<1151> Pharmaceutical Dosage Forms and <1152> Animal Drugs for Use in Animal Feeds
|
|
|
- Barry Brown
- 6 years ago
- Views:
Transcription
1 <1151> Pharmaceutical Dosage Forms and <1152> Animal Drugs for Use in Animal Feeds Will Brown Veterinary Drugs Stakeholder Forum February 19-20, 2014
2 Development of a Compendial Taxonomy and Glossary for Pharmaceutical Dosage Forms, PF 29(5) [Sept, 2003], K Marshall, TS Foster, HS Carlin, RL Williams Organized in three tiers Route of administration, Dosage form USP Dosage Forms Taxonomy Grouped as solid, liquid, gas, or aerosol with specific form (e.g., tablet, cream, insert) as subordinate categories Type of release: immediate or modified 2
3 <1151> Pharmaceutical Dosage Forms General Information Chapter Longstanding chapter recently revised, USP 35 official May 1, 2012 High level information on dosage forms Organized on basis of physical form Route of administration addressed in Chapters <1> to <5> 3
4 <1151> Organization General Considerations General Product Quality Tests Dosage Forms Glossary 4
5 <1151> General Considerations Dose Uniformity Stability Bioavailability Manufacture Route of Administration Packaging and Storage Labeling 5
6 <1151> General Product Quality Tests Follows ICH Q6A Description (Definition) Identification Assay Impurities Sterility Bacterial endotoxins etc 6
7 <1151> Dosage Forms Aerosols Injections Powders Capsules Inserts Soaps/Shampoos Creams Irrigations Solutions Emulsions Liquids Sprays Films Lotions Strips Foams Lozenges Suppositories Gases Ointments Suspensions Gels Pastes Systems Granules Pellets Tablets Gums Pills Tapes* Implants Plasters 7
8 Glossary Dosage Forms: A combination of drug substance(s) and/or excipient(s) in quantities and physical form designed to allow the accurate and efficient administration of the drug substance to the human or animal patient Related Terminology Release pattern Immediate, Extended, Delayed Preferred terminology indicated for entries that represent not preferred terminology 8
9 <1152> Animal Drugs for Use in Animal Feeds Premixes not preferred although a legacy term (e.g., Monensin, Narasin, and Decoquinate) Not dosage forms by the definition in <1151> Particularly so for drugs given free choice New general information chapter proposed, PF 40(1) January
10 Chapter content at a glance General descriptions and definitions General principals of preparation Labeling and packaging Nomenclature 10
11 Nomenclature Type A medicated article Type A liquid medicated article Type B medicated feed Type B liquid medicated feed Type C medicated feed Type C liquid medicated feed Type C free-choice medicated feed Type C liquid free-choice medicated feed Type C top-dress medicated feed 11
12 Some requests <1151> addresses dosage forms. Content is intended to apply to animal as well as human dosage forms. The chapter is expected to undergo continuous revision. Please forward any suggestions to me. Comment period for PF 40(1) ends March 31 12
13 <1> Injections and Implanted Drug Products (Parenterals) - Product Quality Tests
14 General Chapters for Administration Routes Route of administration....(liaison) 1. Injectable / Parenteral (Desmond Hunt) 2. Oral.. (Antonio Hernandez-Cardoso) 3. Skin surface (Topical, Transdermal).. (Margareth Marques) 4. Mucosal....(Will Brown) 5. Lungs, Inhalation (aerosols)....(kahkashan Zaidi) Team lead: Vinod Shah, USP consultant 14
15 <1> Injections Original title of a longstanding chapter Title change Content revised to fit into approach taken for the five route chapters Some content moving to other general chapters 15
16 Revised Content Universal product quality tests Derived from ICH Q6A Tests for specific parenteral dosage forms Solutions Emulsions Sterile powders for injection Liposomes Suspensions In situ gels Microparticles Implants Stents and Drug Eluting Stents 16
17 Relocated Content To <7> Labeling Labels and Labeling Potassium Chloride for Injections Concentrate Neuromuscular Blocking and Paralyzing Agents To <659> Packaging and Storage Requirements Containers for Injections Containers for Sterile Solids Packaging and Storage To a new chapter, <697> Container Content for Injections Container Content All chapters, <1>, <7>, <659>, and <697> will move to official status at the same time. 17
