CPH Lieutenant, US Public Health Service Associate Director for Science & Communication
More informationCHALLENGES & OPPORTUNITIES OF ICHQ8 (PHARMACEUTICAL DEVELOPMENT) AN INDUSTRY PERSPECTIVE
CHALLENGES & OPPORTUNITIES OF ICHQ8 (PHARMACEUTICAL DEVELOPMENT) AN INDUSTRY PERSPECTIVE Paul Stott, PhD Head of US Product Development AstraZeneca ICH Quality Guidelines Workshop BioKorea 2007 Sept 13-14
More informationUSP s Perspective on Drug Product Performance Test
USP s Perspective on Drug Product Performance Test Course Overview 1. The concept of in vitro dissolution Definition and application 2. Compendial dissolution/ drug release testing 3. Method development
More informationPharmaceutical Development (Drug Substance & Drug Product) for Visceral Leishmaniasis candidate DNDI-6148
Request for Proposal Pharmaceutical Development (Drug Substance & Drug Product) for Visceral Leishmaniasis candidate DNDI-6148 Dated: October 12 th 2015 Page 1 Table of Contents 1. PURPOSE... 3 2. RFP
More informationConducting Successful pre-ind Meetings to Reach FDA Concurrence for Sound 505(b)(2) Development
Conducting Successful pre-ind Meetings to Reach FDA Concurrence for Sound 505(b)(2) Development 2015 AAPS Annual Meeting and Exposition October 28, 2015 Kimberly Raines, Ph.D. Lead Pharmacologist Quality
More informationWHOPAR. SCIENTIFIC DISCUSSION
This part reflects the scientific knowledge and the information about this product available at the time of prequalification. Thereafter, updates may have become necessary which are included in parts 1
More informationINTER CHANGEABILITY and EQUIVALENCE. Where we are and what we still have to determine!
INTER CHANGEABILITY and EQUIVALENCE Where we are and what we still have to determine! Acknowledgement Joint presentation UNICEF/MSF/ICRC Cecile Mace Jean Michel Caudron Birgit Schmauser What do we mean
More informationProcess Drift: When Do We Detect it? Richard L. Friedman Director, DMPQ CDER/Office of Compliance PQRI Process Drift Workshop December 1, 2010
Process Drift: When Do We Detect it? Richard L. Friedman Director, DMPQ CDER/Office of Compliance PQRI Process Drift Workshop December 1, 2010 Overview Goal of Manufacturing Central Question: Why is process
More informationRisk Management in Drug Product Manufacturing with Emphasis on Batch Documentation/Execution
Risk Management in Drug Product Manufacturing with Emphasis on Batch Documentation/Execution Manufacturing Breakout Session I Jack Pellett (Genentech) and Eleni Dokou (Vertex) What are typical lead-times
More informationSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS
More informationProviding insight into pharmaceutical formulations
Providing insight into pharmaceutical formulations Dr Steve Ward-Smith Pharmaceutical Industry The average cost of developing a drug is reported to be approx $500 million, but up to 70% of new chemical
More informationIndustry Perspective on Manufacturing in Early Development
Industry Perspective on Manufacturing in Early Development IQ Workshop, Feb 4-5, 2014, Washington, D.C. Eric Schmitt AbbVie IQ Drug Product Manufacturing Working Group August 2012 issue of Pharmaceutical
More informationComplexity of Retention Samples Selection in non-traditional Bioequivalence studies
Complexity of Retention Samples Selection in non-traditional Bioequivalence studies Nageshwar R Thudi Ph.D. Director-Clinical R&D Teva Pharmaceuticals Disclaimer The views expressed herein are the views
More informationScientific and Regulatory Considerations for Continuous Manufacturing Implementation for Drug Product
Scientific and Regulatory Considerations for Continuous Manufacturing Implementation for Drug Product Arwa El Hagrasy, Ph.D. Quality Assessment Lead (Acting) Office of Process and Facilities OPQ/FDA PQRI
More informationReview and highlight existing guidance documents that address pharmaceutical stability and supply chain issues. 3.) Solution
Translating the Requirements of Thermal Cycling / Excursion Guidelines Through the Use of a Comprehensive Risk Management Matrix for Time and Temperature Sensitive Pharmaceutical Products Curtis Strother,
More informationAn Overview of IQ s Position Paper: Early Development GMPs for Small-Molecule Specifications
An Overview of IQ s Position Paper: Early Development GMPs for Small-Molecule Specifications On behalf of Specifications Team Kirby Wong-Moon, Ph.D. Amgen Inc. Best Practices and Application of GMPs for
More informationGuidance for Industry
Guidance for Industry ANDAs: Blend Uniformity Analysis DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should
More informationExtractables & Leachables. Ophthalmic Drug Products: A Regulatory Perspective Current Industry Challenges and Case Studies
