establishment of of a a rational rational relationship between between
|
|
- Kristian Blankenship
- 6 years ago
- Views:
Transcription
1 IN IN VITRO VITRO // IN IN VIVO VIVO KORELACIJA Definicija po po USP: USP: The The term term in in vitro vitro -- in in vivo vivo correlation refers refers to to the the establishment of of a a rational rational relationship between between a a biological property, or or a a parameter derived derived from from a a biological property produced by by a a dosage dosage form, form, and and a a physicochemical property or or characteristic of of the the same same dosage dosage form. form. IN IN VITRO VITRO TESTI TESTI PO PO USP USP <701> <701> DISINTEGRATION <711> <711> DISSOLUTION APARATURE aparatura 1 aparatura 2 aparatura 3 aparatura 4 POSTOPKI immediate release release dosage dosage forms forms extended release release dosage dosage forms forms delayed delayed release release dosage dosage forms: forms: metodi metodi A in in B INTERPRETACIJA <724> <724> DRUG DRUG RELEASE Aparati, Aparati, predpisani v monografijah Transdermalni sistemi sistemi aparati aparati 5, 5, 6, 6, 7 1
2 2
3 USP31 3
4 USP31 USP31 4
5 USP31 <1088> <1088> IN IN VITRO VITRO AND AND IN IN VIVO VIVO EVALUATION OF OF DOSAGE FORMS IN IN VITRO VITRO (raztapljanje/sproščanje razvoj razvoj metod) metod) Oblike Oblike s s takojšnjim sproščanjem testiranje sproščanja zahtevano za za vse vse trdne trdne oblike, oblike, pri pri katerih katerih je je za za dosego dosego učinka učinka potrebna absorpcija. Izjeme! Izjeme! Oblike Oblike s s prirejenim sproščanjem testiranje sproščanja zahtevano za za vse vse sisteme, sisteme, pri pri katerih katerih je je za za dosego dosego učinka učinka potrebna absorpcija IN IN VIVO VIVO (SISTEMI S PRIREJENIM SPROŠČANJEM) karakterizacija učinkovine fizikalno kemijske lastnosti lastnosti farmakokinetične lastnosti lastnosti disposition properties farmakodinamične lastnosti lastnosti karakterizacija oblike oblike fizikalno kemijske lastnosti lastnosti farmakokinetične lastnosti lastnosti IN IN VITRO VITRO // IN IN VIVO VIVO KORELACIJA oblike oblike s s prirejenim sproščanjem oblike oblike s s takojšnjim sproščanjem 5
6 NALOGA: V KATERIH OD OD NASLEDNJIH PRIMEROV LAHKO PRIČAKUJEMO DOBRO IN IN VITRO VITRO IN IN VIVO VIVO KORELACIJO? A) A) Učinkovina se se absorbira z z aktivnim transportom B) B) Učinkovina se se sprošča sprošča enakomerno 8 ur ur in in absorbira vzdolž vzdolžcelotnega jejunuma (ne (ne v želodcu, ne ne v ileumu ileumu in in kolonu) kolonu) C) C) Sproščanje poteka poteka z z enakomerno hitrostjo mmol/h, absorpcija pa pa s s hitrostjo 2 2 mmol/h D) D) Sproščanje poteka poteka z z enakomerno hitrostjo 2 2 mmol/h, absorpcija pa pa s s hitrostjo mmol/h IN IN VITRO VITRO // IN IN VIVO VIVO KORELACIJA Definicija po po USP: USP: The The term term in in vitro vitro -- in in vivo vivo correlation refers refers to to the the establishment of of a a rational rational relationship between between a a biological property, or or a a parameter derived derived from from a a biological property produced by by a a dosage dosage form, form, and and a a physicochemical property or or characteristic of of the the same same dosage dosage form. form. 6
7 IN IN VITRO VITRO // IN IN VIVO VIVO KORELACIJA biološka lastnost: lastnost: farmakokinetičen parameter -- plazemski koncentracijski profili: profili: AUC, AUC, Cmax Cmax fizikalno kemijska lastnost: sproščanje učinkovine Nivoji Nivoji korelacije: nivo nivo A: A: najvišja najvišja stopnja stopnja korelacije point-to-point korelacija = celotni celotni profili profili nivo nivo B: B: primerjava parametrov (statističnih momentov): uporaba uporaba VSEH VSEH podatkov! MDT MDT // M(in M(in vivod)t nivo nivo C: C: primerjava v eni eni točki točki t50%, t50%, t90% t90% // AUC, AUC, tmax, tmax, Cmax Cmax Plazemski profil Profil sproščanja 7