18 USP Packaging Standards 18
19 Chapter list (Official USP 37) <659> Packaging and Storage Requirements <660> Containers Glass <1660> Evaluation of Inner Surface Durability of Glass Containers <661> Plastic Packaging Systems and Their Materials of Construction <661.1> Plastic Materials of Construction 19
20 Chapter List New in PF 39(5) [Sept 2013] <661.1> Plastic Materials of Construction <661.2> Plastic Packaging Systems for Pharmaceutical Use <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems <1664.1> Orally Inhaled and Nasal Drug Products 20
21
22
905 UNIFORMITY OF DOSAGE UNITS
Change to read: 905 UNIFORMITY OF DOSAGE UNITS [ NOTE In this chapter, unit and dosage unit are synonymous. ] To ensure the consistency of dosage units, each unit in a batch should have a drug substance
Principals and dosage forms of pharmaceutics
Principals and dosage forms of pharmaceutics Part II. Semisolid dosage forms: ointments, creams, gels, pastes, suppositories, pessaries 2017 Dr. Farkas, Gyula Pharmaceutical Propedeutics Institute of Pharmaceutical
Medication Administration. By: Carolyn McCune RN, BSN, MSN, CRNP
Medication Administration By: Carolyn McCune RN, BSN, MSN, CRNP Percutaneous Administration Medications application to the skin or mucus membranes Ointments, creams, powders, lotions, solutions into the
Disclosure. Objectives. Objectives. Introduction. Introduction. Non-Sterile Compounding/Calculations
49th Annual Meeting Non-Sterile Compounding/ Sunil Jambhekar, B. Pharm., M.S., Ph.D Professor, Pharmaceutical Sciences LECOM Bradenton, School of Pharmacy Bradenton, FL 34211 Disclosure I do not have a
PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION
PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION 1 PHARMACEUTICS Pharmaceutics is the science of dosage form design. The general area of study concerned with the formulation, manufacture, stability, and
Nomenclature Guidelines
Nomenclature Guidelines This document is referenced in USP General Chapter Nomenclature, and will be periodically updated by the USP Expert Committee on Nomenclature, Safety and Labeling (last revision
Nomenclature Guidelines
This document is referenced in USP General Chapter Nomenclature, and will be periodically updated by the USP Expert Committee on Nomenclature, Safety and Labeling Introduction A consistent and logical
INFORMATION TOPIC: II-5 OR DEMONSTRATION: II-5. DOSAGE, MEASUREMENTS, AND DRUG FORMS (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO:
LESSON PLAN: 5 COURSE TITLE: UNIT: II MEDICATION TECHNICIAN GENERAL PRINCIPLES SCOPE OF UNIT: This unit includes medication terminology, dosage, measurements, drug forms, transcribing physician s orders,
Principals and Dosage Forms in the Therapy Modified Drug Release. Institute of Pharmaceutical Technology and Biopharmacy
Principals and Dosage Forms in the Therapy Modified Drug Release Institute of Pharmaceutical Technology and Biopharmacy Dosage forms Definition: Dosage forms are the means by which drug molecules are delivered
EUROPEAN COMMISSION DIRECTORATE-GENERAL III INDUSTRY Industrial affairs III: Consumer goods industries Pharmaceuticals and Cosmetics
EUROPEAN COMMISSION DIRECTORATE-GENERAL III INDUSTRY Industrial affairs III: Consumer goods industries Pharmaceuticals and Cosmetics Community Basic Format for Manufacturing Authorisation Explanatory Notes
INFORMATION TOPIC: II-5 OR DEMONSTRATION: II-5. DOSAGE, MEASUREMENTS, AND DRUG FORMS (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO:
LESSON PLAN: 5 COURSE TITLE: UNIT: II MEDICATION TECHNICIAN GENERAL PRINCIPLES SCOPE OF UNIT: This unit includes medication terminology, dosage, measurements, drug forms, transcribing physician s orders,
USP NF General Chapter <905> Uniformity of Dosage Units
USP NF General Chapter Uniformity of Dosage Units Type of Posting: Explanatory Note Posting Date: 20 Apr 2007 This explanatory note is intended to clarify the steps taken by USP to address issues
EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use
EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Brussels, March 2018 SANTE-2017-11668 Revision 2 NOTICE TO APPLICANTS VOLUME 2C Guidelines Medicinal products for human use Safety, environment
GUIDELINE ON THE CATEGORISATION OF EXTENSION APPLICATIONS (EA) versus VARIATIONS APPLICATIONS (V) OCTOBER 2003
