PDA journal 资料交换

七星痣

断断续续收集了74篇PDAjournal 文章，想和各位交换些PDA技术报告、手册、ISPE的指南，欢迎来换。
清单如下：
A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products.pdf
A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems.pdf
A Consensus Rating Method for Small Virus-Retentive Filters. I. Method Development.pdf
A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error.pdf
A Model of Analysis Analytical Methodology For Biopharmaceutical Quality Control.pdf
A simple and fast method for the simultaneous quantification of six.pdf
Adapting to Biology Maintaining Container–Closure System Compatibility with the Therapeutic Biologic Revolution.pdf
Advice on Degradation Products in Pharmaceuticals A Toxicological Evaluation.pdf
An Improved Method of Predicting Extinction Coefficients for the.pdf
Application of the Finite Elemental Analysis to Modeling Temperature Change of the Vaccine in an Insulated Packaging Container during Transport.pdf
Assessing the risk of leachables from single-use bioprocess containers through protein quality characterization.pdf
Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients_ Are They Critical Quality Attributes.pdf
Change Control Special Edition_1.pdf
Classification of Glass Particles in Parenteral Product Vials byVisual, Microscopic, and Spectroscopic Methods.pdf
Container Closure Integrity Testing - Practical Aspects and Approaches in the Pharmaceutical Industry.pdf
Data Integrity History Issues and Remediation of Issues.pdf
Development of a Dye Ingress Method to Assess Container-Closure Integrity Correlation to Microbial Ingress.pdf
Development of a Dye Ingress Method to Assess Container-Closure.pdf
Development of a Premium Quality Plasma-derived IVIg.pdf
Effect of Stopper Processing Conditions on Moisture Content and Ramifications for Lyophilized Products Comparison of Lowa and High Moisture Uptake Stoppers.pdf
Establishing Acceptable Limits of Residual DNA.pdf
Evaluation of Terminal Sterilization of Large-Volume Parenterals as a Biological Indicator for Bacillus oleronius .pdf
Evaluation of the General Solution Compatibility of Polymer Materials Used in Medical Devices such as Syringes.pdf
EvaluationoftheMicroWorks,Inc.SwabSamplingSystem.pdf
Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes Filling Parameter Investigation and Optimization.pdf
Formulation Design and Development of Parenteral Suspensions.pdf
Formulation Optimization of Long-acting Depot Injection of Aripiprazole by Using D-optimal Mixture Design.pdf
FormulationsintoPre-filledSyringesInvestigatingFillingofHighConcentrationMonoclonalAntibody.pdf
Headspace Gas Ingress by Using Frequency Modulation Method Development for Container Closure Integrity Evaluation.pdf
IdentificationofAntioxidantsforPreventionof.pdf
Impact of Vial Capping on Residual Seal Force and Container Close Integrity.pdf
Implementation of Parallelism Testing for Four-Parameter.pdf
Implementation of Plate Imaging for Demonstration of.pdf
Improvement in Photostability of Pantoprazole Sodium by Microencapsulation.pdf
In-Process Microbial Testing Statistical Properties of a Rapid Alternative to Compendial Enumeration Methods.pdf
Industry Perspective on the Medical Risk of Visible Particles in.pdf
Intravial distribution of moisture during the secondary drying stage of freeze drying.pdf
Introduction and Workshop Summary Advanced Technologies for Virus Detection in the Evaluation of Biologicals??Applications and Challenges.pdf
Life Cycle Assessment of Cleanroom Coveralls Reusable and Disposal.pdf
Liquid Biopharmaceutical FormulationThe Role of Investigation of Freeze Thaw-Related Quality Attributes of .pdf
Management and Control and Preparing for Data Integrity  Points to Consider Best Practices for Document Data Inspection.pdf
Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying--the Road to Manufacturing Scale.pdf
Modes of Degradation and Impurity Characterization in rhPTH.pdf
Mouse Minute Virus (MMV) Contamination.pdf
Multiproduct Resin Reuse for Biopharmaceutical Manufacturing Methodology and Acceptance Criteria.pdf
Organic Solvents for Pharmaceutical Parenterals and Embolic Liquids A Review of Toxicity Data.pdf
Oxidation of Protein by Vaporized Sanitizing Agents.pdf
PDA cleaning and cleaning validation.pdf
Pharmaceutical Development of a Parenteral Lyophilized Formulation of the Novel Antitumor Agent Aplidine.pdf
Points to consider for aseptic processing 2003.pdf
Points to Consider for Aseptic Processing Part 1 January 2015.pdf
Points to Consider Fundamental Concepts in Data Integrity.pdf
Points to Consider Technical Product Lifecycle for Managing Post-approval ChangesManagement. Pharmaceutical Quality System Effectiveness .pdf
Polydopamine coated graphene oxide for anticorrosive reinforcement of water-borne epoxy coating .pdf
Product lifecycle management communication and knowledge exchange.pdf
Product lifecycle management PQS effectiveness for managing post-.pdf
ProposalonHowToConductaBiopharmaceutical process fmea.pdf
Quality Control of Gardeniae Fructus by HPLC-PDA Fingerprint Coupled with.pdf
Quantitative Microbial Risk Assessment of Pharmaceutical Products.pdf
Ready-to-fill sterile components Kit-sterile assurance and its future prospect.pdf
Recognition and Identification of UV-absorbing Leachables in EPREX ? Pre-filled Syringes An Unexpected Occurrence at a　Formulation　Component Interface.pdf
regulatory guidances I would like to see changed part 1.pdf
regulatory guidances I would like to see changed part 2.pdf.pdf
Risk-basedStrategytoDetermineTestingRequirement.pdf
Scaling from Discs to Pleated Devices.pdf
Screening of preservatives by HPLC-PDA-ESIMS A focus on both.pdf
Setting Alert and Action limits in the presence of significant.pdf
Solubility and Stability Enhancement of Atorvastatin by Cyclodextrin Complexation.pdf
The Compliance and Science of Blend Uniformity Analysis.pdf
The Effect of Aggregation Inhibitors and Antioxidants on the Stability of Hemin Solutions.pdf
Vacuum Decay Container Closure Integrity Testing.pdf
Vacuum Decay ContainerClosure Integrity Testing Technology. Part 2. Comparison to Dye Ingress Tests.pdf
Vapor Phase Hydrogen Peroxide Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product - Hydrogen Peroxide Uptake and Impact on Protein Quality.pdf
Viral Inactivation Low pH and Detergent.pdf