Extractables & Leachables Ophthalmic Drug Products: A Regulatory Perspective Current Industry Challenges and Case Studies Ph.D. Pfizer Global Research and Development Bethesda 23/02/2011 Thresholds and
More informationOur vision APL
Our vision We want be the most attractive partner and workplace for development and manufacturing of extemporaneous drug formulations and pharmaceuticals. APL 2018 2 Our task Our task is to develop and
More informationBiowaiver Approaches for Solid Oral Dosage Forms in New Drug Applications Poonam R. Delvadia, Ph.D. Division of Biopharmaceutics\ONDP\OPQ\CDER\FDA
Biowaiver Approaches for Solid Oral Dosage Forms in New Drug Applications Poonam R. Delvadia, Ph.D. Division of Biopharmaceutics\ONDP\OPQ\CDER\FDA PQRI BTC Webinar December 06, 2018 DISCLAIMER The presentation
More informationMG2 and Valpharma: together for the improvement of the production process
Newsletter 2 - April 2012 MG2 and Valpharma: together for the improvement of the production process Quality is not achieved only with a good production but also through knowledge of the production process,
More informationQuality by Design (QbD)
Evaluating the Critical Quality attributes & Critical Process Parameters-A Case Study-Tablets GMP International Workshop February 20/21, 2008 Mumbai, India Mukund Yelvigi Director, Therapeutic Area Management,
More informationDesign and Dosage Form. Dr. Deny Susanti
Design and Dosage Form Dr. Deny Susanti Example 1 Aspirin tablet is stable but not as a liquid dosage form How to design liquid form? Soluble or dispersible aspirin tablets-to be dissolved in water Note:
More informationPHARMACEUTICAL MANUFACTURING
PHARMACEUTICAL MANUFACTURING WHAT IS PHARMACEUTICAL MANUFACTURING IT IS THE PROCESS OF INDUSTRIAL SCALE SYNTHESIS OF PHARMACEUTICAL DRUG BY PHARMACEUTICAL COMPANIES. THE PROCESS CAN BE BROKEN DOWN INTO
More informationMOISTURE CONTENT MEASUREMENT CASE STUDY
MOISTURE CONTENT MEASUREMENT CASE STUDY This case study is based on a large research-focused health care company with a long tradition in pharmaceutical production and diagnostics. The company was founded
More informationA STANDARD PROTOCOL for DERIVING and ASSESSMENT of STABILITY. Part 3 Oral Liquid Medicines (Solutions, Emulsions, Suspensions and Syrups)
A STANDARD PROTOCOL for DERIVING and ASSESSMENT of STABILITY Part 3 Oral Liquid Medicines (Solutions, Emulsions, Suspensions and Syrups) EDITION 1 August 2014 NHS Pharmaceutical Quality Assurance Committee
More informationQuality by Design, Revolution or Evolution? Wim Oostra
Quality by Design, Revolution or Evolution? Wim Oostra 1993 1998 2007 2009 2013 And many more.. Content Introduction A bit of history Examples A New product Legacy product Today? The triggers The goal
More informationAt LATITUDE, we only do one thing, and we do it very well.
Formulation Experts for Insoluble Compounds At LATITUDE, we only do one thing, and we do it very well. LATITUDE Pharmaceuticals Inc. has been tackling the most difficult drug formulation challenges for
More informationFROM CLINICAL TO COMMERCIAL CUSTOM CAN. An overview of our Development and Manufacturing capabilities
FROM CLINICAL TO COMMERCIAL CUSTOM CAN An overview of our Development and Manufacturing capabilities THE CUSTOM DIFFERENCE Established in 1979, Custom Pharma Services has grown to become the go-to resource
More informationGUIDELINES FOR INTRODUCING A LOCALLY MANUFACTURED NEW PHARMACEUTICAL PRODUCT ON THE UGANDA MARKET
GUIDELINES FOR INTRODUCING A LOCALLY MANUFACTURED NEW PHARMACEUTICAL PRODUCT ON THE UGANDA MARKET National Drug Authority Head Office Rumee Towers Plot 19, Lumumba Avenue P. O. Box 23096 Kampala, Uganda
More informationQuality Issues for Clinical Trial Materials: The Chemistry, Manufacturing and Controls (CMC) Review
Quality Issues for Clinical Trial Materials: The Chemistry, Manufacturing and Controls (CMC) Review Presented by Erika E. Englund, Ph.D. Slides courtesy of Dorota Matecka, Ph.D. Office of Pharmaceutical
More informationNUVISAN GROUP. Our Philosophy
NUVISAN GROUP Our Philosophy 2 EARLY DEVELOPMENT Introduction to Nuvisan Fully integrated Contract Research Organisation headquarted in Neu-Ulm, southern part of Germany. Nuvisan - Early Development Headquartered
More informationCHECKLIST FOR VARIATIONS APPLICATIONS FOR MEDICINES
CHECKLIST FOR VARIATIONS APPLICATIONS FOR MEDICINES INTRODUCTION: This document describes the requirements of a Variation application submitted for an existing application for registration of medicine
More informationApproval Review of Generic Drugs. Office of Generic/OTC Drugs, PMDA Kazuyuki SAITO, Ph.D.