8 Plazemski profil Absorpcijski profil Profil sproščanja Absorpcijski profil Profil sproščanja IVIVC 8
Recent FDA Guidance For Industry; BCS Class 1 and 3 August 2015
Recent FDA Guidance For Industry; BCS Class 1 and 3 August 2015 Bryan Crist Scientific Affairs Manager, Agilent Technologies, Dissolution Systems Dissolution Exchange WebEx Bryan.crist@agilent.com August,
More informationClinically Relevant Specifications (CRS): A Regulatory Perspective
Clinically Relevant Specifications (CRS): A Regulatory Perspective Richard (Rik) Lostritto, Ph.D. Acting Deputy Director for Science & Policy and Acting Biopharmaceutics Lead, Office of New Drug Quality
More informationEuropean Guidance on Modified Release Dosage Forms
Safeguarding public health European Guidance on Modified Release Dosage Forms Terry Shepard, Pharmacokinetics Assessor Medicines and Healthcare products Regulatory Agency London PQRI Workshop on Application
More informationMechanistic IVIVC Using the Simcyp ADAM Model. Make SCIENCE out of IVIVC
Mechanistic IVIVC Using the Simcyp ADAM Model Make SCIENCE out of IVIVC %Dissolved in vivo % Dissolved/Absorbed %Dissolved/Absorbed Plasma Conc (ng/ml) IVIVC and Its Components IVIVC: A predictive mathematical
More informationGuideline on quality of oral modified release products
20 March 2014 EMA/CHMP/QWP/428693/2013 Committee for Medicinal Products for Human Use (CHMP) Final Draft Agreed by QWP May 2012 Adoption by CHMP for release for consultation 19 July 2012 Start of public
More informationIn Vitro-In Vivo Correlation:
In Vitro-In Vivo Correlation: Linking Drug Release to Clinical Performance Yihong Qiu, Ph.D. Abbott Laboratories 51st Land O' Lakes Conference: Bridging Material and Product Quality in Developing Tablet
More informationGuideline for Bioequivalence Studies of Generic Products. December 22, 1997
Guideline for Bioequivalence Studies of Generic Products December 22, 1997 Index Section 1: Introduction Section 2: Terminology Section 3: Tests A. Oral conventional dosage forms and enteric coated products
More informationHydrostatic Bearings for Machine Tools
Hydrostatic Bearings for Machine Tools Georg MÖRWALD, Jörg EDLER, Heinrich G. HOCHLEITNER Abstract: Hydrostatic bearings have advantages due to their simple design, wear-free performance and good damping
More informationUse of Mechanistic Population Based PBPK Models in the Establishment and Application of IVIVCs. Nikunjkumar Patel, Simcyp Limited
Use of Mechanistic Population Based PBPK Models in the Establishment and Application of IVIVCs Nikunjkumar Patel, Simcyp Limited IVIVC and Its Components CONVOLUTION VALIDATION DECONVOLUTION MODELS IVIVC
More informationGuideline on quality of oral modified release products
1 2 3 23 August 2012 EMA/492713/2012 Quality Working Party (QWP) 4 5 Draft Draft Agreed by QWP May 2012 Adoption by CHMP for release for consultation 19 July 2012 Start of public consultion 15 September
More informationInjectable modified release products
Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) Injectable modified release products Dr Sotiris Michaleas, National Expert for the
More informationApplication Strategy of PBPK for Generic Drugs and Its Current Challenges
BUILD A PHARMACEUTICAL COMPANY Application Strategy of PBPK for Generic Drugs and Its Current Challenges Bo Liu June 18, 2017 1 PuraCap Global Presence PuraCap Laboratories LLC, Kentucky PuraCap Pharmaceutical
More informationBiowaiver Approaches for Generic Drug Products in the US: Case Studies