EUROPN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, implementation and legislation for consumer goods Pharmaceuticals : regulary framework and market authorisations Brussels, F2/AW D(2002)
COMMENTS. Submitted by The International Pharmaceutical Aerosol Consortium
COMMENTS on a draft Guidance for Industry Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing, and Controls Documentation (Docket No. 99D-1454) Submitted by
Introduction to. Pharmacokinetics. University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D
Introduction to 1 Pharmacokinetics University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D 2 Learning objectives Understand compartment models and how they effects
Parenteral Products. By: Howida Kamal, Ph.D
Parenteral Products By: Howida Kamal, Ph.D Dosage forms Route of administration Enteral INTO Parenteral ONTO Topical Dosage forms Physical form Solid Liquid Semi-solid Powder Granules Tablets Capsules
T Pharmaceutics-I (Dispensing Pharmacy)
T.1.1.1. Pharmaceutics-I (Dispensing Pharmacy) Dosage Forms 1. Define Dosage Forms. Give classification. 2. Define: Creams, Pastes, Gargles, Elixirs, 3. Give Classification of dosage form. Prescription
Assessment of Human Pharmaceutical Products Registered in Kenya by Route of Administration and Type of Dosage Form
38 East and Central African Journal of Pharmaceutical Sciences Vol. 15 (2012) 38-46 Assessment of Human Pharmaceutical Products Registered in Kenya by Route of Administration and Type of Dosage Form N.N.
BRIEFING. Nonharmonized attributes: Identification, Heavy metals, Characters, Labeling, Bacterial endotoxins, Sterility, Storage.
BRIEFING Citric Acid, Anhydrous, page 872 of PF 28(3) [May June 2002]. The European Pharmacopoeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for the
Compendial Approvals for USP 34-NF 29, Second Supplement
Compendial Approvals for USP 34-NF 29, Second Supplement Monograph Title Monograph Section Scientific Liaison IMPURITIES TESTING IN MEDICAL GASES PF 35(4) Pg. 920 MEDICAL GASES ASSAY PF 35(4)
WITH APPLICATIONS TO : ; : GENERAL AND SPECIALTY AREAS
f Fourth Edition WITH APPLICATIONS TO : ; : GENERAL AND SPECIALTY AREAS Joyce LeFever Kee, RN, MS Associate Professor Emerita College of Health and Nursing Sciences University of Delaware Newark, Delaware
The Therapeutic Goods Act (1989)
EDUCATION PRACTICE UPDATE Assigning expiry dates to compounded medications First published in the Australian Journal of Pharmacy, Vol. 99, No.1169, February 2018, pp.72-76. Reproduced and distributed by
Organic Impurities in Drug Substances and Drug Products. Antonio Hernandez-Cardoso, M.Sc. Senior Scientific Liaison September 8, 2017
Organic Impurities in Drug Substances and Drug Products Antonio Hernandez-Cardoso, M.Sc. Senior Scientific Liaison September 8, 2017 Potential sources of drug impurities during development AAPS PharmSciTech,
The USP and Compounding Nonsterile Medications
November 21, 2015 Association of Portuguese Hospital Pharmacists The USP and Compounding Nonsterile Medications Lisa D. Ashworth, BS Pharm, RPh, FACA Compounding Specialist and Clinical Pharmacist, Children
UNIT 2 SOLID AND LIQUID DOSAGE FORMS
UNIT 2 SOLID AND LIQUID DOSAGE FORMS Solid and Liquid Structure 2.1 Introduction Objectives 2.2 Solid Tablets Capsules 2.3 Liquid Advantages of Liquid Disadvantages of Liquid Classification of Liquid Monophasic
EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use
EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Brussels, Draft Revision 2 NOTICE TO APPLICANTS VOLUME 2C Guidelines Medicinal products for human use Safety, environment and information
Pharmaceutical Preparation For Internal Use
Pharmaceutical Preparation For Internal Use 1. Solid Preparations (Tablet, Capsule, Pill) 2. Liquid Preparations (Aqua, Syrup, Elixir, Extract, Liquor, Emulsion, Mixture, Infusion, Decoction). 3. Powder
USP Chewable Gels Monographs
USP Dietary Supplements Stakeholder Forum Tuesday, May 15, 2018 USP Chewable Gels Monographs Natalia Davydova, Ph.D. Scientific Liaison DS Gummies Market Value of the gummy vitamins market in the United
Division 1 Introduction to Advanced Prehospital Care
Division 1 Introduction to Advanced Prehospital Care Chapter 7 Intravenous Access and Medication Administration Part 1 Principles and Routes of Medication Administration Topics Aseptic Technique Medication