Approval Review of Generic Drugs Office of Generic/OTC Drugs, PMDA Kazuyuki SAITO, Ph.D. Outline of Presentation Introduction Approval Review of Generic Drugs Equivalency review Conformity audit Conclusion
More informationFederal Institute for Drugs and Medical Devices ICH-Leitlinie Q 8 - Pharmaceutical Development die regulatorische Perspektive
ICH-Leitlinie Q 8 - Pharmaceutical Development die regulatorische Perspektive Dr. Susanne Keitel Swiss Association for Quality Olten, 28. Juni 2006 1 Overview of the Presentation ICH Q 8: background and
More informationPharmaceutical Sciences
SRI International Biosciences From Idea to IND Research on Disease Mechanisms Drug Discovery Drug Metabolism, Pharmacokinetics, & Toxicology Services Pharmaceutical Sciences Preclinical Development Planning
More informationA Science Based Approach for Topical Drug Classification System
A Science Based Approach for Topical Drug Classification System Vinod P. Shah, Ph.D., FAAPS, FFIP. Pharmaceutical Consultant, (Formerly with US FDA) North Potomac, MD., USA Disso Europe 2016 Romania Advances
More informationDEVELOPING AN IN VITRO RELEASE TESTING (IVRT) METHOD FOR THE VALIDATION OF SEMI-SOLID TOPICAL FORMULATIONS
DEVELOPING AN IN VITRO RELEASE TESTING (IVRT) METHOD FOR THE VALIDATION OF SEMI-SOLID TOPICAL FORMULATIONS EXECUTIVE SUMMARY The effective measurement of drug release of an active pharmaceutical ingredient
More informationSCIENTIFIC DISCUSSION
This part reflects the scientific knowledge and the information about this product available at the time of prequalification. Thereafter, updates may have become necessary which are included in parts 1
More informationCleaning and Cleaning Validation of API Plant and Equipment
Regulatory Basis: FDA Quality Systems Regulations Reference: FDA CFR - Code of Federal Regulations Title 21 1 Purpose The purpose of this guideline is: To define the requirements for cleaning plant and
More informationINTRODUCTION TO INDUSTRIAL PHARMACY LAB 1
INTRODUCTION TO INDUSTRIAL PHARMACY LAB 1 LAB INSTRUCTORS: LECT. ANAS T ARIK NAFEA ASSIST. LECT. ZAINAB HASSAN MAHDI Definition of Industrial Pharmacy The conversion of raw materials into certain dosage
More informationPublic Assessment Report. Scientific discussion. Progesteron GLF 100 mg and 200 mg soft capsules. (progesterone) NL/H/3415/ /DC
Public Assessment Report Scientific discussion Progesteron GLF 100 mg and 200 mg soft capsules (progesterone) 001-002/DC Date: 6 June 2017 This module reflects the scientific discussion for the approval
More informationGUIDANCE DOCUMENT Use of a Foreign-sourced Reference Product as a Canadian Reference Product
GUIDANCE DOCUMENT Use of a Foreign-sourced Reference Product as a Canadian Reference Product Published by authority of the Minister of Health Date Adopted 2017/11/24 Effective Date 2017/11/24 Health Products
More informationICH Q9 An Industry Perspective: Ensuring Quality to Patients in a Risk-Based Regulatory Environment
ICH Q9 An Industry Perspective: Ensuring Quality to Patients in a Risk-Based Regulatory Environment Thomas Schultz, Ph.D. Director, Regulatory Sciences Johnson & Johnson September 12, 2007 Presentation
More informationEvaluation of Gel Formulations by Quality by Design Concept
Human Journals Review Article March 2019 Vol.:14, Issue:4 All rights are reserved by Rahul Kumar Nagaria et al. Evaluation of Gel Formulations by Quality by Design Concept Keywords: Quality by design,
More informationSession 7 Clinical Trial Assessment Bioequivalence Studies