About OMICS Group OMICS Group is an amalgamation of Open Access Publications and worldwide international science conferences and events. Established in the year 2007 with the sole aim of making the information
More informationIVIVC IMPORTANCE OF IVIVC AND METHODS OF ESTABLISHING IVIVC
IVIVC IMPORTANCE OF IVIVC AND METHODS OF ESTABLISHING IVIVC 1. INTRODUCTION The therapeutic efficacy of pharmaceutical formulations is governed by factors related to both the in vitro dissolution characteristics
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 informationDissolution Apparatus Types
Dissolution Apparatus Types Thank you for reading. As you may know, people have look numerous times for their favorite books like this, but end up in infectious downloads. Rather than enjoying a good book
More informationDissolution and clinically relevant specifications: linking clinical performance to dissolution
Dissolution and clinically relevant specifications: linking clinical performance to dissolution Talia Flanagan, Dave Holt, Paul Dickinson, Paul Stott. FDA/PQRI Conference on Evolving Product Quality 16-17
More informationPredictability & Performance Through the Product Lifecycle Thought Provoking Perspectives
Quality by Design & Clinical Relevance: Moving Forward Predictability & Performance Through the Product Lifecycle Thought Provoking Perspectives Roger Nosal 1 & Ravi Shanker 2 1 Vice President & Head Global
More informationCommon Deficiences in Bioequivalence Studies and Biowaiver Requests submitted to the JFDA
Common Deficiences in Bioequivalence Studies and Biowaiver Requests submitted to the JFDA DIMA S. SHAHIN, M.SC. MEMBER OF THE BIOEQUIVALENCE STUDIES TECHNICAL COMMITTEE REGISTRATION DEPARTMENT, DRUG DIRECTORATE-
More informationCOMMITTEE FOR VETERINARY MEDICINAL PRODUCTS GUIDELINES FOR THE CONDUCT OF BIOEQUIVALENCE STUDIES FOR VETERINARY MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology EMEA/CVMP/016/00-corr-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS GUIDELINES FOR THE CONDUCT
More informationBCS, Biowaivers and Dissolution Test Methodologies
BCS, Biowaivers and Dissolution Test Methodologies Vinod P. Shah, Ph.D., FAAPS, FFIP Pharmaceutical Consultant, (Formerly with US FDA) North Potomac, MD., USA Disso Europe 2016 Romania Advances and Applications
More informationConventional versus Physiologically-Based (PB)-IVIVC: Revisiting Some Successful and Failed Conventional IVIVC Cases with PB-IVIVC
Conventional versus Physiologically-Based (PB)-IVIVC: Revisiting Some Successful and Failed Conventional IVIVC Cases with PB-IVIVC Nikunj Patel, Senior Research Scientist Simcyp (a Certara Company) AAPS
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 informationModel based approaches to target special populations with rational formulation and clinical design strategies
Model based approaches to target special populations with rational formulation and clinical design strategies David Good 3 rd FDA/PQRI Conference on Advancing Product Quality Modeling for Oral and Non-Oral
More informationApproach, Information needed and criteria- suggested by the members of the IQ dissolution WG
Framework for setting Clinically relevant Dissolution Specification (CRS) Approach, Information needed and criteria- suggested by the members of the IQ dissolution WG Andreas Abend Merck Research Labs
More informationWho we are? Dissolution testing of modified release forms. Dissolution testing of immediate/ modified release forms
Dissolution testing of modified release forms Mumbai - 2013, May 3 Samir Haddouchi samir.haddouchi@sps-pharma.com 1 Dissolution testing of immediate/ modified release forms Mumbai - 2013, May 3 Samir Haddouchi
More informationKvantitativna analiza in R doc. dr. Franc Brcar