The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities
Prescription/Non-Prescription Stakeholder Forum Thursday, October 18, 2018 The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities Galina Holloway, Ph.D. Senior Scientific
1 INJECTIONS INTRODUCTION
1 INJECTIONS INTRODUCTION Parenteral articles are preparations intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal, so that the active substances
CHAPTER-I DRUG CHARACTERIZATION & DOSAGE FORMS
CHAPTER-I DRUG CHARACTERIZATION & DOSAGE FORMS by: j. jayasutha lecturer department of pharmacy practice Srm college of pharmacy srm university DRUG CHARACTERIZATION: Pre-formulation studies will attempt
NANO 243/CENG 207 Course Use Only
L6. Drug Administration & Transport by Fluid Motion April 19, 2018 Part I: Drug Administration Routes of Drug Administration Topical: local effect, substance is applied directly where its action is desired.
Revisions to USP 31 NF 26, Second Supplement
Revisions to USP 31 NF 26, Second Supplement (published May 2008) Published April 2008 General Chapters Monographs:A C D N O S T Z Monograph Section Head Scientific Liaison DANTROLENE SODIUM CAPSULES PF
232 ELEMENTAL IMPURITIES LIMITS
BRIEFING 232 Elemental Impurities Limits, USP 39 page 268. This chapter is being revised to address comments received and to further align this chapter with ICH Q3D. USP s Elemental Impurities Expert Panel
Quality of medicines in Portugal: a retrospective review of medicine recalls ( ) Ana Teresa Reis Bruna Berardo Rui Loureiro
Quality of medicines in Portugal: a retrospective review of medicine recalls (2005-2015) Ana Teresa Reis Bruna Berardo Rui Loureiro Introduction Human medicines Cosmetics Veterinary medicines Medical devices
PHAR 7632 Chapter 7. Table Market and Share of Pharmaceuticals by ROA Data from Viswanathan, 2004
Student Objectives for this Chapter After completing the material in this chapter each student should:- be able to describe various routes of drug administration including the concentration versus time
General Chapter/Section: <232> Elemental Impurities - Limits Expert Committee(s): General Chapters Chemical Analysis No.
General Chapter/Section: Elemental Impurities - Limits Expert Committee(s): General Chapters Chemical Analysis No. of Commenters: 18 Editorial changes suggested by commenters have been reviewed by
PERCENTAGE and RATIO STRENGTH
University of Kerbala College of Pharmacy Department of Pharmaceutics Principles of Pharmacy Practice Lecture 3 PERCENTAGE and RATIO STRENGTH Assistant lecturer Zahraa Alaa Hasan MSc. Drug Delivery 2018-2019
FILL AMOUNT CONTROL FOR LIQUID AND SEMISOLID DOSAGE FORMS
How to Facilitate First Cycle Approvals Recommendations and Expectations FILL AMOUNT CONTROL FOR LIQUID AND SEMISOLID DOSAGE FORMS Yaodong (Tony) Huang, Ph.D. Quality Assessment Lead (Acting) Branch VIII/Division
6. SR, XR, CR, and TR are examples of formulations. A) oral B) modified release C) repeat action D) soft gels
1. Which is a parenteral route of administration? A) oral B) vaginal C) sublingual D) rectal 2. A local effect occurs A) at the site of administration. B) throughout the body. C) only after intravenous
Completion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation
Completion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation Workshop on Paediatric Formulations For Assessors in National Regulatory Agencies
General concepts in the Ph. Eur.: theory and rationale
General concepts in the Ph. Eur.: theory and rationale Cathie VIELLE Head of European Pharmacopoeia Department, EDQM / CoE 1 The structure of the Ph. Eur. General monographs Dosage form monographs General
UNIT I EVOLUTION OF THE PHARMACY
Contents UNIT I EVOLUTION OF THE PHARMACY........................ 1 Chapter 1 Pharmacy History................................................. 3 Egyptian History 4 Greek Influence 4 British Apothecaries
Chapter 7. Principles of Pharmacology
Chapter 7 Principles of Pharmacology Introduction Administering medications is a serious business. Medications may alleviate pain and improve patient s well-being. Used inappropriately, may cause harm
» Monohydrate Citric Acid contains one molecule of water of hydration. It contains not less than 99.5 percent and not more than 100.