七星痣

亦心 发表于 2019-3-8 13:10
你想换什么？怎么换？

有PDA TR60-2么？

mr_rain420

PDA TR60-2 不过也是部分，不完整

亦心

你想换什么？怎么换？

剑魔

这些够不够格

七星痣

剑魔 发表于 2019-3-8 13:38
这些够不够格

你有的我都有，还比你的多些

剑魔

把你整套的PDA发出来啊，确实没有什么资料，ISO有没有兴趣。

剑魔

七星痣 发表于 2019-3-8 13:52
有PDA TR60-2么？

网上是找不到完整版

七星痣

剑魔 发表于 2019-3-8 14:35
把你整套的PDA发出来啊，确实没有什么资料，ISO有没有兴趣。

基本都有，ISO的目前用的基本不缺，如果有ASTM和ISPE计算机验证相关的可以换

剑魔

那就真的没有你想要的了

木木之家

都是好东西啊，我都想要

亦心

七星痣 发表于 2019-3-8 13:52
有PDA TR60-2么？

有的

亦心

七星痣 发表于 2019-3-8 14:41
基本都有，ISO的目前用的基本不缺，如果有ASTM和ISPE计算机验证相关的可以换

你加我Q：1595538870

七狼

虽然看不懂，但是好像很厉害的样子

zyjkf

你想要的我都的，你有的我有，所以不换

麦田.守望

交换太浪费时间了

想要TR 18、30(2)、43、50、53、55、57-2、58

胜利者

二楼的大咖太牛

麦田.守望

剑魔 发表于 2019-3-7 20:38
这些够不够格

求TR18、43

tyty999

PDA TR60-2有完整版本不？？

201300

列出你的需求