ライフサイエンスコーパス: drug product

1 he critical quality attributes (CQAs) of the drug product.

2 nd binding activity of the three mAbs in the drug product.

3 ss the lot-to-lot consistency of this unique drug product.

4 from other pharmaceutical components in the drug product.

5 oth an active substance or a formulated mRNA drug product.

6 e acetate in situ forming implant as a model drug product.

7 rocess parameters, and the attributes of the drug product.

8 t in tedious method development for each new drug product.

9 otein (HCP) impurities in the final antibody drug product.

10 tumorigenicity from the engrafted gcHBB-SCD drug product.

11 tially reducing the therapeutic index of the drug product.

12 of the desired quality characteristics of a drug product.

13 he primary sequence of a protein therapeutic drug product.

14 nces between different pellets from the same drug product.

15 e stability and bioavailability of the final drug product.

16 decisions made concerning the potency of the drug product.

17 responsible for color change in stressed mAb drug product.

18 the quality, efficacy, and stability of the drug product.

19 logies and as a method to detect counterfeit drug products.

20 onized and sensible QA standards for all PET drug products.

21 p better in vitro methodology for 3D printed drug products.

22 for two different types of microsphere-based drug products.

23 promise the stability and bioavailability of drug products.

24 is a critical task to ensure the quality of drug products.

25 tudy was performed on intact oligonucleotide drug products.

26 characteristics of other challenging complex drug products.

27 the quantification of five high-risk HCPs in drug products.

28 try regarding the control of nitrosamines in drug products.

29 correlative techniques to examine commercial drug products.

30 s been validated through clinically approved drug products.

31 aceutical research by producing personalized drug products.

32 measured NDMA, NDEA, and DMF in 30 finished drug products.

33 gs) on-market, immediate-release lamotrigine drug products.

34 es to mitigate aggregation of pharmaceutical drug products.

35 ifferences between biosimilar and originator drug products.

36 ng is not typically available when analyzing drug products.

37 property and a relevant in vivo response of drug products.

38 ty for detection of counterfeit glycoprotein drug products.

39 c profiles were analyzed and compared across drug products.

40 -release drug products to identify potential drug products.

41 There were 53 studies for 33 drug products, 12 (23%) were evaluated for safety only;

42 For 6 of the 10 drug products (60%), the number of Native Hawaiian and P

43 ed HCP analysis of eight commercial antibody drug products (7 mAbs and 1 Fc-fusion protein) using the

44 ical consequences and wasnot detected in the drug product administered to this patient or in any drug

45 Clinical trials of various drug products administered in the peri-transplant period

46 y that leverages expectations for parenteral drug products administered via more conventional routes

47 hcare costs, including those associated with drug product administration and patient compliance.

48 important for assessing the effectiveness of drug products after marketing authorization showing how

49 rgoid AIT products (from here on called: AIT drug products; AIT-DPs) was developed using a fluorescen

50 ssessing different L:G ratios when used in a drug product and characterizing individual PLGAs.

51 pical steps involved in the manufacturing of drug product and could result in complex physical and ch

52 No adverse reactions to the investigational drug product and no abnormal clonal proliferation or leu

53 maintaining the quality and integrity of the drug product and thus ensuring patient safety.

54 s performed using publicly available data on drug products and demographic subgroups from Drugs@fda i

55 pharmaceutical cocrystals to afford improved drug products and drug substances will interest research

56 g features for its application in 3D printed drug products and nanofiber-based drug delivery systems.

57 In this study, 18 approved finished drug products and nine simulated counterfeits were succe

58 Numerous RX and OTC drug products and supplements from a wide range of thera

59 different classes of marketed pharmaceutical drug products and the syntheses of various drug substanc

60 he task becomes particularly challenging for drug products and vaccines containing nanomaterials, whe

61 ective development and review of recombinant drug products and will be instrumental in a wide area of

62 as a tool for the quality assessment of mAb drug products and would represent an improvement over cu

63 duct ingredients (API) in drug substances or drug products, and its applicability is illustrated with

64 ng the environment via disposal of plastics, drug products, and other chemicals.

65 ign immunogenicity risk levels to biological drug products, and present risk level-based 'fit-for-pur

66 Most approved protein drug products are administered intravenously, imposing e

67 Many solid-dose oral drug products are engineered to release their active ing

68 rmulations is essential to ensure that final drug products are free from endotoxin contamination.

