Keywords: برنامه دارویی جدید; Degradation products; Impurities; International chemical reference substances; Pharmacopoeial standards; Reference standards; Primary reference standards; Secondary reference standards; Working standards; AAS; atomic absorption spectroscopy; ANDA; abbrevi
مقالات ISI برنامه دارویی جدید (ترجمه نشده)
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Keywords: برنامه دارویی جدید; Polymers; Ocular drug delivery; Nanoparticles; Microparticles; Gels; Ocular bioavailability; ABC; ATP-binding cassette superfamily; ANDA; Abbreviated new drug application; AUC; Area-under-the-curve; BSA; Bovine serum albumin; DDS; Drug delivery system; EP
Comparability study of Rituximab originator and follow-on biopharmaceutical
Keywords: برنامه دارویی جدید; AA; amino acid; ABC; ammonium bicarbonate; ACN; acetonitrile; ADCC; antibody-dependent cellular cytotoxicity; CD; circular dichroism; CDC; complement-dependent cytotoxicity; CDRs; complementarity determining regions; CH; constant region of heavy chain; CH
Keywords: برنامه دارویی جدید; 2D-LC; two-dimensional liquid chromatography; AA; amino acid; AC; affinity chromatography; ADC; antibody-drug conjugates; ADCC; antibody-dependent cellular cytotoxicity; AF4; asymmetric flow field fractionation; APTS; 1-aminopyrene-3,6,8-trisulfonate; Asn
Keywords: برنامه دارویی جدید; AUC; Area under the concentration-time curve; DR; Delayed release; eGFR; Estimated glomerular filtration rate; FDA; Food and Drug Administration; GLP-1; Glucagon-like peptide 1; MALA; Metformin-associated lactic acidosis; NDA; New Drug Application; XR;
Keywords: برنامه دارویی جدید; Botanical; Regulation; Investigational New Drug; IND; New Drug Application; NDA; New drug approval; Drug development; Food and Drug Administration
Keywords: برنامه دارویی جدید; ANDA; Abbreviated New Drug Application; BBB; blood-brain barrier; FDA; Food and Drug Administration; L-DOPA; L-3,4-dihydroxyphenylalanine; MEMS; microelectromechanical systems; NDA; New Drug Application; PTH; parathyroid hormone; SC; subcutaneous; SNHL;
Keywords: برنامه دارویی جدید; ANDA; Abbreviated New Drug Application; ER/LA; extended-release/long-acting; ETASU; Elements to Assure Safe Use; FDA; Food and Drug Administration; FDAAA; FDA Amendments Act; MedGuides; Medication Guides; NDA; New Drug Application; PDUFA V; Prescription D
Keywords: برنامه دارویی جدید; ADR; adenoma detection rate; CI; confidence interval; CRC; colorectal cancer; FDA; Food and Drug Administration; ITT; intention-to-treat; NaP; sodium phosphate; NDA; New Drug Application; OR; odds ratio; OSS; oral sulfate solution; OTC; over-the-counter;
Keywords: برنامه دارویی جدید; Colonoscopy Preparation; Colonoscopy Quality; Colonoscopy; Colon Cancer Screening; Colon Polyp Detection; Bowel Preparations; ADR; adenoma detection rate; CI; confidence interval; CRC; colorectal cancer; FDA; Food and Drug Administration; ITT; intention-t
Keywords: برنامه دارویی جدید; VVA; vulvovaginal atrophy; SERM; selective estrogen receptor modulator; NDA; new drug application; FDA; Food and Drug Administration; NSABP; National Surgical Adjuvant Breast & Bowel Project; STAR; Study of Tamoxifen and Raloxifene; ER; estrogen receptor;
In vitro secondary pharmacological profiling: An IQ-DruSafe industry survey on current practices
Keywords: برنامه دارویی جدید; AUC; Area Under the Curve; CRO; Contract Research Organization; CTA; Clinical Trial Authorization; GLP; Good Laboratory Practice; hERG; human ether-a-go-go-related gene; ICH; International Conference on Harmonization; IND; Investigational New Drug; IQ; In
Regulatory-accepted drug development tools are needed to accelerate innovative CNS disease treatments
Keywords: برنامه دارویی جدید; ACR; American College of Radiology; AD; Alzheimer disease; ADNI; Alzheimer's Disease Neuroimaging Initiative; ALS; Amyotrophic Lateral Sclerosis; ASD; Autism Spectrum Disorder; BBB; Blood-Brain-Barrier; BEST; Biomarkers, Endpoints and other Tools; BLA; Bi
A pragmatic method for transforming clinical research data from the research electronic data capture “REDCap” to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM
Keywords: برنامه دارویی جدید; CDISC; Clinical Data Interchange Standards Consortium; SDTM; Study Data Tabulation Model; CDASH; Clinical Data Acquisition Standards Harmonization; EDC; electronic data capture; ODM; Operational Data Model; ADaM; Analysis Data Model; FDA; Food and Drug Ad
Method of data interpretation for the determination of abuse liability in rodent self-administration studies under the FDA guidance document
Keywords: برنامه دارویی جدید; Self-administration; Drug control policy; Extinction; Reinforcement; Acute reinforcer; Acute tolerance; Methods; FDA; DEA; New drug application;
Current FDA regulatory guidance on the conduct of drug discrimination studies for NDA review: Does the scientific literature support recent recommendations?