BRIEFING Citric Acid, Monohydrate. The European Pharmacopoeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for the Citric Acid, Monohydrate monograph,
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PHARMACEUTICAL QUALITY OF INHALATION AND NASAL PRODUCTS
European Medicines Agency Inspections London, 16 February 2005 Doc Ref.: EMEA/CHMP/QWP/49313/2005 corr. COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PHARMACEUTICAL QUALITY OF
BRIEFING 1 INJECTIONS INTRODUCTION
BRIEFING 1 Injections, USP 28 page 2201. The United States Pharmacopeia is the coordinating pharmacopeia in the efforts toward international harmonization of the specifications provided in this general
Routes of drug administration
Routes of drug administration Definition:- A route of administration in pharmacy is the path by which a drug is taken into the body. Classification:- The various routes of administrations are classified
For External Use Only. Should neither be swallowed. Nor injected
For External Use Only Should neither be swallowed Nor injected Preparations which are applied to the skin. (Topical preparations) Preparations which are applied to the mucus membranes. Local effect Systemic
REVISION OF MONOGRAPH ON TABLETS. Tablets
March 2011 REVISION OF MONOGRAPH ON TABLETS Final text for addition to The International Pharmacopoeia This monograph was adopted by the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical
IMDG CODE Poison Treatment Chest
2017 IMDG CODE Poison Treatment Chest This document contains the complete list of medicines and medical supplies for the vessels poison treatment chest and is based on the IMDG code international maritime
DRAFT PROPOSAL FOR REVISION OF GENERAL MONOGRAPHS: PARENTERAL PREPARATIONS. (July 2012) Draft for comment
1 2 3 4 5 DRAFT PROPOSAL FOR REVISION OF July 2012 RESTRICTED GENERAL MONOGRAPHS: PARENTERAL PREPARATIONS (July 2012) Draft for comment This document was provided by a quality control expert. Should you
University of Sulaimani School of Pharmacy Dept. of Pharmaceutics Third level - Second semester
University of Sulaimani School of Pharmacy Dept. of Pharmaceutics Third level - Second semester 5/21/2017 Pharmaceutical Compounding, Dr. rer. nat. Rebaz Ali 1 Outlines Why rectal or vaginal route? Suppository
1 INJECTIONS INTRODUCTION
1 INJECTIONS INTRODUCTION Parenteral articles are preparations intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal, so that the active substances
COMMENTARY TO USP31 - NF26
Revision proposals published in Pharmacopeial Forum often elicit public comments that are forwarded to the appropriate Expert Committee for review and response. In accordance with the Rules and Procedures
TANZANIA FOOD AND DRUGS AUTHORITY
Doc. No. TFDA/DMC/HVR/G/001 TANZANIA FOOD AND DRUGS AUTHORITY GUIDELINES ON LIST OF STANDARD TERMS FOR PHARMACEUTICAL DOSAGE FORMS AND ROUTES OF ADMINISTRATION (Made under Section 52 (1) of the Tanzania
TANZANIA FOOD AND DRUGS AUTHORITY
Doc. No. TFDA/DMC/MCER/---- TANZANIA FOOD AND DRUGS AUTHORITY GUIDELINES ON LIST OF STANDARD TERMS FOR PHARMACEUTICAL DOSAGE FORMS AND ROUTES OF ADMINISTRATION (Made under Section 52 (1) of the Tanzania
Current FDA Perspective on Excipients NJPhAST Meeting September 15, 2016