69 The present results suggest that LNP drug products are highly complex and diverse in nature,

70 suitability of mRNA-lipid nanoparticle (LNP) drug product as an appropriate vaccine for emergency res

71 In pharmaceutical analysis, the results of drug product assay testing are used to make decisions re

72 ticles, well above that detected in marketed drug products, at least in this in vitro system.

73 etween the expected API barcode and finished drug product barcode, the identity of API present can be

74 1997 requires that the QA of compounded PET drug products be in compliance with the PET compounding

75 vels can negatively impact the shelf life of drug products but are challenging to identify by liquid

76 capsulation technology may not stabilize BPO drug products but that cold storage may greatly reduce b

77 ation assay, which can detect aCD3 HD in TDB drug product by exploiting its ability to activate T cel

78 to verify the content uniformity of a liquid drug product by quantifying the hydrogen populations wit

79 DA) is tracking the use of nanotechnology in drug products by building and interrogating a technical

80 t of the Raman barcode for identification of drug products by comparing the known peaks in the API re

81 Residual host cell proteins (HCPs) in the drug product can affect product quality, stability, and/

82 s that are highly pure and well-defined, LNP drug products can exhibit heterogeneity in size, composi

83 attributes of controlled release microsphere drug products can greatly impact their release profile a

84 Aggregation of pharmaceutical drug products can occur during manufacturing, processing

85 improved functional T cell phenotype in the drug product compared with those with less durable respo

86 lation of monoclonal antibody tracers into a drug product compliant with current good manufacturing p

87 Food and drug products contain diverse and abundant small-molecul

88 ducts show an increase in the submissions of drug products containing nanomaterials over the last two

89 ntifies several trends in the development of drug products containing nanomaterials, including the re

90 ing the rate and extent of drug release from drug products containing particulates, such as emulsions

91 tion of 1.2%, 1.0%, and 1.2% of oxidation in drug products containing the biopharmaceuticals Rituxima

92 Potential infiltration of counterfeit drug products-containing the wrong or no active pharmace

93 cted the stability of drug products, whereas drug products could safely contain 1.5 ppm lipoprotein l

94 sed human neural stem-cell line from which a drug product (CTX-DP) was developed for allogeneic thera

95 es in response between components of a model drug product (Cymbalta) and its associated cleaning agen

96 es can be immunogenic and are of concern for drug product development in the biotechnology industry.

97 of water in tablets, (b) stability study in drug product development, and (c) representative sample

98 ulation screening as a critical step for new drug product development, and how utilizing hydrophobic

99 igence based on human learning to accelerate drug product development, ensure stringent quality contr

100 ce and enable more efficient complex generic drug product development.

101 provide rational design guidance in hydrogel drug product development.

102 eight ratios, a major concern for industrial drug product development.

103 with special incentives for pediatric orphan drug-product development.

104 rticulate (VP) matter in therapeutic protein drug products (DPs) is a quality attribute that can impa

105 le, high purity, and high dose bacteriophage drug products (DPs) suitable for clinical usage would be

106 Drug products (DPs) were generated for all enrolled pati

107 , unknown isomeric degradant in a formulated drug product during an accelerated stability study.

108 R strategy for routine testing of formulated drug products during drug development.

109 aring the 20 mg/kg dose level of ENHANZE(TM) drug product (EDP) versus no-EDP was conducted in a subs

110 kg (n=5) or 20 mg/kg (n=5) N6LS with ENHANZE drug product (EDP), recombinant human hyaluronidase PH20

111 With increasing numbers of new mAb drug products emerging in the market, the need for a rob

112 Long-acting injectable (LAI) drug products enable the controlled release of a drug ov

113 urate quantification of lipases/esterases in drug products enables better understanding and compariso

114 designed a fully human, rapamycin-regulated drug product for targeting CD33+ tumors called dimerizai

115 itation of free acid forms in pharmaceutical drug products formulated as salts is presented.

116 biquitous and especially high among users of drug products formulated with phthalates.

117 and guides the peptide synthesis process and drug product formulation in the pharmaceutical industry.

118 ience as it transitions from conditions of a drug product formulation to the homeostatic state of the

119 onic liposomes offer effective protection of drug product from nucleases and enable distribution to d

120 fluid. Our objective was to screen finished drug products from Europe and USA for nitrosamine impuri

121 ence method that creates digital versions of drug products from images of exemplar products.

