دانلود مقالات ISI درباره علم مقررات + ترجمه فارسی

The Utility of Modeling and Simulation in Drug Development and Regulatory Review

Keywords: علم مقررات; regulatory science; PBPK; Modeling and simulation; systems pharmacology; pharmacodynamics; drug interactions; dose‐response; pharamcokinetics

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2013 سفارش ترجمه

Challenging the bioeconomy: The dynamics of collective action in Argentina

Keywords: علم مقررات; Bioeconomy; Regulatory science; Social movements; Argentina; Biotechnology; Latin America

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2013 سفارش ترجمه

Application of Quality by Design Concepts in the Development of Fluidized Bed Granulation and Tableting Processes

Keywords: علم مقررات; fluid bed; granulation; tableting; regulatory science; factorial design; multivariate analysis; partial least squares; principal component analysis; dissolution rate;

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2013 سفارش ترجمه

The Assessment of Impurities for Genotoxic Potential and Subsequent Control in Drug Substance and Drug Product

Keywords: علم مقررات; genotoxic impurities; analytical chemistry; toxicology; regulatory science; in silico modeling; stability; degradation; control strategy; risk assessment; threshold of toxicological concern;

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2013 سفارش ترجمه

Transgene mobilization and regulatory uncertainty for non-GE fruit products of transgenic rootstocks

Keywords: علم مقررات; Transgenic rootstock; SiRNA mobility; Regulatory science; Walnut transgraft;

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2012 سفارش ترجمه

The ability of animal studies to detect serious post marketing adverse events is limited

Keywords: علم مقررات; Predictive value; Animal studies; Non-clinical drug development; Serious adverse reactions; Pharmacovigilance; Regulatory science;

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2012 سفارش ترجمه

Impact of regulatory science on global public health

Keywords: علم مقررات; Globalization; Innovation; Regulatory science

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2012 سفارش ترجمه

Transepithelial transport of biperiden hydrochloride in Caco-2 cell monolayers

Keywords: علم مقررات; Biopharmaceutics Classification System (BCS); Caco-2 cells; Permeability; Regulatory science; Biperiden hydrochloride

دانلود رایگان متن کامل مقاله ISI 5 صفحه سال انتشار : 2012 سفارش ترجمه

The future of protein particle characterization and understanding its potential to diminish the immunogenicity of biopharmaceuticals: A shared perspective

Keywords: علم مقررات; immunology; protein aggregation; protein formulation; stability; regulatory science; biotechnology; microparticles; nanoparticles; therapeutic drug monitoring;

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2012 سفارش ترجمه

Current situation of clinical trials in Beijing, China

Keywords: علم مقررات; Good Clinical Practice; Regulatory science; Global clinical trial; Asian clinical trial network; Beijing

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2012 سفارش ترجمه

A survey of Top 200 Drugs-Inconsistent Practice of Drug Strength Expression for Drugs Containing Salt Forms

Keywords: علم مقررات; regulatory science; preformulation; formulation; physicochemical; physicochemical properties; acid/base;

دانلود رایگان متن کامل مقاله ISI 6 صفحه سال انتشار : 2012 سفارش ترجمه

Inclusion of Human Intravenous Study Data in New Drug Applications-Impact of the Japanese Guidance

Keywords: علم مقررات; clinical pharmacokinetics; bioavailability; regulatory science; pharmacokinetics; solubility; intravenous administration; new drug application; guidance;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2012 سفارش ترجمه

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Stavudine

Keywords: علم مقررات; stavudine; absorption; Biopharmaceutics Classification System (BCS); permeability; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2012 سفارش ترجمه

The placebo arm in clinical studies for treatment of Psychiatric Disorders: A Regulatory Dilemma

Keywords: علم مقررات; Clinical trial; Placebo; Psychiatry; Psychopharmacology; Regulatory science

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2012 سفارش ترجمه

The Potential Clinical Relevance of Visible Particles in Parenteral Drugs

Keywords: علم مقررات; injectables; regulatory science; particles; particle size; physicochemical properties; precipitation; thromboembolism; distribution; toxicity;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2012 سفارش ترجمه

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Quinine Sulfate

Keywords: علم مقررات; absorption; bioavailability; bioequivalence; Biopharmaceutics Classification System (BCS); quinine; permeability; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2012 سفارش ترجمه

