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  • 1
    Keywords: Pharmaceutical technology ; Pharmacy ; Pharmaceutical Sciences/Technology ; Pharmacy ; Springer eBooks
    Description / Table of Contents: Evolving Challenges in Developing Naturally-Derived Complex Mixtures into Drugs: U.S. Experience and Perspective -- Regulatory Landscapes for Approval of Naturally-derived Complex Mixture Drugs -- Complex Natural Product Heparin: Biosynthesis, Biology and Application via Synthetic Heparins -- Traditional Chinese Medicine Herbal Drugs: From Heritage to Future Developments -- Analytics on Farm-Dust Extract for Development of Novel Strategies to Prevent Asthma and Allergic Disease -- Analytical Tools for Physicochemical Characterization and Fingerprinting -- NMR in the Characterization of Complex Mixture Drugs -- Mass Spectrometry in the Characterization of Complex Drugs -- Scientific Considerations in the Approval of Complex Generi -- Raw Materials Production and Manufacturing Process Control Strategies -- Heparin Contamination and Issues Related to Raw Materials and Controls -- Pharmacology and Toxicology Concerns of Impurities -- Immunogenicity risks for Naturally Derived Complex Drugs -- Development of Plant-Derived Mixtures as Botanical Drugs: Clinical Considerations -- A Totality-of-Evidence Approach to Ensuring Therapeutic Consistency of Naturally Derived Complex Mixtures -- Economic Considerations for Complex Mixture Drugs -- Drug Discovery from Complex Mixtures: Serendipity, Screening and Characterization -- Integrated Approach for Characterization of Highly Heterogeneous Drugs
    Abstract: This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use
    Pages: VI, 331 p. 61 illus., 41 illus. in color. : online resource.
    ISBN: 9783030117511
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  • 2
    ISSN: 1573-904X
    Keywords: dissolution ; chewing gum ; phenylpropanolamine hydrochloride ; in vitro-in vivo correlation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract A novel dissolution apparatus was developed for medicated chewing gum products. A prototype gum product containing phenylpropa-nolamine hydrochloride (PPA) was used to evaluate the apparatus. The apparatus consists of a conical Teflon base and a rotating, ribbed Teflon plunger suspended in a dissolution vessel. Parameters evaluated were rotation speed, plunger frequency, medium volume, medium type, medium sampling location, number of plunger ribs, and number of gum pieces. Samples were taken over a 20-min period and samples were analyzed by HPLC. Cumulative percentage re-leased-versus-time profiles were obtained for each parameter evaluated. Statistical analysis of the gum product indicated that the only significant differences occurred at the lowest rotation speed and lowest plunger frequencies. A Level A correlation was found between the in vitro release profile for the 20-rpm and 30-cycles/min plunger frequency and the in vivo chew-out study.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1573-904X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Following the administration of primaquine diphosphate (20 mg/kg IP), six metabolites of primaquine were found in the bile of rats. Quantitative HPLC of the metabolites revealed that the sum of the six metabolites excreted in the bile represented a quantitative recovery of the dose of primaquine.
    Type of Medium: Electronic Resource
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  • 4
    ISSN: 1573-904X
    Keywords: furosemide ; sucralfate ; adsorption ; bioavailability ; diuretic effect
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
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  • 5
    ISSN: 1574-6941
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Biology
    Notes: Composting relies on a complex network of bacteria and fungi to process crude organic material. Although it is known that these organisms drive dynamic changes in temperature and pH, little is known about the temporal dynamics of fungal populations during the rise to thermophilic conditions. This study employed F-ARISA (fungal-automated rRNA intergenic spacer analysis) and 18S rRNA gene cloning and sequencing to examine changes in community structure during this period. Sequencing of the 18S rRNA portion of cloned F-ARISA products revealed the presence of four distinct fungal genera including Backusella sp., Mucoraceae, Geotrichum sp. and the yeast Pichia sp. Based on the presence and absence of these ARISA operational taxonomic units (A-OTUs), we observed a shift in fungal community structure between 48 and 60 h. This change in community structure preceded a rise in pH and coincided with an increase in temperature. Clone libraries constructed using fungi-specific 18S rRNA primers contained sequences similar to several other fungal genera including Penicillium sp., Aspergillus sp., Hamigera sp., Neurospora sp. and the yeast Candida sp. While the fungal species richness was relatively low at any time point, the community structure was dynamic and paralleled changes in bacterial community structure.