Keywords: برنامه دارویی جدید; Drug discrimination; Stimulus control; Drug control policy; Extinction; Reinforced test session; FDA; DEA; New drug application;
Oral delivery of macromolecular drugs: Where we are after almost 100Â years of attempts
Keywords: برنامه دارویی جدید; ADH; anti-diuretic hormone; AON; antisense oligonucleotide; 5-CNAC; N-(5-chlorosalicyloyl)-8-aminocaprylic acid; EDTA; ethylenediaminetetraacetate; FDA; Food and Drug Administration; GC C; guanylyl cyclase C; GI; gastrointestinal; GLP-1; glucagon-like pep
A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee
Keywords: برنامه دارویی جدید; ADRs; adverse drug reactions; CDER; Center for Drug Evaluation and Research; cTn; cardiac troponin; CV; cardiovascular; EMA; European Medicines Agency; EWG; Expert Working Group; ECG; electrocardiogram; HESI; Health and Environmental Sciences Institute; h
A pre-marketing ALT signal predicts post-marketing liver safety
Keywords: برنامه دارویی جدید; DILI; drug induced liver injury; FDA; Food and Drug Administration; AERS; Adverse Event Reporting System; ALT; alanine aminotransferase; ULN; upper limit of normal; NDA; new drug application; EMA; European Medicines Agency; PDR; Physician's Desk Referen
Inclusion of Human Intravenous Study Data in New Drug Applications-Impact of the Japanese Guidance
Keywords: برنامه دارویی جدید; clinical pharmacokinetics; bioavailability; regulatory science; pharmacokinetics; solubility; intravenous administration; new drug application; guidance;
Devices for intradermal vaccination
Keywords: برنامه دارویی جدید; WHO; World Health Organisation; EMA; European Medicines Agency; CDSN device; Convergent-divergent supersonic nozzle device; CST devices; Contoured shock tube device; PMED; Particle-mediated epidermal delivery; EPI; Epidermal powder immunisation; CPMP; C
Carbohydrate polymers: Applications and recent advances in delivering drugs to the colon
Keywords: برنامه دارویی جدید; AcGGM; O-acetyl-galactoglucomannan; AELC-PAD; anion exchange liquid chromatography with pulsed amperometric detection; AG; arabinogalactan; CAP; cellulose acetate phthalate; CSA; chitosan acetate; Dex-MA-SA; methacrylated and succinic derivative of dextra
Impact of “Guidance for Industry: Clinical Pharmacokinetic Studies of Pharmaceuticals” on New Drug Approvals of Central Nervous System Drugs in Japan
Keywords: برنامه دارویی جدید; central nervous system; clinical pharmacokinetics; MHLW guidance; new drug application;
Adaptive clinical trials for new drug applications in Japan
Keywords: برنامه دارویی جدید; Adaptive design; Interim analysis; New drug application;
Industrial perspective in ocular drug delivery
Keywords: برنامه دارویی جدید; Ocular drug delivery; Eye drops; Suspensions; Ointments; Gels; Dosage forms; Mucoadhesives; Regulatory requirements; New drug application; Marketing authorization application; Clinical trial application; Investigational new drugs
Challenges and lessons learned since implementation of the safety pharmacology guidance ICH S7A
Keywords: برنامه دارویی جدید; CNS; central nervous system; FDA; food and drug administration; GLP; good laboratory practice; GMP; good manufacturing practice; ICH; international conference on harmonization; IND; investigational new drug; NDA; new drug application; PMDA; pharmaceutical