'Drug substance' diaporamas de présentation

ABBRIVIATED NEW DRUG PPLICATION (ANDA)

SEMINAR ON:. ABBRIVIATED NEW DRUG PPLICATION (ANDA). Presented by: Nagori Stavan Arunkumar Department of Pharmaceutics L.M.College of Pharamcy. ANDA. Pool of topics:. Introduction History of ANDA Guidelines available for ANDA Filling of ANDA

2.2k views • 129 slides

BIOPHARMACEUTICAL DEVELOPMENT & REGULATION

BIOPHARMACEUTICAL DEVELOPMENT & REGULATION. Ron Guido Alan McEmber. Course Details. Fall 2007: W4200 Section 001 : BIOPHARMACEUTICAL DEVELOPMENT & REGULATION Meets: Thursday 2:40pm-4:40pm Location: 1000 Sherman Fairchild Life Sciences Building Instructors: Ron Guido, Alan McEmber

858 views • 49 slides

Active Pharmaceutical Ingredient (API)

Active Pharmaceutical Ingredient (API). Lynda Paleshnuik. Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009. Overview. CTD organization of the API Common deficiencies on a section-by-section basis DMF/APIMF Overview Use of the DMF/APIMF procedure

1.44k views • 47 slides

DRUG MASTER FILES

DRUG MASTER FILES. / 45. CONTENTS:-. Introduction Some basic terminologies. Types of DMFS with their contents. Submissions to drug master files Authorization to refer to a drug master file Processing and reviewing policies Holder obligations

2.07k views • 45 slides

Saravanaraja Subramanian

882 views • 45 slides

560 views • 41 slides

Alternative Medicine Homeopathy

658 views • 38 slides

Drug Master Files Global Perspectives

745 views • 37 slides

1.83k views • 34 slides

CONFLICT OF INTEREST STATEMENT Leslie Z. Benet, Ph.D.

Epidemiology 260 Drug and Device Development April 15, 2010 Leslie Z. Benet, PhD Department of Bioengeering and Therapeutic Sciences Schools of Pharmacy and Medicine.

479 views • 32 slides

Erika Stippler, Ph.D. Director Dosage Form Performance Laboratory

6 th Annual Science and Standards Symposium January 16, 2013 Istanbul Determination of Solubility and Permeability in BCS. Erika Stippler, Ph.D. Director Dosage Form Performance Laboratory. BCS Concept. Published by Amidon and co-workers 1995

669 views • 32 slides

Applications of Analytical Chemistry in Pharmaceuticals

Applications of Analytical Chemistry in Pharmaceuticals. Corey M. Chong 10Mar10. Topics of Discussion. What to test: the drug product Why to test: the Code of Federal Regulations (CFRs) How to test: compendial and non-compendial methods presented in regulatory documents (IND/NDA).

926 views • 31 slides

The Role of Chemists in the FDA Drug Approval Process

The Role of Chemists in the FDA Drug Approval Process. 231 st ACS National Meeting Atlanta, GA M. Scott Furness, Ph.D. March 26, 2006. Presentation Outline. Introduction FDA Organization CDER Organization Drug Approval Process Role of Chemistry Reviewers within CDER

435 views • 24 slides

Drug - Device Combination Issues : Oncology Perspective

Drug - Device Combination Issues : Oncology Perspective . Ramzi Dagher, M.D. DODP/CDER/FDA. Drug - Device . Goals optimize efficacy limit toxicity Approaches in Oncology hyperthermia light activation electroporation novel delivery formulations. Multidisciplinary Challenges.

357 views • 14 slides

Predicting Physical Stability in Q1A(R)

Predicting Physical Stability in Q1A(R). Chi-wan Chen, Ph.D. Office of New Drug Chemistry Center for Drug Evaluation and Research Food and Drug Administration Pharmaceutical Science Advisory Committee November 28, 2001. Stress Testing of Drug Substance.

317 views • 10 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

1.18k views • 9 slides

Introduction to Drugs

Introduction to Drugs. Drugs in America. Is there a problem? National Drug Control Strategy Plan to decrease drug use and availability in half in 10 yrs. Definitions. Drug Mind and behavior changing substance

1.79k views • 8 slides

Replagal TM Gene Activated Human a Galactosidase

288 views • 5 slides

Percentage and Ratio Strength Calculations

Percentage and Ratio Strength Calculations. Percentage. Percent weight-in-volume (w/v): The number of grams of a constituent in 100 ml of solution or liquid preparation. -The term used for solutions or suspensions of solids in liquids.

505 views • 5 slides

Regulatory affairs

Regulatory affairs. The Regulatory affairs department plays a key role in ensuring that your future or existing product will comply with the permanently updated guidelines and recommendations of the regulatory bodies in France, European Union and United States. Full development package.

206 views • 1 slides