122 Despite similar vector copy numbers in the drug product, gene-marking in peripheral blood mononucle

123 Four somatropin drug products (Genotropin, Norditropin, Jintropin, and O

124 monoclonal antibodies (mAbs) into one final drug product has gained significant popularity recently

125 nt (API) at higher than acceptable levels in drug products, has led regulators to request a detailed

126 anostic applications and some liposome-based drug products have already stepped from the lab-bench to

127 In recent years, biopharmaceutical drug products have become hugely successful.

128 tionally or unintentionally added to food or drug products, have also led to the appearance of previo

129 and heat-stressed monoclonal antibody (mAb) drug product in liquid formulation.

130 ce active pharmaceutical ingredients and the drug product in one integrated system.

131 easuring the dissolution or degradation of a drug product in vitro play a crucial role in predicting

132 is is an effective modelling tool to predict drug product in vivo performance based on in vitro relea

133 nies to obtain full dissolution profiles for drug products in a variety of different conditions, as r

134 estigating the intestinal behaviour of these drug products in humans, hindering the complete translat

135 ectral fingerprinting approaches directly to drug products in order to systematically characterize st

136 NDMA and DMF were quantified for metformin drug products in simulated gastric fluid with different

137 st approved subcutaneously (SC) administered drug products in the US, the recommended injection sites

138 mainly accessible for smaller firms, orphan drugs, products in certain therapeutic areas, first-in-c

139 all the drugs (drug chemical ingredients or drug products) in a drug class are associated with an AE

140 nization Act of 1997 stipulates that all PET drug products, in due course, must meet the requirements

141 y requirements for identity testing on final drug products, in-process identity testing is implemente

142 ug Application (ANDA) submission for ER oral drug products included adequate IVIVC data to enable the

143 Based on labeling information, 6 RX drug products included DBP as an excipient, and 45 speci

144 AUC, C(max), and T(max)) for SC administered drug products including therapeutic proteins and peptide

145 teristic that affects the performance of the drug product, including stability, pharmacokinetics, sed

146 y for continuous manufacturing processes for drug products, including detecting special cause variati

147 ement of physical properties of nano-enabled drug products, including liposomes and polymeric nanopar

148 up 2A carcinogens, were detected in finished drug products, including metformin, ranitidine, sartans

149 f the Raman spectra of both API and finished drug products into a barcode representation by assigning

150 antibodies (mAbs) within a combined antibody drug product is required for preclinical and clinical dr

151 API) within polymer-based controlled release drug products is a critical quality attribute (CQA).

152 es in therapeutic bispecific antibody (bsAb) drug products is essential to support development and qu

153 ngly, development of IVIVCs for such complex drug products is highly desirable.

154 remarket information (which is available for drug products) is often missing so that possible public

155 1% lower concentration values compared with drug product labels for eteplirsen, inotersen, and incli

156 of new pharmaceutical technologies, and new drug products leading to continuous manufacturing proces

157 icron variant emerged in 2021, many antibody drug products lost potency, including Evusheld and its c

158 -approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warni

159 vides a framework for successful transfer of drug product manufacturing process from small-scale to t

160 dent test sets collected from the continuous drug product manufacturing process not only demonstrated

161 In this work, we show that revised drug product matrixes, including mildly acidic, histidin

162 e nasal route for an oxycodone HCl ER tablet drug product may include methods to characterize dissolu

163 in color or shape, and switching among these drug products may interrupt medication use.

164 hemistry (both drug substance and formulated drug product), nonclinical (pharmacology, pharmacokineti

165 from 30mg/day to 240mg/day of the formulated drug product of HDACi 109, RG2833.

166 od's sensitivity for the analysis of protein drug products of different secondary structure.

167 acterization by LC-MS/MS ultimately leads to drug products of superior safety and quality.

168 ve been approved by the Division of Oncology Drug Products of the FDA for the treatment of malignanci

169 at this depletion is maintained in the final drug product, of which the delta(15)N, delta(13)C, and d

170 nimal and human safety studies required of a drug product or medical device.

171 Impurities (process/degradation) in peptide drug products originate due to insertion, truncation, de

172 multitude of glycoforms of recombinant hCG (drug product Ovitrelle), we combine established techniqu

173 would provide an indication of the impact on drug product performance and also the study of the effec

174 ay be used to efficiently assess and predict drug product performance in vivo.

175 ted to method repeatability is defined for a drug product potency assay.

176 o make sound risk-based decisions concerning drug product potency, an understanding of the uncertaint

177 logues as contaminating materials in illicit drug products presents a major hazard to first responder

178 he optimal target to pursue and the ultimate drug product profile (combination of modality, potency,

179 n biotherapeutic drugs may be detrimental to drug product quality even when they are present at the s

180 es more challenges for analytical control of drug product quality.

