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Best Practices for OINDP Pharmaceutical Development Programs Leachables and Extractables PowerPoint PPT Presentation
Best Practices for OINDP Pharmaceutical Development Programs Leachables and Extractables - ... container labels, administration accessories, shipping containers, etc. Note ... The storage/shipping environment for both components and drug product, if the ...
... container labels, administration accessories, shipping containers, etc. Note ... The storage/shipping environment for both components and drug product, if the ...
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Best Practices for OINDP Pharmaceutical Development Programs PowerPoint PPT Presentation
Best Practices for OINDP Pharmaceutical Development Programs - Analysis of Leachables and Extractables. PQRI Leachables & Extractables ... GC/MS Circa Late 1980s. Circa 2006. September 2006. PQRI Training Course. 12 ...
Analysis of Leachables and Extractables. PQRI Leachables & Extractables ... GC/MS Circa Late 1980s. Circa 2006. September 2006. PQRI Training Course. 12 ...
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Subcommittee Report: Orally Inhaled and Nasal Drug Products (OINDP) PowerPoint PPT Presentation
Subcommittee Report: Orally Inhaled and Nasal Drug Products (OINDP) - Cascade Impactor Deposition Profile Comparison. C.L Leach, Respir Med 1998; ... The relationship of drug deposition on specific stages to safety and efficacy is ...
Cascade Impactor Deposition Profile Comparison. C.L Leach, Respir Med 1998; ... The relationship of drug deposition on specific stages to safety and efficacy is ...
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PTIT for DCU of OINDP: Approaches to Resolution of Identified Issues PowerPoint PPT Presentation
PTIT for DCU of OINDP: Approaches to Resolution of Identified Issues - Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - CMC ... 1 Metered Dose Inhaler and Dry Powder Inhaler CMC Draft Guidance, Oct 1998 ...
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - CMC ... 1 Metered Dose Inhaler and Dry Powder Inhaler CMC Draft Guidance, Oct 1998 ...
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Orally Inhaled and Nasal Drug Products OINDP Subcommittee Report to the Advisory Committee for Pharm PowerPoint PPT Presentation
Orally Inhaled and Nasal Drug Products OINDP Subcommittee Report to the Advisory Committee for Pharm - Division of Pulmonary and Allergy Drug products. Center For Drug Evaluation and Research ... Data from existing products would enable the parametric statistical ...
Division of Pulmonary and Allergy Drug products. Center For Drug Evaluation and Research ... Data from existing products would enable the parametric statistical ...
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History of the PQRI Leachables and Extractables Working Group PowerPoint PPT Presentation
History of the PQRI Leachables and Extractables Working Group - Best Practices for OINDP Pharmaceutical Development Programs Leachables and Extractables PQRI Leachables & Extractables Working Group VI. Characterization of Leachables
Best Practices for OINDP Pharmaceutical Development Programs Leachables and Extractables PQRI Leachables & Extractables Working Group VI. Characterization of Leachables
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Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD PowerPoint PPT Presentation
Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD - Provided input into food effect guidance. Provided input on Biopharmaceutical Classification System (BCS) ... regulate new products, new delivery systems, etc. ...
Provided input into food effect guidance. Provided input on Biopharmaceutical Classification System (BCS) ... regulate new products, new delivery systems, etc. ...
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History of the PQRI Leachables and Extractables Working Group PowerPoint PPT Presentation
History of the PQRI Leachables and Extractables Working Group - Extractables Compounds that can be extracted from elastomeric, ... Diane Paskiet Associate Director of Analytical Laboratories, West Monarch Analytical Labs ...
Extractables Compounds that can be extracted from elastomeric, ... Diane Paskiet Associate Director of Analytical Laboratories, West Monarch Analytical Labs ...
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ITFG/IPAC TECHNICAL TEAM: CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 26 April 2000 Rockville, MD PowerPoint PPT Presentation
ITFG/IPAC TECHNICAL TEAM: CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 26 April 2000 Rockville, MD - ... to relevant development data, pharmacopoeial standards, test data for drug ... products used in toxicology and clinical studies, and results from accelerated ...
... to relevant development data, pharmacopoeial standards, test data for drug ... products used in toxicology and clinical studies, and results from accelerated ...
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Working Group on GMPSupplier QC Presented by Barbara Falco PowerPoint PPT Presentation
Working Group on GMPSupplier QC Presented by Barbara Falco - Barbara Falco, Kos. Chair, IPAC-RS Supplier QC Working Group. IPAC-RS Supplier GMP Workshop ... 1989: International Pharmaceutical Aerosol Consortium (IPAC) ...
Barbara Falco, Kos. Chair, IPAC-RS Supplier QC Working Group. IPAC-RS Supplier GMP Workshop ... 1989: International Pharmaceutical Aerosol Consortium (IPAC) ...
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OVERVIEW OF ITFG/IPAC COLLABORATION Presented by: Harris Cummings, PhD 26 April 2000 Rockville, MD PowerPoint PPT Presentation
OVERVIEW OF ITFG/IPAC COLLABORATION Presented by: Harris Cummings, PhD 26 April 2000 Rockville, MD - OVERVIEW OF ITFG/IPAC COLLABORATION Presented by: Harris Cummings, PhD 26 April 2000 Rockville, MD ITFG IPAC 3M Pharmaceuticals Agouron Aradigm AstraZeneca Aventis ...