L1 Session 7 Clinical Trial Assessment Bioequivalence Studies Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office
More informationAccelerating development of enabled formulations for poorly soluble drugs
Accelerating development of enabled formulations for poorly soluble drugs John McDermott, Executive Director, Drug Product Optimisation Efficacy issues due to inadequate gastrointestinal (GI) absorption
More informationUniversity of Groningen. Orodispersible films as pharmacy preparations Visser, Johanna Carolina
University of Groningen Orodispersible films as pharmacy preparations Visser, Johanna Carolina IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from
More informationDevelopment of paediatric formulations - points to consider
Development of paediatric formulations - points to consider Workshop on Paediatric Formulations II London, 8 November 2011 Presented by: Ann Marie Kaukonen Scientific Administrator, Paediatric Medicines,
More informationApplication of Quality by Design (QbD) in product development. James E. Polli September 16, 2015
Application of Quality by Design (QbD) in product development James E. Polli jpolli@rx.umaryland.edu September 16, 2015 Pharmaceutical Equivalence Same active ingredient(s) Same dosage form Same route
More informationQbD implementation in Generic Industry: Overview and Case-Study
QbD implementation in Generic Industry: Overview and Case-Study Inna Ben-Anat, QbD Strategy Leader, Teva Pharmaceuticals IFPAC JAN 2013 R&D Three Core Components of QbD and Generic Industry: How Do They
More informationHermes_highlights_need_for_better_formats_OTCBulletin_ pdf. Published July Accessed July 10, 2016.
Introduction An online survey conducted in the United States found that 50% of surveyed American adults (N = 1002) reported difficulty swallowing tablets and capsules. 1 These numbers are even higher in
More informationEvolution of Quality Assessments Recent Trends in FDA Queries. Mike Saleh, Pfizer Inc.
Evolution of Quality Assessments Recent Trends in FDA Queries Mike Saleh, Pfizer Inc. Outline 1. Background 2. Assessment of Information Requests from Recent NDAs 3. Distribution of queries (by focus area)
More informationThe science of transforming an Active Pharmaceutical Ingredient (API) into a Drug Product (DP) in a specific dosage form.
The science of transforming an Active Pharmaceutical Ingredient (API) into a Drug Product (DP) in a specific dosage form. Three major needs that the formulation into a specific dosage form directly address
More informationInternationally harmonised requirements for batch certification
1 June 2011 EMA/INS/MRA/387218/2011 Rev 5 Compliance and Inspection Internationally harmonised requirements for batch certification in the context of Mutual Recognition Agreements, Agreements on Conformity
More informationFormulation Development of New Chemical Entities (NCEs) Dr. Mariella Artusi Pharmaceutical Development Dept. Monza
Formulation Development of New Chemical Entities (NCEs) Dr. Mariella Artusi Pharmaceutical Development Dept. Monza HorizonChem 2018, March, 6th 2018 1 Content Rottapharm Biotech : Company Overview Formulation
More informationManual 055 Commercial Stability Testing For Formulated Products. This procedure applies to all drug products. The procedure covers:
1 Purpose Manual 055 Commercial Stability Testing For Formulated Products The intent of this procedure is to provide to manufacturing and primary packaging sites the principles of a stability program.
