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1. Scale - Up and Post Approval ChangesSUPACPresented By:- SoniaP. Nagvenkar1 2. IndexDefinitionScientific RationalSUPAC Guidelines – SUPAC IR, SUPAC – MR, SUPAC –SSLevels…

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1. (NEW DRUG APPLICATION)R.MEENAKSHIM Pharm (Pharm. Chemistry)1 2. CONTENTSINTRODUCTIONHISTORYNDA APPROVAL PROCESSREVIEW PROCESSADVISORY…

Technology Med e hub - e-library for healthcare reimbursement - january13

1. The evergreen Consulting LibraryforHealthcare Reimbursement & EconomicsNEW January 2013 2. Get 24/7 access to:• focused, evergreen research that nevergoes out of…

Healthcare Regulation on new drugs

REGULATION ON NEW DRUGS PRATEEK CHHAJER PGDPM-05 200 IIHMR INTRODUCTION New drugs as define under Rule 122-E of D&C Rules include unapproved drugs, modified or new claims,…

Health & Medicine Impurities

IMPURITIES Impurity: Any component of the new drug substance that is not the chemical entity defined as the new drug substance. Impurity Profile: A description of the identified…

Education Gamification for Beginners

1. 2015 GAMIFICATION FOR BEGINNERS Chuck Campbell 2. ABCDEFGHIJKLMNOPQRSTUVWXYZ ABCDEFGHIJKLMNOPQRSTUVWXYZ ABCDEFGHIJKLMNOPQRSTUVWXYZ ABCDEFGHIJKLMNOPQRSTUVWXYZ What is the…

Documents Quality Assurance & Quality Control In Pharma Industry Dr. Basavaraj K. Nanjwade M.Pharm., Ph. D...

Slide 1 Quality Assurance & Quality Control In Pharma Industry Dr. Basavaraj K. Nanjwade M.Pharm., Ph. D Associate Professor of Pharmaceutics Department of Pharmaceutics…

Documents PHYSIOLOGICAL AND LABORATORY MARKERS OF DRUG EFFECT Arthur J. Atkinson, Jr., M.D. Senior Advisor in....

Slide 1 PHYSIOLOGICAL AND LABORATORY MARKERS OF DRUG EFFECT Arthur J. Atkinson, Jr., M.D. Senior Advisor in Clinical Pharmacology Clinical Center, NIH Slide 2 USES OF BIOMARKERS…

Documents 1 Exercise 13 Deconvolution analysis vs. modeling to document the process of drug absorption.

Exercise 13 Deconvolution analysis vs. modeling to document the process of drug absorption Objectives To implement a WNL user model for a monocompartmental model with two…

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CLINICAL PHARMACOLOGY REVIEW NDA Number (s) 22-009 Submission Date(s) May 31st, 2007 Helioblock ® SX Sunscreen Cream (SPF 40) Brand Name(s) Brand Names are currently being…