Kvantitativna analiza in R doc. dr. Franc Brcar Prirejeno po: Field, A., Miles, J., & Field, Z. (2012). Discovering Statistics Using R. London: SAGE. 1 Discovering Statistics Using R & SPSS 2 Program dela
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 informationDraft agreed by Pharmacokinetics Working Party February Adopted by CHMP for release for consultation 23 March 2017
18 October 2018 CPMP/EWP/239/95 Rev. 1 Committee for Medicinal Products for Human Use (CHMP) Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally
More informationNUMERICAL OPTIMIZATION OF THE METHOD OF COOLING OF A MASSIVE CASTING OF DUCTILE CAST-IRON
UDK 669.1:621.74 ISSN 1580-2949 Original scientific article/izvirni znanstveni ~lanek MTAEC9, 43(2)73(2009) NUMERICAL OPTIMIZATION OF THE METHOD OF COOLING OF A MASSIVE CASTING OF DUCTILE CAST-IRON NUMERI^NA
More informationOverview of comments received on 'guideline on quality of oral modified release products' (EMA/CHMP/QWP/428693/2013)
20 March 2014 EMA/CHMP/QWP/428694/2013 Committee for Human Medicinal Products (CHMP) Overview of comments received on 'guideline on quality of oral modified release products' (EMA/CHMP/QWP/428693/2013)
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 informationCase Study: Merck & Co., Inc.
Case Study: Merck & Co., Inc. Use of In Vivo Pharmacokinetic Data to Develop a CRS for In Vitro Dissolution Testing Barbara M. Davit Merck & Co., Inc. ( Merck ) UMD/FDA CERSI Workshop May 17, 2017 Implementing
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 informationQbD and Applied Biopharmaceutics for Patient Benefit
QbD and Applied Biopharmaceutics for Patient Benefit Arzu Selen, Ph.D. Associate Director, Biopharmaceutics Office of New Drug Quality Assessment/CDER/FDA The 32 nd Annual Midwest Biopharmaceutical Statistics
More informationRole of PBPK based virtual trials modeling in generic product development and regulation
Role of PBPK based virtual trials modeling in generic product development and regulation Robert Lionberger, Ph.D. Director Office of Research and Standards Office of Generic Drugs Center for Drug Evaluation
More informationIVIVC approach based on carbamazepine bioequivalence studies combination
Department of Pharmaceutics and Pharmaceutical Technology 1, University of Valencia; Department of Engineering 2, Area of Pharmaceutics and Pharmaceutical Technology, University Miguel Hernández, Elche;
More informationCourse Title PHARMACEUTICAL FORMULATION, DEVELOPMENT & BIOPHARMACEUTICS. Lecture : 05. Practical : 04. Course Credit. Tutorial : 00.
Course Title PHARMACEUTICAL FORMULATION, DEVELOPMENT & BIOPHARMACEUTICS Course Code CT113 Lecture : 05 Course Credit Practical : 04 Tutorial : 00 Total : 09 Course Objectives Upon completion of course
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 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 informationGuidance for Industry
Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products General Considerations DRAFT GUIDANCE This guidance document is being distributed for comment purposes
More informationCocrystals: A Regulatory Perspective. Scott L. Childs Renovo Research
Cocrystals: A Regulatory Perspective Scott L. Childs Renovo Research Outline FDA guidance EMA reflection paper Global regulatory strategies Potential for commercial impact Summary of FDA Guidance Cocrystals
More informationGuideline for the quality, safety and efficacy of follow-on biological medicinal products
Guideline for the quality, safety and efficacy of follow-on biological medicinal products 1. Introduction A follow-on biological medicinal product (hereinafter referred to as FOBMP) is considered as a
More informationFormulation Considerations for Over-Encapsulation of Clinical Trial Materials in DBcaps Capsules. Samantha Lai, Ph.D.
