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Excipient
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#	Item
151	Draft Guidelines on the Formalised Risk Assessment for Ascertaining the Appropriate GMG for Excipients of Medicinal Products for Human Use General remark Most of the additives (including the colouring materials) intended Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-11-07 08:57:29 Pharmaceutical sciences Risk Management Pharmacology Pharmaceuticals policy Good manufacturing practice Excipient Quality management system Hazard analysis and critical control points Pharmaceutical industry Food safety Hazard analysis
152	Portrait of a cheerful boy with loving parents and grandparents Add to Reading List Source URL: www.egagenerics.com Language: English Dosage forms Medicine Pharmacopoeias Clinical research Excipient Tablet European Pharmacopoeia British Pharmacopoeia Pharmaceutical sciences Pharmacology Pharmaceutical industry
153	CHEMICAL PHARMACEUTICAL AND BIOLOGICAL DATA Introduction The product to be used is Wonderdrug 5mg Tablets which are blinded for use in the trial by encapsulation using a Swedish Orange capsule (body and cap) and back-fil Add to Reading List Source URL: www.mhra.gov.uk Language: English - Date: 2010-04-07 12:39:26 Dosage forms Pharmacy Clinical research Excipient Gelatin Capsule Tablet Pharmaceutical formulation Microcrystalline cellulose Pharmaceutical sciences Pharmaceutical industry Pharmacology
154	DOC Document Add to Reading List Source URL: www.mhra.gov.uk Language: English - Date: 2010-03-25 07:29:18 Benzimidazoles Pyridines AstraZeneca Sulfoxides Omeprazole Methadone Orlistat Excipient Lysergic acid diethylamide Chemistry Organic chemistry Eli Lilly and Company
155	Dear Sirs, I am writing on behalf of Genus Pharmaceuticals Ltd in the UK. Our organisation has less than 250 employees and have an annual turnover of >€50 million. We hold a UK Manufacturer’s/Importer’s Authorisa Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-11-07 08:57:19 Research Pharmaceuticals policy Science Pharmacology Food safety Good manufacturing practice Validation Excipient Risk assessment Pharmaceutical industry Clinical research Risk
156	Example QbD MR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development Quality by Design for ANDAs: An Example for Modified Release Dosage Forms Introduction to the Example Add to Reading List Source URL: www.fda.gov Language: English Dosage forms Chemistry Tablet Excipient Time release technology Quality by Design Formulation Dissolution testing Capsule Pharmacology Pharmaceutical sciences Pharmaceutical industry
157	Guidance for Industry Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Research Clinical pharmacology Food and Drug Administration Bioequivalence Abbreviated New Drug Application In vitro Excipient Validation Pharmaceutical sciences Clinical research Pharmaceutical industry
158	Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Clinical research Dosage forms Pharmacokinetics Dissolution testing Bioequivalence Food and Drug Administration Excipient Generic drug Pharmaceutical sciences Pharmaceutical industry Pharmacology
159	Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Medicine Food and Drug Administration Dosage forms Clinical research Excipient Pre-clinical development Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Drug Master File Pharmaceutical sciences Pharmacology Pharmaceutical industry
160	Also, please note that two method validation reports: Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Research Quality Validation Validity Biogen Idec Excipient Food and Drug Administration Pharmaceutical sciences Clinical research Pharmaceutical industry

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