    Type of Medium: Electronic Resource
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  • 6
    Electronic Resource
    Electronic Resource
    Oxford, UK : Blackwell Publishing Ltd
    ISSN: 1749-6632
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Natural Sciences in General
    Type of Medium: Electronic Resource
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  • 7
    ISSN: 1089-7690
    Source: AIP Digital Archive
    Topics: Physics , Chemistry and Pharmacology
    Notes: The ring-opening reaction of 1,3-cyclohexadiene in cyclohexane solution and the subsequent photoproduct cooling dynamics have been investigated by using two-color transient absorption kinetic measurements and novel time-resolved absorption spectroscopy in the 260–300 nm spectral region. The initial photoproduct in this reaction, s-cis,Z,s-cis-1,3,5-hexatriene (cZc-HT) is formed on a ∼250 fs time scale. Spectra deduced for time delays very close to zero, as well as calculated Rice–Ramsperger–Kassel–Marcus unimolecular reaction rates, provide strong evidence that the quantum yield for the reaction is determined before any relaxation occurs on the ground state. Upon formation, the vibrationally excited hexatriene photoproduct is able to isomerize around C–C single bonds freely. As a result, the evolution observed in the transient absorption measurements represents a combination of rotamer population dynamics and thermalization due to energy transfer to the solvent. Three distinct time scales for relaxation are observed. These time scales correspond approximately to the development of an evolving equilibrium of Z-HT rotamers (1–5 ps), vibrational cooling and thermal equilibration with the surroundings (10–20 ps), and activated isomerization of trapped cZt-HT to tZt-HT ((very-much-greater-than)100 ps). © 1998 American Institute of Physics.
    Type of Medium: Electronic Resource
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  • 8
    Electronic Resource
    Electronic Resource
    College Park, Md. : American Institute of Physics (AIP)
    The Journal of Chemical Physics 103 (1995), S. 7877-7886 
    ISSN: 1089-7690
    Source: AIP Digital Archive
    Topics: Physics , Chemistry and Pharmacology
    Notes: Femtosecond laser studies have been performed to investigate the initial photodissociation reactions of I2–mesitylene charge transfer complexes. Photodissociation occurs along both the I2–mesitylene "bond'' and the I–I bond with a branching ratio of 2:3 for the two reaction coordinates. Following excitation at 400 nm, geminate recombination occurs along both reaction coordinates. The reformed I2–mesitylene complexes are formed vibrationally hot and relax on a time scale of 13 ps. The I–mesitylene spectrum is fully developed within 500 fs of the pump pulse. Approximately 40% of the I–mesitylene complexes undergo geminate recombination on a time scale of 14 ps. Most of the remaining complexes recombine with their original partners on a time scale of 400 ps. The initial anisotropy of the photoproduct absorption is 0.09±0.02. This low anisotropy is a direct result of the geometry of the complex and nature of the electronic transition rather than indicative of ultrafast motion toward an asymmetric transition state preceding dissociation. © 1995 American Institute of Physics.
    Type of Medium: Electronic Resource
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  • 9
    ISSN: 1574-6941
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Biology
    Notes: The initial phase of composting is the most dynamic part of the process and is characterized by rapid increases in temperature, large swings in pH, and the degradation of simple organic compounds. DNA samples were taken from an active compost system to determine the microbial 16S rRNA gene sequences that were present during this phase. We observed two significant shifts in the composition of the microbial community, one between 12 and 24 h and the other between 60 and 72 h into the process using automated 16S–23S rRNA intergenic spacer amplification (ARISA). The 16S rRNA gene sequences adjoining the most common ARISA fragments at each time point were determined. We found that sequences related to lactic acid bacteria were most common during the first 60 h and Bacillus-type sequences were most common between 72 and 96 h. While the temperature increased steadily over the first 96 h, the pH dropped after 12 h and increased after 60 h correlating with the shift from Bacillus to lactic acid sequences and the later return to Bacillus-type sequences.
    Type of Medium: Electronic Resource
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  • 10
    ISSN: 1520-5126
    Source: ACS Legacy Archives
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
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