Current FDA Perspective on Excipients NJPhAST Meeting September 15, 2016 Jeffrey B. Medwid, Ph.D., Office of New Drugs, API Branch II Senior CMC Reviewer OPQ/CDER/FDA Jeffrey.Medwid@FDA.HHS.ov My presentation
6/7/2017 CHANGES IN PHARMA REGULATIONS HOW IT AFFECTS THE OR NURSE DISCLOSURE OBJECTIVES
CHANGES IN PHARMA REGULATIONS HOW IT AFFECTS THE OR NURSE John Karwoski, RPh, MBA DISCLOSURE I, John Karwoski, RPH, MBA have business relationships with the companies MOBIUS THERAPEUTICS, LLC, Cubex, and
PREMIXES FOR MEDICATED FEEDING STUFFS FOR VETERINARY USE. Praeadmixta ad alimenta medicata ad usum veterinarium. Effervescent powders
Preparations for inhalation administered in or with water or another suitable liquid. They may also be swallowed directly. They are presented as single-dose or multidose preparations. Where applicable,
Overview of USP General Chapters <476> and <1086> Prescription/Non-Prescription Stakeholder Forum October 19, 2017
Overview of USP General Chapters and Prescription/Non-Prescription Stakeholder Forum October 19, 2017 Introduction Periodic review of existing general chapters Typically an approximately 5
Long-Term Care Updates
Long-Term Care Updates May 2016 By Katee Miller, PharmD Candidate, Mohamed Jalloh, PharmD, & Zara Risoldi Cochrane, PharmD, MS, FASCP Introduction Enteral nutrition (EN) through a tube is the preferred
Drug Development by Government Pharmaceutical Organization. Dr. Rachaneekorn Jevprasesphant The Government Pharmaceutical Organization (GPO) Thailand
Drug Development by Government Pharmaceutical Organization Dr. Rachaneekorn Jevprasesphant The Government Pharmaceutical Organization (GPO) Thailand 20August 2012 GPO s Profile GPO was established in 1966.
CONTROLLED-RELEASE & SUSTAINED-RELEASE DOSAGE FORMS. Pharmaceutical Manufacturing-4
CONTROLLED-RELEASE & SUSTAINED-RELEASE DOSAGE FORMS Pharmaceutical Manufacturing-4 The improvement in drug therapy is a consequence of not only the development of new chemical entities but also the combination
USP <232> and <233> Understanding Your Path to Compliance with the New Elemental Impurity Chapters. Steve Wall Agilent Technologies
USP and Understanding Your Path to Compliance with the New Elemental Impurity Chapters Steve Wall Agilent Technologies Outline, USP - USP Chapter - Chapter Limits -
AAM Fall Tech Conference November 6-8, 2017 Rockville, MD
AAM Fall Tech Conference 2017 November 6-8, 2017 Rockville, MD Excipients Breakout Session Highlights of FDA-USP workshop on Critical Importance of Excipients in Drug Development Why Excipients are Important
FDB FOOD AND DRUGS BOARD G H A N A GUIDELINES FOR CONDUCTING BIOEQUIVALENCE STUDIES
FDB FOOD AND DRUGS BOARD G H A N A GUIDELINES FOR CONDUCTING BIOEQUIVALENCE STUDIES 1 SCOPE In pursuance of section 47 of the Food and Drugs Law 1992, P.N.D.C.L 305B, as amended by Act 523, 1996, these
TYPES OF DISPENSED PREPARATIONS
TYPES OF DISPENSED PREPARATIONS Dr. Dhaivat C. Parikh Institute of Pharmacy, Nirma University DISCLAIMER This Presentation is Only for Internal Use. This Presentation is meant only for giving an overview
TYPES OF DOSAGE FORMS
TYPES OF DOSAGE FORMS Types of dosage forms: Definition: Dosage forms are the means by which drug molecules are delivered to sites of action within the body. The need for dosage forms: 1- Accurate dose.
