'Drug product' presentation slideshows

Pharmacy Manpower 2020: Meeting Needs of Patients

1.62k views • 96 slides

FDA cGMP Training Program

FDA cGMP Training Program. cGMP in the USA Nicholas Buhay Deputy Director Division of Manufacturing & Product Quality Office of Compliance, CDER, FDA. Introduction to Drug. Current Good Manufacturing Practice Of US FDA. An Outline. Legal bases for CGMP CGMP legal principles

1.52k views • 55 slides

Pre-qualification Program: Priority Medicines Interchangeability of Multi Source Drug Products

Pre-qualification Program: Priority Medicines Interchangeability of Multi Source Drug Products. Interchangeability of Multisource Drug Products Containing Highly Variable Drugs .

913 views • 53 slides

Dosage Form Design Lecture 5 and 6 Dr . Athmar Dhahir Habeeb

Dosage Form Design Lecture 5 and 6 Dr . Athmar Dhahir Habeeb PhD in Industrial pharmacy and drug delivery athmar1978@uomustansiriyah.edu.iq athmar1978@yahoo.com a th mar.habeeb.12@ucl.ac.uk. Current Good Manufacturing Practices cGMP Current Good Compounding Practices cGCP. c GMP.

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567 views • 42 slides

Is it potent? Can these results tell me? Statistics for assays

Is it potent? Can these results tell me? Statistics for assays. Ann Yellowlees PhD Quantics Consulting Limited. Contents. Role of statistics in bioassay Regulations Estimating Relative Potency Choice of model for RP estimation Parallelism Case study. Role of statistics in bioassay.

500 views • 37 slides

Kerry Maloney, Esq., General Counsel, and

What Every Pennsylvania Pharmacy Needs to Know about State Board of Pharmacy Compounding Regulations. Kerry Maloney, Esq., General Counsel, and Gayle A Cotchen, RPh MBA PharmD, Acute Care Institutional Member Both are employees of the Pennsylvania State Board of Pharmacy. Disclaimer.

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U.S. Food and Drug Administration

536 views • 25 slides

Internship and Licensure Requirements

Internship and Licensure Requirements. Jesse C. Vivian, BS Pharm, JD Professor Department of Pharmacy Practice jessevivian@wayne.edu http://jessevivian.org. Selected Portions of the Michigan Public Health Code-. Part 177 Pharmacy Practice Statutes-MCL 333.177xx

453 views • 25 slides

Determination of toxic (harmful) dose in children: an industry approach

Determination of toxic (harmful) dose in children: an industry approach. Soraya Madani, PhD Exploratory Clinical Development Novartis Pharmaceuticals ANEC Konferenz Kindersichere Verpackungen Conference on 23 Sept 04 Packaging of Medicines and the Safety of Children.

565 views • 22 slides

Direct-to-Consumer Advertising of Prescription Drugs: The Year in Review

Direct-to-Consumer Advertising of Prescription Drugs: The Year in Review. Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and Communications, FDA DTC National April 27, 2006. Talk Outline. Major influences in 2005 The year in DTC What is next?. Requirements for Ads.

319 views • 21 slides

Look-Alike and Sound-Alike Medications Practitioner Perspectives

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Look-Alike and Sound-Alike Medications Practitioner Perspectives

1.02k views • 20 slides

?????????? The API Regulation System of China

?????????? The API Regulation System of China. ??? (SUN Yueping) ?????? TB FDC ?????? 2010 ? 3 ?. Contents. 1. Related background 2. Differences in legal definition of drug and approval system 3. Difference in regulatory system of drug substances between China and foreign countries

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712 views • 17 slides

Pharmaceutical Care Assessment

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Module 2

Module 2. Christa Clasen Ankara, 6./7. April 2006. Module 2. 2.1 Table of Content 2.2 Introduction 2.3 Quality Overall Summary 2.4 Nonclinical Overview 2.5 Clinical Overview 2.6 Non-clinical Summary 2.7 Clinical Summary. 2.1 Table of Content.

529 views • 13 slides

Investigational New Drugs (INDs) Phase 1 CMC Issues

Investigational New Drugs (INDs) Phase 1 CMC Issues. Moheb Nasr, Ph.D. Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee for Pharmaceutical Science Manufacturing Subcommittee July 20-21, 2004. Primary Objectives of IND. Phase 1: Safety

1.19k views • 9 slides

Label of the Drug Product

Label of the Drug Product. Retail drug product Legal rules for what is to appear on the label on a retail dispensed drug product comes from the FDCA on the federal level and also from the state. The USP in 2012 has also published guidelines as well Name, address and phone of pharmacy

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