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Ketoprofen

Keywords: علم مقررات; ketoprofen; absorption; Biopharmaceutics Classification System (BCS); permeability; solubility; dissolution; regulatory science;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2012 سفارش ترجمه

Type 2 Diabetes in Pediatrics and Adults: Thoughts from a Clinical Pharmacology Perspective

Keywords: علم مقررات; pediatric type 2 diabetes; metformin; rosiglitazone; glimepiride; pharmacokinetics; pharmacodynamics; Pediatric; Regulatory Science; Clinical Pharmacokinetics;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2012 سفارش ترجمه

Utility of standard pharmacopeial and nonpharmacopeial methods in distinguishing folded, unfolded, and process variant forms of interferon α-2

Keywords: علم مقررات; biopharmaceuticals characterization; circular dichroism; capillary electrophoresis; fluorescence spectroscopy; HPLC (high-performance/pressure liquid chromatography); mass spectrometry; protein aggregation; proteins; regulatory science; thermal analysis;

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2012 سفارش ترجمه

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: Towards a global multi‐step design space

Keywords: علم مقررات; Quality by Design; design space; proteins; validation; biotechnology; mathematical models; regulatory science; multivariate analysis;

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2012 سفارش ترجمه

Investigation on the Possibility of Biowaivers for Ibuprofen

Keywords: علم مقررات; bioequivalence; Biopharmaceutics classification system (BCS); dissolution; regulatory science; solubility; permeability; absorption;

دانلود رایگان متن کامل مقاله ISI 7 صفحه سال انتشار : 2011 سفارش ترجمه

A Randomized, Quadruple Crossover Single-Blind Study on Immediate Action of Chewed and Unchewed Low-Dose Acetylsalicylic Acid Tablets in Healthy Volunteers

Keywords: علم مقررات; absorption; clinical pharmacokinetics; clinical trials; food effects; formulation; gastrointestinal transit; pharmacodynamics; tablet; regulatory science

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2011 سفارش ترجمه

Ensuring Global Access to Quality Medicines: Role of the US Pharmacopeia

Keywords: علم مقررات; formulation; international health; quality; regulatory science; stability; therapeutic drug monitoring; US Pharmacopeial Convention;

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2011 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levofloxacin

Keywords: علم مقررات; levofloxacin; absorption; Biopharmaceutics Classification System (BCS); permeability; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2011 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metronidazole

Keywords: علم مقررات; dissolution; absorption; Biopharmaceutics Classification System (BCS); metronidazole; permeability; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2011 سفارش ترجمه

Regulatory Considerations for Clinical Mass Spectrometry: Multiple Reaction Monitoring

Keywords: علم مقررات; Clinical proteomics; Multiplex; Multiple reaction monitoring mass spectrometry; In vitro diagnostics; Regulatory science;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2011 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ciprofloxacin Hydrochloride

Keywords: علم مقررات; absorption; biopharmaceutics classification system (BCS); ciprofloxacin; dissolution; permeability; regulatory science; solubility

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2011 سفارش ترجمه

A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design

Keywords: علم مقررات; quality by design (QbD); process validation; design space; risk assessment; process robustness; protein formulation; unit operations; regulatory science; biotechnology; mixing;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2011 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Furosemide

Keywords: علم مقررات; furosemide; absorption; bioequivalence; Biopharmaceutics Classification System (BCS); permeability; solubility; regulatory science;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2010 سفارش ترجمه

Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclate**

Keywords: علم مقررات; absorption; biopharmaceutics classification system (BCS); doxycycline hyclate; permeability; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 15 صفحه سال انتشار : 2010 سفارش ترجمه

Cascade Impactor Practice for a High Dose Dry Powder Inhaler at 90 L/min: NGI Versus Modified 6-Stage and 8-Stage ACI

Keywords: علم مقررات; aerodynamic diameter; aerosols; bioequivalence; cascade impactor; formulation; dry powder inhaler; particle size; regulatory science; silicone coating; USP;

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2009 سفارش ترجمه

Biowaiver monographs for immediate release solid oral dosage forms: Quinidine sulfate

Keywords: علم مقررات; absorption; dissolution; Biopharmaceutics Classification System (BCS); permeability; regulatory science; quinidine sulfate; solubility;

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2009 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