OVERVIEW OF ITFG/IPAC COLLABORATION Presented by: Harris Cummings, PhD 26 April 2000 Rockville, MD ITFG IPAC 3M Pharmaceuticals Agouron Aradigm AstraZeneca Aventis ...
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ITFG/IPAC TECHNICAL TEAM: PowerPoint PPT Presentation
ITFG/IPAC TECHNICAL TEAM: - The need for certain tests should be driven by evaluation of ... Guidances should be edited or a separate Guidance should be developed for each dosage form. ...
The need for certain tests should be driven by evaluation of ... Guidances should be edited or a separate Guidance should be developed for each dosage form. ...
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ITFG/IPAC TECHNICAL TEAM: CMC LEACHABLES AND EXTRACTABLES Presented by: Kaushik J. Dave, R.Ph, PhD 26 April 2000 Rockville, MD PowerPoint PPT Presentation
ITFG/IPAC TECHNICAL TEAM: CMC LEACHABLES AND EXTRACTABLES Presented by: Kaushik J. Dave, R.Ph, PhD 26 April 2000 Rockville, MD - Compounds that can be extracted from the elastomeric or plastic components, or ... Analytical Characterization of Extractables (Control Extraction Studies) ...
Compounds that can be extracted from the elastomeric or plastic components, or ... Analytical Characterization of Extractables (Control Extraction Studies) ...
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OVERVIEW OF ITFGIPAC COLLABORATION Presented by: Harris Cummings, PhD 26 April 2000 Rockville, MD PowerPoint PPT Presentation
OVERVIEW OF ITFGIPAC COLLABORATION Presented by: Harris Cummings, PhD 26 April 2000 Rockville, MD - ... Pharmaceutical Aerosol Consortium (IPAC) is an association of companies that ... than 85 pharmaceutical scientists from more than 20 companies have been working ...
... Pharmaceutical Aerosol Consortium (IPAC) is an association of companies that ... than 85 pharmaceutical scientists from more than 20 companies have been working ...
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The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays: History, Recommendations and Local Delivery Issues PowerPoint PPT Presentation
The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays: History, Recommendations and Local Delivery Issues - Lydia Gilbert-McClain Robert Meyer. Gur Jai Pal Singh (Chair) Wallace Adams Dale Conner ... Eugene Sullivan. Wallace Adams (Chair) James Allgire Charles ...
Lydia Gilbert-McClain Robert Meyer. Gur Jai Pal Singh (Chair) Wallace Adams Dale Conner ... Eugene Sullivan. Wallace Adams (Chair) James Allgire Charles ...
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Dose Content Uniformity for Aerosol Products PowerPoint PPT Presentation
Dose Content Uniformity for Aerosol Products - RL Williams et al, Pharm Res, 2002;19:359-66 ... Meiyu Shen (FDA) Yi Tsong (FDA) Walter Hauck (Thomas Jefferson University) Roger Williams (USP) ...
RL Williams et al, Pharm Res, 2002;19:359-66 ... Meiyu Shen (FDA) Yi Tsong (FDA) Walter Hauck (Thomas Jefferson University) Roger Williams (USP) ...
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ORALLY INHALED AND NASAL DRUG PRODUCTS FOR LOCAL ACTION Current FDA BA/BE Background and Issues PowerPoint PPT Presentation
ORALLY INHALED AND NASAL DRUG PRODUCTS FOR LOCAL ACTION Current FDA BA/BE Background and Issues - and does not necessarily represent the views or policies of US FDA. 2 ... Day(s) in the Park Study: ... Based on the ability of albuterol to dilate airways ...
and does not necessarily represent the views or policies of US FDA. 2 ... Day(s) in the Park Study: ... Based on the ability of albuterol to dilate airways ...
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Orally Inhaled and Nasal Drug Products Subcommittee PowerPoint PPT Presentation
Orally Inhaled and Nasal Drug Products Subcommittee - Address and discuss questions related to the content uniformity of orally ... model, trials with surrogate measures such as exhaled nitric oxide (eNO), etc. ...
Address and discuss questions related to the content uniformity of orally ... model, trials with surrogate measures such as exhaled nitric oxide (eNO), etc. ...
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Drug Discovery and Development Process of Anti-diabetic Plants PowerPoint PPT Presentation
Drug Discovery and Development Process of Anti-diabetic Plants - Drug Discovery and Development Process of Anti-diabetic Plants Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Professor of Pharmaceutics KLE University College of Pharmacy
Drug Discovery and Development Process of Anti-diabetic Plants Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Professor of Pharmaceutics KLE University College of Pharmacy
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DEBATING THE OPERATING CURVES FOR DDU TESTS ON MARKETED INHALERS PowerPoint PPT Presentation
DEBATING THE OPERATING CURVES FOR DDU TESTS ON MARKETED INHALERS - ... in 2004 under FDA Advisory Committee for Pharmaceutical Science (ACPS) Populated by senior representatives from FDA and technical experts from OINDP industry ...
... in 2004 under FDA Advisory Committee for Pharmaceutical Science (ACPS) Populated by senior representatives from FDA and technical experts from OINDP industry ...
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