TENOFOVIR TABLETS: Final text for addition to The International Pharmacopoeia (June 2010)
June 2010 TENOFOVIR TABLETS: Final text for addition to The International Pharmacopoeia (June 2010) This monograph was adopted at the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical
Antonio Hernandez-Cardoso <1239> VACCINES FOR HUMAN USE -- VIRAL VACCINES PF 41(5) Pg. ONLINE
Compendial Cancellations for USP39-NF34 2S Category Monograph Title Monograph Section Scientific Liaison Revision INJECTIONS PF 41(5) Pg. ONLINE INTRODUCTION Desmond Hunt New GOOD DOCUMENTATION
A New USP Tool The Class Monograph
CHPA Regulatory, Scientific & Quality Conference Washington DC, May 13, 2014 Quality Session 4 A New USP Tool The Class Monograph Alan R. Potts, Ph.D. Principal Scientific Liaison-Chemical Medicines The
General Concepts in the European Pharmacopoeia. Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe
General Concepts in the European Pharmacopoeia Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe General notices Anne-Sophie Bouin, 28/10/09 2009 EDQM, Council of Europe, All
New Zealand Regulatory Guidelines for Medicines
New Zealand Regulatory Guidelines for Medicines Part G: Resources Edition 6.14 July 2011 (consolidation of fifth edition and subsequent updates) Table of Contents PART G: RESOURCES Edition 6.14 1 July
Medicaments Administering Injections
Medicaments Administering Injections University of Pécs Faculty of Health Sciences Institute of Nursing Sciences, Basic Health Sciences and Health Visiting Dr. András Oláh 1, Noémi Fullér 2, Gyula Szebeni-Kovács
REGULATORY PERSPECTIVE. Dr. Raghunandan H V Associate Professor JSSCP, JSSU, Mysore
1 REGULATORY PERSPECTIVE Dr. Raghunandan H V Associate Professor JSSCP, JSSU, Mysore Contents 2 1. Role of Dissolution Testing in Generic Drug Approval 2. Dissolution Testing Recommendation for Solid Oral
EDQM Conference. Quality of Medicines in a Globalised World: Dreams and Reality
EDQM Conference Quality of Medicines in a Globalised World: Dreams and Reality 14-15 October 2010 Prague, Czech Republic 2010 EDQM, Council of Europe, All rights reserved Plenary Session Dr Roger L. Williams
EXCIPIENTS FOR PHARMACEUTICALS
EXCIPIENTS FOR PHARMACEUTICALS SCOPE OF APPLICATION IOI Oleo GmbH PHARMA Contents Regulatory background for the IOI Oleo site in Witten: Regulatory background for the IOI Oleo site in Witten... 3 Injectables
IMDG CODE Poison Treatment Chest
2018 IMDG CODE Poison Treatment Chest This document contains the complete list of medicines and medical supplies for the vessels poison treatment chest and is based on the IMDG code international maritime
Etat des travaux du GDP
Etat des travaux du GDP (Avril 2018) Item General methods relevant to Q6A Dissolution (rev. 3) 4 Disintegration (rev. 1) 4 Uniformity of content/mass (rev. 2, corr. 1) 4 Tests for specified microorganisms
ANDA Labeling Question Based Review September 11, 2013 GPhA/FDA ANDA Labeling Workshop/USP User Forum
ANDA Labeling Question Based Review September 11, 2013 GPhA/FDA ANDA Labeling Workshop/USP User Forum Sarah Park, PharmD Jeanne Skanchy, RPh. Labeling Reviewers Office of Generic Drugs/Division of Labeling
USP Perspective on Atypical Actives November 29, 2017
USP Perspective on Atypical Actives November 29, 2017 USP Excipients Stakeholder Forum USP Perspective on Atypical Actives Catherine Sheehan, M.S., M.S. Senior Director, Science Excipients Outline Role
Good pharmacopoeial practices: Chapter on monographs on herbal medicines
Annex 7 Good pharmacopoeial practices: Chapter on monographs on herbal medicines Background Following the fiftieth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations,
DRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA: CARBAMAZEPINI COMPRESSI - CARBAMAZEPINE TABLETS
December 2015 Draft document for comment 1 2 3 4 5 6 DRAFT PROPOSAL FOR THE INTERNATIONAL PHARMACOPOEIA: CARBAMAZEPINI COMPRESSI - CARBAMAZEPINE TABLETS (December 2015) REVISED DRAFT FOR COMMENT Should
Introduction to. Pharmacokinetics. University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D
Introduction to 1 Pharmacokinetics University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D 2 Learning objectives Understand compartment models and how they effects
11:00-11:50 AM 8:00-8:50 AM
5117 5115 5219 5111 5113 5117 5115 5219 5111 5117 5115 5219 5113 5115/5219 5111 5121 01/08 #1 9- MAKE UP 5111 or OR PM See PM See 5113 CH2 S. SCRIPTS 10:00 1- Schedule Schedule Salk 456 or Biosignaling
AUSTRALIAN MADE CAMPAIGN LIMITED
AUSTRALIAN MADE CAMPAIGN LIMITED PHARMACEUTICALS AND COMPLEMENTARY HEALTHCARE PRODUCTS - COMPLIANCE POLICY May 2018 Summary Made Campaign Limited (AMCL) is the t-for-profit organisation which administers
General Pharmacology. Henry: EMT Prehospital Care, Revised 3 rd Edition Lecture Notes Chapter 16: General Pharmacology. Case History.