Formulation Considerations for Over-Encapsulation of Clinical Trial Materials in DBcaps Capsules Samantha Lai, Ph.D. BAS 251 E 2003 DBcaps capsules are often specified for over-encapsulation of active
More informationDissolution Testing. Development / Quality Control and in vivo Relevance. 31 May 1 June 2017 Copenhagen, Denmark HIGHLIGHTS:
Dissolution Testing Development / Quality Control and in vivo Relevance SPEAKERS DR THOMAS FÜRST Boehringer Ingelheim DR KERSTIN PAULI Bayer AG Image: ERWEKA GmbH, Germany DR ALEXANDER PONTIUS Bayer AG
More informationIn vivo predictive biopharmaceutics tools for oral drug delivery
In vivo predictive biopharmaceutics tools for oral drug delivery Bertil Abrahamsson, AstraZeneca and Mark McAllister, Pfizer Background non-absorbable drug complex complex formation drug in solid dosage
More informationEurofins ADME BIOANALYSES Your partner in drug development
Eurofins ADME BIOANALYSES Your partner in drug development Since 1987, you have placed your confidence in us. Our responsibility, to which my staff and I commit, is to consistently provide you with relevant
More informationBCS Guidance and Biowaivers BCS Monographs
BCS Guidance and Biowaivers BCS Monographs Vinod P. Shah, Ph.D., Pharmaceutical Consultant PQRI Board Member 2 nd FDA/PQRI Conference on Advancing Product Quality Emerging Regulatory Initiatives Biopharmaceutics
More informationDissolution Testing Development / Quality Control and in vivo Relevance
Dissolution Testing Development / Quality Control and in vivo Relevance SPEAKERS DR KERSTIN PAULI Bayer AG DR ALEXANDER PONTIUS Bayer AG Image: ERWEKA GmbH, Germany DR JOCHEN SCHER Boehringer Ingelheim
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 informationProfessor Andrea Laslop, MD, Austria
GaBI Scientific Meetings ROUNDTABLE ON BIOSIMILARS with participation by European Regulators and Medical Societies 12 January 2016, Sheraton Brussels Airport Hotel, Belgium Professor Andrea Laslop, MD,
More informationThe role and future of dissolution testing in a QBD product development framework
The role and future of dissolution testing in a QBD product development framework Paul Dickinson, AstraZeneca, Alderley Park, Cheshire Senior Clinical Pharmacology Scientist paul.dickinson@astrazeneca.com
More information"NOT FOR IMPLEMENTATION" GUIDANCE FOR INDUSTRY
"NOT FOR IMPLEMENTATION" GUIDANCE FOR INDUSTRY Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo
More informationUS FDAs Perspective on Product Quality and Bioequivalence
US FDAs Perspective on Product Quality and Bioequivalence Vinod P. Shah, Ph. D. Pharmaceutical Consultant (Formerly with US FDA) Scientific Principles in Dissolution Methodology and Drug Testing Society
More informationIn vitro - In vivo Correlation: From Theory to Applications
In vitro - In vivo Correlation: From Theory to Applications Jaber Emami Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran,
More informationRegulatory Requirements of Dissolution for Generic Drug Products
Regulatory Requirements of Dissolution for Generic Drug Products Om Anand, Ph.D. Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality - CDER, US-FDA International
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 informationPublic Assessment Report. Scientific discussion. Perindopril arginine Actavis (perindopril arginine) SE/H/1456/01-03/DC
Public Assessment Report Scientific discussion Perindopril arginine Actavis (perindopril arginine) SE/H/1456/01-03/DC This module reflects the scientific discussion for the approval of Perindopril arginine
More informationManufacturing Technology Committee Risk Management Working Group Risk Management Case Studies. Case No. RMWG-07. Space
Manufacturing Technology Committee Risk Management Working Group Risk Management Case Studies Case Study Title: Defining Process Design Space Case No. RMWG-07 GMP System Impacted: Introduction / Background
More informationLine extension of immediate release products
EMA/EGA Joint Workshop on the Impact of the Revised EMA Guideline on Modified Release Dosage Forms Line extension of immediate release products London, 30 th April 2014 Dr. Alfredo García Arieta Jefe de