181 post-translationally modified counterparts, drug-product-related impurities and variants, is critica

182 Specifically in this study, drug-product-related impurities of an anti-Clostridium d

183 allows direct and accurate identification of drug-product-related impurities of therapeutic mAbs.

184 ided unbiased absolute quantitation of these drug-product-related variants.

185 red to those observed in vitro for all three drug products, resulting in a weak prediction of the imp

186 sent in a buprenorphine/naloxone combination drug product revealed several compounds whose structures

187 Analysis of the drug product revealed that the anti-CCL20 Ab has unexpec

188 tform method to both drug substance (DS) and drug product samples is also discussed.

189 Each state has drug product selection laws that regulate whether and ho

190 st that there is a need for optimizing state drug product selection laws to promote generic and inter

191 es: The continuous manufacture of a finished drug product starting from chemical intermediates is rep

192 lity model was developed utilizing long-term drug product storage data through shelf life at 5 degree

193 complicated process, especially for complex drug products such as parenteral PLGA microspheres with

194 of developing IVIVCs for complex parenteral drug products such as peptide microspheres.

195 labeling contains critical information about drug products, such as pharmacokinetics and adverse even

196 recommended with any change in formulation, drug product switches are likely to occur without prescr

197 ass spectrometry in 111 over-the-counter BPO drug products tested and maintained at room temperature.

198 For the eight drug products tested in this study, including five emuls

199 Regulatory approval of complex generic drug products that are applied topically to treat skin d

200 s but is quite challenging when dealing with drug products that contain different formulations of act

201 For drug products that contain two dominant ingredients (the

202 The FDA Green Book is a list of all drug products that have been approved by the FDA for use

203 For a total of 8 drug products, the following groups were compared using

204 (DrOn) is a modular, extensible ontology of drug products, their ingredients, and their biological a

205 to characterize the structure of microsphere drug products, this paper proposes X-ray microscopy (XRM

206 We used lists of modified-release drug products to identify potential drug products.

207 c (PK) profiles after topical application of drug products to IVPT findings with mechanistic diffusio

208 eemed prescriptions for phthalate-containing drug products to measure exposure.

209 pectrum to the peaks present in the finished drug product under study.

210 l benzene exposure from formation during BPO drug product use poses significant risks independent of

211 oduct administered to this patient or in any drug product used in this or other trials using the same

212 ity failed to identify any difference in the drug products used or the patient populations enrolled i

213 ) and was recently reported to form when BPO drug products, used for acne and rosacea treatment, are

214 Typically, reliable identification of drug products using common spectral correlation algorith

215 s intrinsically associated with more complex drug product variant profiles and creates more challenge

216 Face model experiments where BPO drug product was applied to polymethyl methacrylate phot

217 d degradation products in API and formulated drug product was facilitated by the development of an ul

218 A prescription-encapsulated BPO drug product was stability tested at cold (2 degrees C)

219 The vector copy numbers in the final drug product were 1.0 and 0.6 copies per cell for the tw

220 No adverse events related to the drug product were observed.

221 Stability samples of a protein drug product were studied using these two 2DLC-CAD-MS me

222 The 3 drug products were considered bioequivalent because the

223 he FDA first approval application for the 10 drug products were evaluated in this study.

224 Then, 6 metformin finished drug products were tested in stomach conditions for 2 h

225 The (68)Ge levels in the final drug products were under the detection limits at all tim

226 in various liquid mixtures, including liquid drug products, were quantified using time-domain (1)H NM

227 the formation of NDMA in metformin finished drug products when added to simulated gastric fluid.

228 1 ppm cathepsin D affected the stability of drug products, whereas drug products could safely contai

229 olysorbate can lead to particle formation in drug products, which is a major quality concern and pote

230 itro play a crucial role in predicting how a drug product will perform in vivo.

231 mpossible to optimize a process for a target drug product with the desired profile without a proper u

232 st draft guidance on nanomaterial-containing drug products with an emphasis on understanding their in

233 osing regimens, potentially leading to novel drug products with increased patient comfort.

234 pneumococcal vaccine intermediates and final drug products with low-level detection (10 pg) and peak

235 Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (

236 ven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (

237 ood and Drug Administration's (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations w

238 participation in clinical trials for the 10 drug products with top sales forecasts in 2024 to the Na

239 participation in clinical trials for the 10 drug products with top sales forecasts was either unknow

240 Islander individuals in clinical trials for drug products with top sales forecasts was found.

241 ically characterized in insulin or rituximab drug products with varying morphologies and ranged from

242 participants in clinical trials ensures new drug products work well across different demographic gro