More informationCLINICAL REQUIREMENTS FOR LOCALLY APPLIED, LOCALLY ACTING PRODUCTS, CONTAINING KNOWN CONSTITUENTS
CLINICAL REQUIREMENTS FOR LOCALLY APPLIED, LOCALLY ACTING PRODUCTS, CONTAINING KNOWN CONSTITUENTS Guideline Title Clinical Requirements for Locally Applied, Locally Acting Products, Containing Known Constituents
More informationIntertek Melbourn Company Presentation. MIBio 2016
Intertek Melbourn Company Presentation MIBio 2016 November 2016 Global Leader in quality solutions across all industries Innovative and bespoke quality solutions for our clients 24/7 FTSE 100 company in
More informationCOMMON DEFICIENCIES IN FINISHED PHARMACEUTICAL PRODUCT (FPP) DOSSIERS
COMMON DEFICIENCIES IN FINISHED PHARMACEUTICAL PRODUCT (FPP) DOSSIERS Additional guidance for manufacturers This note identifies the most common quality related deficiencies in recently assessed dossiers
More informationMINISTRY OF HEALTH AND SOCIAL SERVICES
MINISTRY OF HEALTH AND SOCIAL SERVICES NAMIBIA MEDICINES REGULATORY COUNCIL POST REGISTRATION AMENDMENT GUIDELINES These guidelines are meant to provide assistance to industry and health care professionals
More informationFOOD AND DRUGS AUTHORITY
G H A N A FOOD AND DRUGS AUTHORITY GUIDELINES FOR STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED PHARMACEUTICAL PRODUCTS Document No: FDA/DRI/DER/GL-STP/2013/07 Date of First Adoption:
More informationA HYBRID INTELLIGENT SYSTEM FOR FORMULATION OF BCS CLASS II DRUGS IN HARD GELATIN CAPSULES
A HYBRID INTELLIGENT SYSTEM FOR FORMULATION OF BCS CLASS II DRUGS IN HARD GELATIN CAPSULES Gunjan Kalra, Yun Peng Laboratory of Advanced Information Technology Dept. of Computer Science And Electrical
More information7th Training School on Microencapsulation Strasbourg. Februar 2015 Textmasterformat in Mastervorlage eingeben
7th Training School on Microencapsulation Strasbourg Februar 2015 1 Dr. Anne Ettner, Glatt Pharmaceutical Services 2 Overview 1. Introduction 2. Fluid bed equipment 3. Basics of fluid bed Wurster technology
More informationPHARMACEUTICAL PRINCIPLES OF SOLID DOSAGE FORMS
PHARMACEUTICAL PRINCIPLES OF SOLID DOSAGE FORMS J. T. Carstensen, Ph.D. Professor of Pharmacy University of Wisconsin Madison, Wisconsin TECHNOMIC ^PUBLISHING CO.. INC J 1.ANCASTER BASET, TABLE OF CONTENTS
More informationDrivers for Continuous Tablet Manufacturing in Pharmaceutical Industry
Drivers for Continuous Tablet Manufacturing in Pharmaceutical Industry Satu Lakio PhD (pharm.), Adj. Prof. Industrialisation and product life cycle management Orion Pharma 29th Annual Symposium of the
More informationThe GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products EDITION TWO 1428 H 2007 G
The GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products EDITION TWO 1428 H 2007 G (1) INTRODUCTION The following guideline defines the stability data package for a drug
More informationHPMC Capsules Sealing with Capsugel CFS1200 Equipment for Small Scale Laboratory Development
HPMC Capsules Sealing with Capsugel CFS00 Equipment for Small Scale Laboratory Development S. Robin, J. Cuevas, D. Cade Chemical R&D Department, Capsugel France, Division of Pfizer Dominique.Cade@pfizer.com
More informationPerformance Testing of Novel Dosage Forms
RQA Ireland Regional Forum - Athlone, May 2016 Quality Considerations Pharma and Biopharma Performance Testing of Novel Dosage Forms Terry Way BPharm MAPS Dissolution Science Consultant Glasside Technologies
More informationADVANTAGES OF MULTIPARTICULATES (PELLETS):
INTRODUCTION: Multiparticulate Drug Delivery Systems (MDDS): The concept of multiple unit dosage form was initially introduced in the early 1950 s.these forms play a major role in the design of solid dosage
More informationThe 13th ICDRA (16-19 September) Regulatory Approaches to proving Interchangeability. WHO Biowaiver Guideline in Regulatory Practice
The 13th ICDRA (16-19 September) Regulatory Approaches to proving Interchangeability WHO Biowaiver Guideline in Regulatory Practice Dr Kamel IDDIR General Director Medicines and Pharmacy Directorate Berne
More informationPharmaceutical Manufacturing Technology Centre
Pharmaceutical Manufacturing Technology Centre Research themes for Initial Research Programme Call for Proposals The Centre will focus on advanced pharmaceutical manufacturing technologies with an initial
More informationFirst UNGAP meeting Food-Drug Interactions Regulatory Aspects
First UNGAP meeting Food-Drug Interactions Regulatory Aspects Leuven, 09 March 2018 Dr. Henrike Potthast HPt COST meeting, Leuven, BE 09 March 2018 Page 1 Disclaimer The presentation reflects the personal
More informationIntroduction to CMC Regulatory Affairs
Introduction to CMC Regulatory Affairs Bharathi Mamidipudi Regulatory Affairs Consultant II Syner-G Pharma Consulting, LLC Northeastern University, Boston November 10, 2016 My Background Experience ~4
More information