ライフサイエンスコーパス: drug product

1 he primary sequence of a protein therapeutic drug product.

2 e stability and bioavailability of the final drug product.

3 decisions made concerning the potency of the drug product.

4 responsible for color change in stressed mAb drug product.

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

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

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

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

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

10 es to mitigate aggregation of pharmaceutical drug products.

11 ng is not typically available when analyzing drug products.

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

13 ty for detection of counterfeit glycoprotein drug products.

14 c profiles were analyzed and compared across drug products.

15 -release drug products to identify potential drug products.

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

17 ifferences between biosimilar and originator drug products.

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

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

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

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

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

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

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

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

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

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

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

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

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

31 1997 requires that the QA of compounded PET drug products be in compliance with the PET compounding

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

89 The 3 drug products were considered bioequivalent because the

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

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

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