More informationIn silico tools to study food-drug interactions, an Industry Perspective
Paris, April 4th, 2018 Physiologically Based PharmacoKinetic modeling (PBPK): A new Paradigm in Drug Development In silico tools to study food-drug interactions, an Industry Perspective Neil Parrott, Pharmaceutical
More informationAnalysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products
Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products Paramjeet Kaur, Xiaojian Jiang, and Ethan Stier Division of Bioequivalence
More informationPharmacokinetic and pharmacodynamic evaluation of a new vascular calcification inhibitor (INS-3001) in rats
Pharmacokinetic and pharmacodynamic evaluation of a new vascular calcification inhibitor (INS-3001) in rats M. Maillard 1, D. Mordasini,D 1. Spaggiari 2, O. Phan 1, M. Ivarsson 3, R. Maj 3, L.A. Décosterd
More informationINSIGHT-DRIVEN FORMULATIONS DEVELOPMENT
INSIGHT-DRIVEN FORMULATIONS DEVELOPMENT HOW AN INTEGRATED DEVELOPMENT PLATFORM CAN PROVIDE END-TO-END VISIBILITY ACROSS PRE-FORMULATIONS AND FORMULATIONS DEVELOPMENT 1 A considerable amount and variety
More informationThe use of surrogates for dissolution testing for Immediate Release (IR) formulations, when is it feasible?
The use of surrogates for dissolution testing for Immediate Release (IR) formulations, when is it feasible? Limin Zhang (Bristol-Myers Squibb Company) Andre Hermans (Merck & Co., Inc.) 2017 M-CERSI Workshop
More informationEffect of Hydrophobic Polymers on the Gastro Retention Time and In vitro Release of Ciprofloxacin HCl from Co-matrix Tablets
Effect of Hydrophobic Polymers on the Gastro Retention Time and In vitro Release of Ciprofloxacin HCl from Co-matrix Tablets Muhammad Shahidul Islam 1, Kumar Bishwajit Sutradhar 2, Jakir Ahmed Chowdhury
More informationHow Research Can Help Us Rethink Lifecycle Management and Post- Approval Changes: Oral Products
How Research Can Help Us Rethink Lifecycle Management and Post- Approval Changes: Oral Products James E. Polli jpolli@rx.umaryland.edu September 17, 2014 Perspective The societal promotion of generic products
More informationBiowaivers: BCS and IVIVC
Workshop in Celebration of 25 th Anniversary of the School of Pharmacy School of Pharmacy Faculty of Medicine The Chinese University of Hong Kong Biopharmaceutics of Modified Release Products and Challenging
More informationIN-VITRO AND IN-VIVO RELATIONSHIP AND INFLUENCE OF COVARIATES ON PHARMACOKINETICS OF URAPIDIL SUSTAINED RELEASE CAPSULES
Academic Sciences International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 6, Suppl 1, 014 IN-VITRO AND IN-VIVO RELATIONSHIP AND INFLUENCE OF COVARIATES ON PHARMACOKINETICS OF
More informationEffect of Various Sustained Release Polymers on Naproxen Sodium Release from Control Release Tablets
International Journal of Pharmacy Teaching & Practices 3, Vol.4, Issue, 636-643. Effect of Various Sustained Polymers on Sodium from Control Tablets Md. Shamim Akhter *, Md. Amir Hossain, Emran Hossain
More informationMalleswari et.al Indian Journal of Research in Pharmacy and Biotechnology ISSN: (Print) ISSN: (Online)
Comparative in-vitro dissolution study of five brands of Diclofenac sodium delayed release tablets in QbD environment V Malleswari Bai* 1, M Prasada Rao 1, M Chandana 1, K Naga Harini 1, B Naga Deepthi
More informationTHE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION
THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION Pharmacopeial Forum Vol. 31(5)(Sept.-Oct. 2005) By : Mr. Seubpong Kumpusiri Mrs. Patima Maneesatid 26 May 2006 THE DISSOLUTION PROCEDURE: DEVELOPMENT
More informationThe release of the drug substance from a solid dosage
dx.doi.org/10.14227/dt210314p11 History and Evolution of the Dissolution Test Patrick J. Marroum Marroum Pharmaceutical Consulting, 9114 Blarney Stone Dr., Springield, VA 22152 e-mail: Marroum@prodigy.net
More informationSUPPLEMENTARY INFORMATION
In format provided by Orchard et al. (SEPTEMBER 2011) Supplementary information S1 Sample MIABE file exemplifying data extracted from PMID: 20568778 Responsible Person or Role Contact Person Bryan K. S.