Keywords: علم مقررات; absorption; bioequivalence; biopharmaceutics; classification; system (BCS); diclofenac; permeability; solubility; regulatory science;

دانلود رایگان متن کامل مقاله ISI 14 صفحه سال انتشار : 2009 سفارش ترجمه

Development of Calcitonin Salmon Nasal Spray: Similarity of Peptide Formulated in Chlorobutanol Compared to Benzalkonium Chloride as Preservative

Keywords: علم مقررات; nasal drug delivery; nuclear magnetic resonance (NMR) spectroscopy; physical characterization; physicochemical properties; regulatory science; stability;

دانلود رایگان متن کامل مقاله ISI 16 صفحه سال انتشار : 2009 سفارش ترجمه

Biowaiver monographs for immediate release solid oral dosage forms: Rifampicin

Keywords: علم مقررات; absorption; dissolution; biopharmaceutics classification system (BCS); permeability; regulatory science; rifampicin; solubility;

دانلود رایگان متن کامل مقاله ISI 16 صفحه سال انتشار : 2009 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage forms: Metoclopramide Hydrochloride

Keywords: علم مقررات; absorption; bioequivalence; biopharmaceutics classification system (BCS); dissolution; metoclopramide; permeability; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2008 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Acetazolamide

Keywords: علم مقررات; acetazolamide; dissolution; absorption; Biopharmaceutics Classification System (BCS); permeability; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2008 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ethambutol Dihydrochloride**

Keywords: علم مقررات; absorption; Biopharmaceutics Classification System (BCS); ethambutol; permeability; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2008 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Pyrazinamide**

Keywords: علم مقررات; absorption; bioequivalence; biopharmaceutics classification system (BCS); dissolution; permeability; pyrazinamide; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 12 صفحه سال انتشار : 2008 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Aciclovir

Keywords: علم مقررات; absorption; aciclovir; bioequivalence; biopharmaceutics classification system (BCS); permeability; solubility; regulatory science;

دانلود رایگان متن کامل مقاله ISI 13 صفحه سال انتشار : 2008 سفارش ترجمه

Pediatric Drugs-A Review of Commercially Available Oral Formulations

Keywords: علم مقررات; pediatric; formulation; suspensions; physical stability; oral drug delivery; excipients; chemical stability; solid dosage form; solid-state stability; regulatory science; AUC, area-under-the-curve; BMS, Bristol-Myers Squibb Company; b.i.d., twice-a-day; C

دانلود رایگان متن کامل مقاله ISI 44 صفحه سال انتشار : 2008 سفارش ترجمه

Conference Report: Bio-International 2005

Keywords: علم مقررات; bioequivalence; bioavailability; Biopharmaceutics Classification System; regulatory science; transdermal;

دانلود رایگان متن کامل مقاله ISI 8 صفحه سال انتشار : 2007 سفارش ترجمه

Pure science or policy involvement? Ambiguous boundary-work for Swedish carbon cycle science

Keywords: علم مقررات; Science–policy interplay; Regulatory science; Co-production; Knowledge broker; Kyoto protocol; LULUCF

دانلود رایگان متن کامل مقاله ISI 9 صفحه سال انتشار : 2007 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Prednisone

Keywords: علم مقررات; absorption; bioequivalence; biopharmaceutics classification system (BCS); permeability; prednisone; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2007 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Isoniazid*

Keywords: علم مقررات; absorption; biopharmaceutics classification system (BCS); permeability; solubility; regulatory science;

دانلود رایگان متن کامل مقاله ISI 10 صفحه سال انتشار : 2007 سفارش ترجمه

Biowaiver Monographs for Immediate Release Solid OralDosage Forms: Prednisolone

Keywords: علم مقررات; absorption; bioequivalence; Biopharmaceutics Classification System (BCS); permeability; prednisolone; regulatory science; solubility;

دانلود رایگان متن کامل مقاله ISI 11 صفحه سال انتشار : 2007 سفارش ترجمه

A Risk-Based Approach to Establish Stability Testing Conditions for Tropical Countries

Keywords: علم مقررات; physicochemical properties; tropical climate; hot and humid; high humidity; testing condition; safety margin; climatic zone; thermodynamics; stability; regulatory science;

دانلود رایگان متن کامل مقاله ISI 20 صفحه سال انتشار : 2006 سفارش ترجمه