Henry: EMT Prehospital Care, Revised 3 rd Edition Lecture Notes Chapter 16: General Pharmacology Chapter 16 General Pharmacology Slide 1 Case History You arrive at the home of a patient with chest pain.
EMTRICITABINE AND TENOFOVIR TABLETS
September 2010 RESTRICTED EMTRICITABINE AND TENOFOVIR TABLETS Draft proposal for The International Pharmacopoeia (September2010) REVISED DRAFT FOR COMMENT This document was provided by a quality control
Guideline on pharmaceutical development of medicines for paediatric use
1 2 3 4 3 January 2013 EMA/CHMP/QWP/805880/2012 Rev. 1 Committee for Medicinal Products for Human Use (CHMP) Paediatric Committee (PDCO) 5 6 7 Guideline on pharmaceutical development of medicines for paediatric
Final text for addition to The International Pharmacopoeia (June 2010)
June 2010 KANAMYCIN ACID SULFATE: Final text for addition to The International Pharmacopoeia (June 2010) This monograph was adopted at the Forty-fourth WH Expert Committee on Specifications for Pharmaceutical
CHAPTER 4 Medication Preparation & Supplies
CHAPTER 4 Medication Preparation & Supplies drug form (drug preparation) type of preparation in which the drug is supplied most pharmaceutical companies prepare a drug in a form most suitable for route
FDA s Inactive Ingredient Database Update on the Substance Registration System Changes
FDA s Inactive Ingredient Database Update on the Substance Registration System Changes Priscilla Zawislak Chair Compendial Review Committee IPEC-Americas Global Regulatory Affairs Manager Ashland Inc.
Understanding the links between drug delivery route and in vitro test methods Mark Copley, Sales Director, Copley Scientific
Understanding the links between drug delivery route and in vitro test methods Mark Copley, Sales Director, Copley Scientific In vitro tests are widely used, from R&D through to QC, to improve the efficacy
GUIDANCE DOCUMENT Non-prescription Oral Adult Nasal Decongestant Labelling Standard
GUIDANCE DOCUMENT Decongestant Labelling Standard Published by authority of the Minister of Health Date Adopted 2015/12/17 Effective Date 2015/12/31 Health Products and Food Branch Our mission is to help
ARTESUNATE TABLETS: Final text for revision of The International Pharmacopoeia (December 2009) ARTESUNATI COMPRESSI ARTESUNATE TABLETS
December 2009 ARTESUNATE TABLETS: Final text for revision of The International Pharmacopoeia (December 2009) This monograph was adopted at the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS Draft proposal for The International Pharmacopoeia (September 2010)
September 2010 RESTRICTED SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS Draft proposal for The International Pharmacopoeia (September 2010) REVISED DRAFT FOR COMMENT This document was provided by a quality
CATEGORY IV MONOGRAPH. Athlete's Foot Treatments
CATEGORY IV MONOGRAPH Athlete's Foot Treatments I) Description: This monograph applies to products in cream, ointment, lotion, gel, powder, spray powder, aerosol liquid, solution, foam, or soap form intended