More informationAbstract. Technical Aspects. Applying GastroPlus for Extensions of Biowaivers for BCS Class II Compounds 2
Abstract GastroPlus is a mechanistically based simulation software package that predicts absorption, pharmacokinetics, and pharmacodynamics in humans and animals. GastroPlus modeling and simulation has
More informationThe folowing four Rules-Of-Thumb summarize the more important aspects of electronic absorption:
The folowing four Rules-Of-Thumb summarize the more important aspects of electronic absorption: 1. The amount of energy absorbed by an electron equals the quanta of energy of the photon absorbed. 2. Ground
More informationUnit V APPLICATIONS OF PHARMACOKINETICS
Unit V APPLICATIONS OF PHARMACOKINETICS Presented by Mrs M. Sabareesh M.Pharm., Associate Professor Department of Pharmaceutics Krishna Teja Pharmacy college Subject; ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS(17SO3202)
More informationDevelopment of Quality Control Method for Dissolution Analysis of Tapentadol and paracetamolin tablet
Original Research Article Development of Quality Control Method for Dissolution Analysis of Tapentadol and paracetamolin tablet Krishna R Gupta 1,*, Kiran N. Kale 2 1 Professor, 2 Phd. Scholar, SKB College
More informationBiopharmaceutics Applications in Drug Development
Biopharmaceutics Applications in Drug Development Edited by Rajesh Krishna Merck & Co., Inc. Rahwav, NJ. USA and Lawrence Yu Center for Drug Evaluation & Research Rockville, MD, USA 4y Springer Contents
More informationA Novel Comparative Evaluation for the Quality of Oral Generic Drugs
Regular Article Jpn. J. Pharm. Health Care Sci. 39(3) 156 165 (2013) A Novel Comparative Evaluation for the Quality of Oral Generic Drugs Masato Terashita, Kazuhiro Iguchi, Shigeyuki Usui and Kazuyuki
More informationIn vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria
J Vector Borne Dis 45, March 2008, pp. 60 65 In vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria C.O. Esimone a, F.B.C. Okoye b, B.U. Onah a, C.S. Nworu c & E.O. Omeje
More informationComparative analysis of eight brands of sulfadoxinepyrimethamine
Tropical Journal of Pharmaceutical Research, June 2003; 2 (1): 161-167 Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria. All rights reserved. Available online at http://www.tjpr.freehosting.net
More informationThe development of novel dissolution approaches
dx.doi.org/1.14227/dt22315p18 Development of a Glass-Bead Device for Dissolution Testing Marija Bogataj *, Greta Cof, and Aleš Mrhar Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, Ljubljana,
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 informationPresentation Outline. Introduction Sources of Challenge for BE study
Presentation Outline Introduction Sources of Challenge for BE study Necessity of a BE Study? Study Design CRO Ethics Committee Regulatory Authority Sponsor (Personnel or Product) 1st MENA Regulatory Conference
More informationIMPROVING THE CORROSION RESISTANCE OF COMPONENTS MADE FROM STRUCTURAL STEELS
UDK 669.14.18.298:62.193 ISSN 158-2949 Original scientific paper/izvirni znanstveni ~lanek MTAEC9 4(1)17(6) IMPROVING THE CORROSION RESISTANCE OF COMPONENTS MADE FROM STRUCTURAL STEELS POVE^ANJE KOROZIJSKE
More informationCarbon footprint. Špela Kern Umanotera, Slovenska fundacija za trajnostni razvoj E-pošta:
Carbon footprint Špela Kern Umanotera, Slovenska fundacija za trajnostni razvoj E-pošta: [spela@umanotera.org] Abstract: Climate change is increasingly recognised as a major challenge. It is widely accepted
More informationDEVELOPMENT OF ALUMINIUM ALLOYS FOR AEROSOL CANS
UDK 620.1:669.715:621.3.035.15 ISSN 1580-2949 Original scientific article/izvirni znanstveni ~lanek MTAEC9, 50(4)601(2016) J. TURK ET AL.: DEVELOPMENT OF ALUMINIUM ALLOYS FOR AEROSOL CANS 601 605 DEVELOPMENT
More informationVarnost nanomaterialov: povezava med njihovimi lastnostmi in učinki na okolje
Varnost nanomaterialov: povezava med njihovimi lastnostmi in učinki na okolje Anita Jemec, Damjana Drobne Skupina za Nanobiologijo in Nanotoksikologijo, Biotehniška fakulteta, Oddelek za biologijo. www.bionanoteam.com
More informationStability studies of the optimized oral metoclopramide hydrochloride tablet formulations prepared for IVIVC studies
World Journal of Pharmaceutical Sciences ISSN (Print): 2321-3310; ISSN (Online): 2321-3086 Published by Atom and Cell Publishers All Rights Reserved Available online at: http://www.wjpsonline.org/ Original
More informationKING KHALID UNIVERSITY COLLEGE OF PHARMACY DEPARTMENT OF PHARMACEUTICS COURSE SPECIFICTION FOR PHARMACEUTICAL SCIENCES/PHARM-D
KING KHALID UNIVERSITY COLLEGE OF PHARMACY DEPARTMENT OF PHARMACEUTICS COURSE SPECIFICTION FOR PHARMACEUTICAL SCIENCES/PHARM-D BY Mohammed Mahmoud Academic Session 147-8 1 st Semester (Semester No 71)
More informationWe embrace research and science, providing innovative products and integrated services to improve people s quality of life.
Services Book 2016 Our DNA Philosophy We embrace research and science, providing innovative products and integrated services to improve people s quality of life. Vision We aspire to be one of the best
More informationRegulatory Assessment
Implementation of ICH Q8, Q9, Q10 Regulatory Assessment International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Presentation Overview Goal
More informationTHERMOMECHANICAL PROCESSING OF MICRO-ALLOYED STEEL
UDK 621.73:519.876.5 ISSN 1580-2949 Original scientific article/izvirni znanstveni ~lanek MTAEC9, 48(6)855(2014) P. PODANY, P. MARTINEK: THERMOMECHANICAL PROCESSING OF MICRO-ALLOYED STEEL THERMOMECHANICAL
More informationSCIENTIFIC DISCUSSION
SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredients (APIs): Pharmaco-therapeutic group (ATC Code): Therapeutic indication:
More informationDissolution Methodologies from Biorelevant to Quality Control The Challenges and Gaps
Dissolution Methodologies from Biorelevant to Quality Control The Challenges and Gaps Xujin Lu 1, Jian-Hwa Han 2, Danna Mattocks 3 1 Analytical Science, DPST, Bristol-Myers Squibb Company 2 NCE-Analytical
More informationEFFECT OF TEMPERING ON THE ROOM-TEMPERATURE MECHANICAL PROPERTIES OF X20CrMoV121 AND P91 STEELS
UDK 669.14.018.44:621.785.72:620.17 ISSN 1580-2949 Original scientific article/izvirni znanstveni ~lanek MTAEC9, 46(5)459(2012) F. KAFEXHIU et al.: EFFECT OF TEMPERING ON THE ROOM-TEMPERATURE MECHANICAL
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 informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL DISSOLUTION This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control
More informationPreclinical Development Discovery to IND
Preclinical Development Discovery to IND Biobootcamp CBSA / Fitzsimons / FBBp / Holland & Hart Lauren C. Costantini, Ph.D. www.lccconsulting.net This Discussion Research and Development Product development
More information